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MolMed: corporate governance strengthening

Co-optation of two new members of the Board of Directors, resignation of three Directors

Milan, October 22, 2015 – Today the Board of Directors of MolMed S.p.A. (Milan: MLM) co-opted Dr. Riccardo Palmisano and Prof. Didier Trono as new members of the Board of Directors following the resignation from office, during the same meeting, of Mrs. Marina Del Bue, Mr. Germano Carganico and Mr. Lorenzo Salieri, respectively executive Director in charge of internal control and risk management, executive Director and nonexecutive Director. The resigning Directors did not serve on any of the Company’s Internal Committees. In addition, the Board of Directors postponed to the next meeting, scheduled on the 9th of November, any resolution on the co-optation of the third Director, who must comply with applicable legislation upon “gender quotas”, and the verification of the independence requirements of the new Directors and their compliance with the maximum number of offices held in other companies, as defined by the Company.

Marina Del Bue and Germano Carganico decided to resign from the Board to allow the corporate governance strengthening and, maintaining their positions respectively as General Manager Corporate Governance & Administration and Director of Business Development and Strategic Affairs of MolMed, will focus on advancing the numerous and significant activities of the Company.

Lorenzo Salieri’s decision aims to foster a change in the Board of Directors’ composition, allowing members with specific international professional skills in the field to join to the Board; added to the decrease in the number of shares Science Park Raf S.p.A. – winding up – holds in MolMed S.p.A. and the termination of the shareholders agreement concerning the Company, expired on March 2015. The Chairman Prof. Claudio Bordignon, highlighting the outstanding support rendered by the resigning Directors, together with all the members of the Board of Directors and Board of Statutory Auditors, expressed their heartfelt thanks to the outgoing Directors for their profuse and sincere commitment in the performance of their duties.

Dr. Palmisano is non-executive Chairman of the Board of Directors of Genzyme s.r.l., a cutting-edge biotech company, leader in research and development of orphan drugs for rare diseases. During his career, Dr. Palmisano successfully launched a large number of important products in many therapeutic areas, in both retail and hospital markets, participated and supported several international projects, and successfully negotiated pricing and reimbursement for several innovative drugs with the Italian Authorities. In 2008, Dr. Palmisano joined Assobiotec, the trade association, part of Federchimica, brings together Italian biotech companies, becoming Vice President, responsible for biotech pharma and health, in 2010. In recent years, he became involved in several initiatives dedicated to research and innovation: supports a number of start-up companies, in accomplishing the various steps needed to enter into the market; he is a member of the evaluation committee of the “Area Salute” projects at UniCredit Startlab; a member of the Steering Committee of Rare Partners, a non-profit company, dedicated to the development of new therapeutics and diagnostics in the field of rare diseases; as well as a member of the projects evaluation group at AriSLA. Medical Doctor by education (Parma University), his career in the Italian pharmaceutical industry started in 1986 at Farmitalia Carlo Erba (1986), he then moved on to Gruppo Menarini (1988) where he contributed to the development and internationalisation of the first Italian pharmaceutical Group, becoming Director of the Pharmaceutical Division Italy in 1993 and General Manager at Lusofarmaco in 1995. His career in multinational companies started in 2000, year in which he set up all the operations of the Italian branch of Shire Pharmaceutical, in 2003 he was appointed Vice President Commercial Retail Market in GlaxoSmithKline Verona and, lastly, Vice President & General Manager Italy at Genzyme (2005). After the acquisition of Genzyme by Sanofi he was appointed Director of Business Strategy and Development at Sanofi Italia (2012- 2013).

Prof. Trono, already a member of MolMed’s Scientific Advisory Board, from which he resigned following today’s appointment, is a regarded scientist and opinion leader internationally renowned in the field of lentiviral vectors. Prof. Trono has a long-standing interest for interactions between viruses and their hosts. This led him to study the biology of pathogens such as human immunodeficiency virus and hepatitis B virus, and to develop virusbased delivery systems for human gene therapy. In the last decade, his research shifted towards the field of epigenetics, to explore the impact of retro-elements and their controlling mechanisms on the development and physiology of higher organisms, including humans.

After obtaining an M.D. from the University of Geneva and completing his clinical training in pathology, internal medicine and infectious diseases in Geneva and at the Massachusetts General Hospital in Boston, Didier Trono embarked in his scientific career at the Whitehead Institute for Biomedical Research of MIT. In 1990, he joined the faculty of the Salk Institute for Biological Studies (La Jolla – CA) to launch a centre for AIDS research. In 1997, he moved back to Europe, where he took over as Chairman of the Department of Genetics and Microbiology at the University of Geneva (2000-2004), and became Dean of the Basic Sciences Section of the Faculty of Medicine (2001-2004). From 2004 to 2012, he was Deputy Director of “Frontiers in genetics” at the Swiss National Science Foundation, and Dean of the School of Life Sciences at the Swiss Institute of Technology in Lausanne, where he is still a Professor. He is a member of EMBO, the French NationalAgency forAIDS Research, the Swiss National Science Foundation and the Swiss National Research Council. He is the author or co-author of more than 200 publications and holds several patents.

“The appointment of Dr. Palmisano and Prof. Trono”, said Prof. Claudio Bordignon, Chairman and CEO of MolMed S.p.A.,” reflects the Board’s desire to strengthen the Company’s corporate governance with a higher number of directors of great international standing and having the technical expertise in the Company’s most important areas of activity. This also in light of the recent addition to the pipeline. On the other hand the resigning Directors Marina Del Bue and Germano Carganico will continue to support the Board’s activity as executives of the Company”. According to disclosures made to the public and to the Company, to date, Marina Del Bue, Germano Carganico, Lorenzo Salieri, Riccardo Palmisano and Didier Trono do not hold any ordinary shares of MolMed S.p.A.. Prof. Claudio Bordignon, Chairman and CEO of the Company, has been appointed Director in charge of internal control and risk management. The curricula vitae provided by Dr. Palmisano and Prof. Trono, are available on Company’s website (www.molmed.com).

This press release is written in compliance with public disclosure obligations established by CONSOB (Italian securities & exchange commission) resolution no. 11971 of 14 May 1999, as subsequently amended.

—— About MolMed MolMed S.p.A. is a medical biotechnology company focused on research, development and clinical validation of novel anticancer therapies. MolMed’s pipeline includes antitumour therapeutics in clinical and preclinical development: Zalmoxis® (TK) is a cell-based therapy enabling bone marrow transplants from partially compatible donors, in absence of post-transplant immune-suppression, currently in Phase III in high-risk acute leukaemia and under evaluation by EMA for a Conditional Marketing Authorization; NGR-hTNF is a novel therapeutic agent for solid tumours which displays antitumor activity through its specific binding to blood vessels feeding the tumour mass, currently investigated in a broad clinical programme; CAR-CD44v6, an immuno-gene therapy project potentially effective for many haematological malignancies and several epithelial tumours, currently in preclinical development. MolMed also conducts cell and gene therapy projects in collaboration with third parties, offering resources and expertise covering preclinical to Phase III trials activities. These projects include the development and the validation of the manufacturing process and control strategy, and the cGMP production of clinical-grade viral vectors and manufacturing of patient-specific genetically engineered cells. MolMed has its headquartered at the San Raffaele Biotechnology Department (DIBIT) in Milan, Italy, and secondary office at OpenZone, in Bresso (Milan). MolMed is listed on the main market (MTA) of the Milan stock exchange managed by Borsa Italiana (ticker Reuters: MLMD.MI).

Source: MolMed.com

#MolMed #MolMed Claudio Bordignon #MolMed Board of Directors

MolMed: rafforzamento del governo societario

Cooptazione e nomina di due nuovi componenti del Consiglio di Amministrazione, dimissioni di tre Consiglieri

Milano, 22 ottobre 2015 – In data odierna il Consiglio di Amministrazione di MolMed S.p.A. (MLM.MI) ha nominato per cooptazione il Dr. Riccardo Palmisano e il Prof. Didier Trono quali nuovi membri del Consiglio di Amministrazione a seguito delle dimissioni rassegnate, nel corso della medesima seduta, dai Consiglieri Dott.ssa Marina Del Bue, Dott. Germano Carganico e Dott. Lorenzo Salieri dalla carica rispettivamente di Consigliere esecutivo incaricato del sistema di controllo interno e gestione dei rischi, di Consigliere esecutivo e di Consigliere non esecutivo. I tre Consiglieri dimissionari non appartenevano a comitati interni. Il Consiglio inoltre ha rinviato alla prossima riunione, prevista per il 9 novembre, le deliberazioni in merito alla cooptazione del terzo amministratore, il quale dovrà disporre dei requisiti previsti dalla normativa vigente in materia di “quota di genere” e la verifica in capo ai neo nominati Consiglieri dei requisiti di indipendenza nonché del rispetto in capo ai medesimi dei limiti di cumulo degli incarichi stabilito dalla Società. Marina Del Bue e Germano Carganico hanno maturato tale decisione per favorire il rafforzamento del governo societario e, mantenendo le rispettive funzioni di General Manager Corporate Governance & Administration e di Director Business Development and Strategic Affairs della Società, focalizzeranno le proprie energie nello sviluppo delle diverse ed importanti attività della Società.

La scelta di Lorenzo Salieri è dettata dalla volontà di favorire una modifica nella composizione del Consiglio di Amministrazione tale da consentire l’ingresso di nuove figure con specifiche competenze di settore a livello internazionale, anche in considerazione della riduzione della partecipazione detenuta nella società da Science Park Raf S.p.A. in liquidazione, nonché del venir meno del patto parasociale, scaduto nel marzo 2015.

Il Presidente Prof. Claudio Bordignon, sottolineando lo straordinario contributo dei Consiglieri uscenti, unitamente a tutti i componenti del Consiglio di Amministrazione e del Collegio Sindacale, ha espresso i più sentiti ringraziamenti per l’attività profusa nello svolgimento del loro incarico.

Il Dr. Palmisano è Presidente non esecutivo del Consiglio di Amministrazione di Genzyme s.r.l., azienda biotech specializzata nella ricerca e sviluppo di farmaci orfani per le malattie rare. Nel corso della sua carriera ha gestito il lancio di un gran numero di importanti prodotti sul mercato italiano, in molteplici aree terapeutiche, in ambito sia retail che specialistico ed ospedaliero, ha partecipato a numerosi progetti internazionali, ed ha negoziato con successo la registrazione di diversi farmaci innovativi con le Autorità Regolatorie nazionali. Nel 2008 entra in Assobiotec, l’associazione che all’interno di Federchimica raccoglie le aziende che si occupano di biotecnologia in Italia, di cui nel 2010 diventa Vice Presidente delegato alle aree farmaco biotech e salute. Negli ultimi anni si è impegnato in varie iniziative in area ricerca e innovazione: segue alcune start up nel loro percorso di avvicinamento al mercato, fa parte del comitato di valutazione dei progetti in Area Salute di UniCredit Startlab, è membro dello Steering Committee di Rare Partners, società non profit dedicata allo sviluppo di nuove terapie e strumenti diagnostici nel settore delle malattie rare, nonché del gruppo di valutazione dei progetti di AriSLA.

Laureato in Medicina e Chirurgia presso l’Università degli Studi di Parma, inizia la propria carriera nell’industria farmaceutica italiana in Farmitalia Carlo Erba (1986), per poi passare al Gruppo Menarini (1988) dove per oltre 10 anni contribuirà allo sviluppo e all’internazionalizzazione del primo Gruppo farmaceutico italiano, divenendo Direttore della Divisione Farmaceutica Italia nel 1993 e Direttore Generale di Lusofarmaco nel 1995. Nel 2000 comincia la sua esperienza nelle imprese multinazionali: fonda la filiale italiana di Shire Pharmaceutical (2000), successivamente viene nominato Vice Presidente Commercial Retail Market in GlaxoSmithKline a Verona (2003) ed infine Amministratore Delegato e General Manager Italia in Genzyme (2005). Dopo l’acquisizione di Genzyme da parte di Sanofi, assume anche il ruolo di Direttore Business Strategy & Development in Sanofi Italia (2012-2013).

Il Prof. Trono, già membro del Scientific Advisory Board di MolMed, incarico al quale ha rinunciato in conseguenza della nomina odierna, è scienziato e opinion leader di fama internazionale nel campo dei vettori lentivirali. Il Prof. Trono si occupa da lungo tempo dei meccanismi che governano le interazioni tra i virus e loro ospiti. Questo lo ha portato a studiare la biologia di patogeni come il virus dell’immunodeficienza umana e del virus dell’epatite B, e a sviluppare sistemi di veicolazione basati su virus per la terapia genica applicata all’uomo. Negli ultimi dieci anni, l’attività di ricerca del Prof. Trono si è spostata verso l’epigenetica, per esplorare l’impatto dei retro-elementi e dei loro meccanismi di controllo sullo sviluppo e la fisiologia di organismi superiori, inclusi gli esseri umani.

Dopo aver conseguito la Laurea in Medicina presso l’Università di Ginevra ed aver completato la propria formazione clinica in patologia, medicina interna e malattie infettive a Ginevra e presso il Massachussets General Hospital di Boston, il Prof. Trono ha intrapreso la propria carriera scientifica al Whitehead Institute for Biomedical Research del MIT. Nel 1990, trasferitosi al Salk Institute for Biological Studies di La Jolla (California, US), ha varato un centro di ricerche sull’AIDS. Tornato in Europa nel 1997, dopo tre anni ha assunto la Direzione del Dipartimento di genetica e microbiologia dell’Università di Ginevra (2000-2004) e successivamente la Presidenza della sezione Scienze di base della Facoltà di Medicina (2001-2004). Dal 2004 al 2012 è stato Direttore vicario del polo di competenze “Frontiere della genetica” della Fondazione Nazionale della Scienza svizzera e Decano della scuola di Scienze della vita dell’Istituto di Tecnologia svizzero a Losanna, dove tuttora è professore ordinario. È membro dell’EMBO, dell’Agenzia Nazionale francese per la ricerca sull’AIDS, della Fondazione Nazionale della Scienza svizzera e del Consiglio Nazionale svizzero per la Ricerca. È autore o co-autore di più di 200 pubblicazioni e titolare di numerosi brevetti.

“La nomina del Dr. Palmisano e del Prof. Trono”, ha dichiarato il Prof. Claudio Bordignon, Presidente e Amministratore Delegato di MolMed S.p.A., “rispecchia l’intenzione del Consiglio di rafforzare il governo societario con un maggior numero di consiglieri dotati di elevato standing internazionale ed expertise tecnica nei temi più rilevanti per la Società. Questo anche alla luce del recente rafforzamento della pipeline. D’altra parte i Consiglieri dimissionari Marina Del Bue e Germano Carganico continueranno a supportare l’attività del Consiglio nei loro rispettivi ruoli societari”. Sulla base delle comunicazioni rese al pubblico e alla Società, Marina Del Bue, Germano Carganico, Lorenzo Salieri, Riccardo Palmisano e Didier Trono non risultano detenere, ad oggi, alcuna partecipazione nel capitale sociale della Società. La funzione di Amministratore incaricato del sistema di controllo interno e di gestione dei rischi è stata attribuita al Prof. Claudio Bordignon, Presidente e Amministratore Delegato della Società.

I curricula vitae del Dr. Palmisano e del Prof. Trono sono consultabili sul sito societario (www.molmed.com).

—— Il presente comunicato è stato redatto in ottemperanza agli obblighi informativi verso il pubblico previsti dalla delibera CONSOB n. 11971 del 14 maggio 1999 e successive modifiche.

MolMed Informazioni su MolMed MolMed S.p.A. è un’azienda biotecnologica focalizzata su ricerca, sviluppo e validazione clinica di terapie innovative per la cura del cancro. Il portafoglio-prodotti di MolMed include terapeutici antitumorali in sviluppo clinico e preclinico: Zalmoxis® (TK), una terapia cellulare che consente il trapianto di cellule staminali emopoietiche da donatori parzialmente compatibili con il paziente in assenza di immunosoppressione, attualmente in sperimentazione clinica di Fase III per la cura delle leucemie ad alto rischio, e oggetto di richiesta di Conditional Marketing Authorisation presso EMA; NGR-hTNF, un nuovo agente terapeutico per i tumori solidi che mostra un’attività antitumorale attraverso il suo legame specifico con i vasi sanguigni che alimentano la massa tumorale, oggetto di un ampio programma di sviluppo clinico; CAR-CD44v6, progetto di “immuno-gene therapy” potenzialmente efficace contro molte neoplasie ematologiche e numerosi tumori epiteliali, attualmente in fase di sviluppo preclinico. MolMed svolge anche progetti di terapia genica e cellulare in collaborazione con terze parti, mettendo a disposizione risorse e competenze che spaziano dagli studi preclinici alla sperimentazione clinica di Fase III. Tali progetti comprendono lo sviluppo e validazione del processo produttivo e della strategia di controllo e la produzione ad uso clinico, secondo le GMP correnti, di vettori virali e di cellule geneticamente modificate specifiche per il paziente. La Società ha sede legale a Milano, presso il Dipartimento di Biotecnologie (DIBIT) dell’Ospedale San Raffaele, e sede secondaria a Bresso presso OpenZone. Le azioni di MolMed sono quotate al MTA gestito da Borsa Italiana (Ticker Reuters: MLMD.MI). Le azioni di MolMed sono quotate al MTA gestito da Borsa Italiana. (Ticker Reuters: MLMD.MI)

FONTE: MolMed.com

#MolMed #MolMed Claudio Bordignon #MolMed Consiglio Amministrazione

MolMed NGR-hTNF mesothelioma, oral presentation at ASCO 2015

Oral presentation at ASCO 2015 of survival data in poor prognosis patients achieved in the Phase III trial on NGR-hTNF treatment in pleural mesothelioma

Milan (Italy), 1 June 2015 – MolMed S.p.A. (MLM.MI) announces that the complete results of the Phase III trial with its investigational therapeutic NGR-hTNF in mesothelioma were presented and discussed orally in the “Lung Cancer-NSCLC local-regional/SCLC/Other Thoracic Cancers” session at the 51st ASCO Annual Meeting underway in Chicago (IL, USA) from May 29th to June 2nd.

The international phase III trial, which started in 2010 and whose top line results were released in 2014, showed a statistically significant 45% improvement in overall survival in patients who progressed more rapidly after first-line treatment. This outcome was observed in the 50% of patients with a poorer prognosis, while the primary endpoint was not met for the entire population.

In this poor prognosis patient population, the robustness of the benefit induced by NGR-hTNF in combination with chemotherapy, over chemotherapy alone, has been confirmed by the efficacy consistently reported across all patient subgroups, defined on the basis of well-established risk factors (e.g. histology, performance status, age, sex, etc.), and across all the other study endpoints, with NGR-hTNF able to prolong progressionfree survival time by 45%, to reduce early progression rate by 45% and to increase the survival duration in patients with disease control by 65%.

The meaningfulness of results achieved in mesothelioma patients has been further endorsed by additional analyses related to the phase III trial data that were also presented at the ASCO conference in two poster presentations. The first analysis highlighted the value of the clinical parameter – the treatment-free interval after first-line therapy – in easily identifying patients who benefited most from NGR-hTNF treatment and in defining the increased aggressiveness and poor prognosis of disease. The second analysis indicated the rationale underlying the increased NGR-hTNF effects observed in the patient population presenting with disease characterized by an augmented tumor angiogenesis (as assessed by high circulating lactate dehydrogenase levels), and the key role of patient immune status in predicting NGR-hTNF efficacy. Indeed, in those patients who presented with elevated blood markers of angiogenesis and of the immune response, overall survival improved by 72% and progression-free survival by 89% with NGR-hTNF plus chemotherapy compared with chemotherapy alone.

These clinical results are also in line with the drug’s hypothesized mechanism of action, which is based on an improved intratumoral penetration of chemotherapeutic agents and increased tumor lymphocyte infiltration, thanks to NGR-hTNF’s activity on newly formed tumor vasculature.

MolMed’s global effort in the treatment of mesothelioma is further reinforced by the currently ongoing randomized Phase II trial with NGR-hTNF given as a maintenance approach after completion of first-line therapy.

Claudio Bordignon, Chairman and CEO of MolMed, commented: “The oral presentation of the data PRESS RELEASE FROM GENES TO THERAPY 2 discussed at the ASCO meeting acknowledges the value of the results achieved by NGR-hTNF in those patients who suffer from a resistant disease and are most in need of treatment options, and significantly confirms the therapeutic potential of the molecule already observed in other tumor indications evaluated in Phase II trials. The identification of patients who benefit most from NGR-hTNF, their extended survival time, and the consistently reported efficacy represent three key results of the study and, more importantly, offer the perspective of a relevant and appropriate treatment choice for patients with poorer prognosis”.

These results represent the basis for the Company to pursue the next steps, including initiation of the registration process, and the further clinical development of NGR-hTNF.

About MolMed MolMed S.p.A. is a biotechnology company focused on research, development and clinical validation of novel anticancer therapies. MolMed’s pipeline includes two antitumour therapeutics in clinical development: TK, a cell-based therapy enabling bone marrow transplants from partially compatible donors, in absence of post-transplant immune-suppression, in Phase III in high-risk acute leukaemia; NGR-hTNF, a novel vascular targeting agent, in Phase III in malignant pleural mesothelioma and in Phase II in six more indications: colorectal, lung (small-cell and non-small-cell), liver and ovarian cancer, and soft tissue sarcomas. MolMed also offers top-level expertise in cell and gene therapy to third parties to develop, conduct and validate projects from preclinical to Phase III trials, including scale-up and cGMP production of clinical-grade viral vectors, and manufacturing of patient-specific genetically engineered cells. MolMed is headquartered at the San Raffaele Biomedical Science Park in Milan, Italy. The Company’s shares are listed on the main market (MTA) of the Milan Stock Exchange. (Ticker Reuters: MLMD.MI)

FONTE: MolMed.com

#MolMed #MolMed NGR-hTNF mesothelioma #MolMed NGR-hTNF ASCO

MolMed NGR-hTNF mesotelioma: Presentazione orale ad ASCO 2015

Presentazione orale ad ASCO 2015 dei dati sulla sopravvivenza dei pazienti a prognosi sfavorevole ottenuti nello studio di fase III sul trattamento con NGR-hTNF del mesotelioma pleurico

Milano, 1 giugno 2015 – MolMed S.p.A. (MLM.MI) annuncia che i risultati completi dello studio di fase III con il proprio farmaco sperimentale NGR-hTNF nel trattamento del mesotelioma sono stati presentati e discussi oralmente nella sessione “Lung Cancer-NSCLC local-regional/SCLC/Other Thoracic Cancers” al 51° convegno annuale della American Society of Clinical Oncology (ASCO), in corso dal 29 Maggio al 2 Giugno a Chicago (IL,USA).

Il trial internazionale NGR015, iniziato nel 2010 e i cui risultati top line sono stati rilasciati nel corso del 2014, aveva rilevato un incremento statisticamente significativo del 45% della sopravvivenza globale nei pazienti che progrediscono più precocemente dopo il trattamento di prima linea. Questo risultato è stato osservato nel 50% dei pazienti che presenta la prognosi peggiore, mentre l’endpoint primario non è stato raggiunto per l’intera popolazione.

In questi pazienti a prognosi peggiore, la solidità del beneficio indotto da NGR-hTNF in combinazione con chemioterapia, rispetto alla chemioterapia da sola, è stata confermata dall’efficacia consistentemente riportata per tutti i gruppi di pazienti predefiniti in base a riconosciuti fattori di rischio (inclusi: istologia, performance status, età, sesso, etc) e per tutti gli endpoints dello studio, con NGR-hTNF capace di prolungare del 45% la sopravvivenza libera da progressione, di ridurre del 45% il tasso di progressioni tumorali precoci e di incrementare del 65% la durata della sopravvivenza nei pazienti con controllo di malattia.

La rilevanza dei risultati ottenuti nei pazienti con mesotelioma è stata rafforzata da ulteriori analisi correlate ai dati della fase III che sono state illustrate sempre nel corso della conferenza ASCO in due presentazioni poster.

La prima di queste analisi ha evidenziato il valore del parametro clinico – l’intervallo libero da trattamento dopo terapia di prima linea – nell’identificare facilmente i pazienti in grado di ottenere il maggiore beneficio terapeutico da NGR-hTNF e nel definire l’aumentata aggressività e prognosi sfavorevole della malattia. La seconda analisi ha indicato il razionale dell’incrementato effetto terapeutico osservato con NGR-hTNF in questa popolazione, che presenta una malattia caratterizzata da un’aumentata angiogenesi tumorale (come rivelato da elevati livelli circolanti dell’enzima lattato deidrogenasi) e il ruolo chiave dello stato immunitario del paziente nel predire l’efficacia di NGR-hTNF. Infatti, nei pazienti con elevati livelli circolanti dei marcatori dell’angiogenesi e dello stato immunitario, la sopravvivenza globale è incrementata del 72% e la sopravvivenza libera da progressione del 89% con la combinazione di NGR-hTNF e chemioterapia in confronto alla chemioterapia da sola.

Questi risultati clinici sono in linea con l’ipotizzato meccanismo d’azione del farmaco basato su un’incrementata penetrazione dei chemioterapici e infiltrazione linfocitaria nel tumore, grazie all’attività di NGR-hTNF sui vasi tumorali neoformati.

Lo sforzo globale di MolMed nel trattamento del mesotelioma è ulteriormente potenziato dallo studio randomizzato di fase II attualmente in corso con NGR-hTNF impiegato come mantenimento dopo il completamento della terapia di prima linea.

Claudio Bordignon, Presidente e AD di MolMed, commenta: “La presentazione orale dei dati discussi al meeting ASCO riconosce la rilevanza dei risultati di efficacia ottenuti da NGR-hTNF proprio in pazienti con una forma di mesotelioma più aggressiva e che maggiormente necessitano di opzioni terapeutiche, e conferma, in maniera significativa, il potenziale della molecola già espresso in altre indicazioni tumorali testate in fase II. L’identificazione dei pazienti che traggono il maggiore beneficio dal trattamento con NGRhTNF, l’incremento della sopravvivenza e la consistenza dell’efficacia clinica in questa popolazione di pazienti rappresentano tre risultati chiave dello studio e, ancor più importante, offrono la prospettiva di poter proporre una rilevante e appropriata scelta terapeutica per i pazienti a prognosi peggiore”. Questi risultati rappresentano per la Company la base e il razionale per perseguire i prossimi obiettivi inerenti l’attivazione dell’iter registrativo e l’ulteriore sviluppo clinico di NGR-hTNF. Il presente comunicato è stato redatto in ottemperanza agli obblighi informativi verso il pubblico previsti dalla delibera CONSOB n. 11971 del 14 maggio 1999 e successive modifiche.

MolMed MolMed S.p.A. è un’azienda biotecnologica focalizzata su ricerca, sviluppo e validazione clinica di terapie innovative per la cura del cancro. Il portafoglio-prodotti di MolMed comprende due terapeutici antitumorali in sperimentazione clinica: TK, una terapia cellulare che consente il trapianto di midollo osseo da donatori parzialmente compatibili con il paziente, in assenza di immunosoppressione post-trapianto, in Fase III per la cura delle leucemie ad alto rischio; NGR-hTNF, un nuovo agente mirato ai vasi sanguigni tumorali, in Fase III nel mesotelioma pleurico maligno e in Fase II in altre sei indicazioni: carcinomi del colon-retto, del fegato, del polmone a piccole cellule, del polmone non microcitico e dell’ovaio, e nei sarcomi dei tessuti molli. MolMed offre anche competenze di alto livello in terapia genica e cellulare per sviluppo, realizzazione e validazione di progetti conto terzi; tali competenze spaziano dagli studi preclinici alla sperimentazione clinica di Fase III, inclusa la produzione a uso clinico secondo le GMP correnti di vettori virali e di cellule geneticamente modificate specifiche per il paziente. La Società ha sede a Milano, presso il Parco Scientifico Biomedico San Raffaele. Le azioni di MolMed sono quotate al MTA gestito da Borsa Italiana. (Ticker Reuters: MLMD.MI)

FONTE: MolMed.com

#MolMed #MolMed NGR-hTNF mesotelioma #MolMed NGR-hTNF ASCO

MolMed New Data At ASCO On NGR-hTNF Show Significantly Extended Survival

A statistically significant 40% improvement of both overall survival and progression-free survival in a large population of patients, identified by a pre-specified analysis on the prior treatment-free interval, and who presented a very dismal prognosis was reported by MolMed S.p.A. (MLM.MI) this weekend, at the 50th ASCO annual meeting.

These efficacy results were observed in an international randomized Phase III study evaluating the investigational drug NGR-hTNF in combination with best investigator choice in 400 patients with malignant pleural mesothelioma (MPM) who had previously failed a first-line chemotherapy.

The magnitude of treatment effect increased with NGR-hTNF duration and was particularly marked in patients receiving at least three months of therapy, with a median survival time nearly doubled in patients treated with NGR-hTNF compared to control patients: 16.5 vs 9.8 months, respectively.

Claudio Bordignon, Chairman and CEO of MolMed, commented: “The results presented at ASCO on the efficacy of NGR-hTNF in the treatment of the patient affected by the more aggressive form of malignant pleural mesothelioma confirm, in a large Phase III trial, the therapeutic potential of this molecule already observed in Phase II in chemo-resistant squamous NSCL carcinoma, soft-tissue sarcoma, and ovarian carcinoma. Having been able to extend the median survival time to more than 16 months in patients treated for at least 12 weeks is a success for the study and, more important, offers the perspective of a relevant clinical benefit to patients affected by the more aggressive form of mesothelioma. These results represent for MolMed the basis to aggressively pursue the next crucial steps for the future of this molecule: the definition of the best and fastest registration path, and the identification of a suitable partner for offering to NGR-hTNF the possibility to express its full potential as an anti-cancer agent of broad application.”

The data reported at ASCO, mainly obtained in combination with either gemcitabine or vinorelbine in a very aggressive and chemo-resistant disease, assume particular relevance as they are confirmatory of the efficacy previously shown by NGR-hTNF plus gemcitabine in the first-line Phase II study in squamous lung cancer patients.

Furthermore, NGR-hTNF confirmed in this large patient population its very favourable tolerability profile in combination with the three different chemotherapeutic agents administered in this study (gemcitabine, vinorelbine and doxorubicin).

An additional two randomized Phase II studies reported at ASCO meeting clearly established the effect of NGR-hTNF on survival.

In the four-arm randomized Phase II study in sarcoma patients, the low-dose weekly NGR-hTNF plus doxorubicin regimen induced a statistically significant doubled survival time, as compared with the other schedules given at high dose in combination with doxorubicin or as monotherapy at low or high dose. The 3-year survival rate with this schedule exceeded 40% and, notably, similar results were reported for both chemo-naïve and pretreated patients, thus confirming the elevated NGR-hTNF efficacy in more aggressive, chemo-resistant disease.

In the randomized Phase II study in resistant / refractory ovarian cancer patients, NGR-hTNF in combination with an anthracycline improved overall survival in patients with normal or high baseline lymphocyte counts, as compared to patients receiving an anthracycline alone.

Taken together, these clinical evidences are also consistent with the drug mechanism of action, based on both an increased intratumoral chemotherapy uptake and interaction with host immune system.

About NGR-hTNF NGR-hTNF is a novel therapeutic agent for solid tumours which displays antitumor activity through its specific binding to blood vessels feeding the tumour mass. NGR-hTNF is being investigated in a large clinical program, including a Phase III trial in malignant pleural mesothelioma (second line), a Phase II trial in malignant pleural mesothelioma (first-line maintenance therapy) and five Phase II trials in colorectal, lung (small-cell and non-small-cell), liver and ovarian cancer, and soft tissue sarcomas.

NGR-hTNF has been granted Orphan Drug designation for the treatment of mesothelioma and liver cancer in both the EU and the US.

FONTE: MolMed.com

#MolMed #MolMed NGRhTNF #MolMed NGRhTNF ASCO

MolMed TK ASCO new data from the pivotal Phase III randomized trial TK008

MolMed S.p.A. (MLM.MI) provided at the 50th ASCO annual meeting new data from the ongoing randomised pivotal Phase III study on its cell therapy product TK for high-risk acute leukaemia patients transplanted from partially matched (haplo-identical) donors.

The intent-to-treat analysis of the first 24 patients treated with TK indicates a 74% 1-year disease free survival (DFS) as the primary study endpoint: this result largely exceeds the target of 52% DSF for the TK arm vs 30% for the control arm.

Notably, 86% of patients treated with TK were alive at one year (the key secondary study endpoint) and the corresponding figures for patients who achieved immune reconstitution rose to 85% for disease free survival and 100% for overall survival.

The direct impact of TK cells on transplant outcome was confirmed by a very low incidence of relapse (16% – with no relapse in patients receiving higher TK cell doses) and non-relapse mortality (10% – with no deaths observed in patients achieving immune reconstitution).

Claudio Bordignon, Chairman and CEO of MolMed, commented: “We are particularly proud of the results presented today at the ASCO meeting on the pivotal Phase III trial of the TK cell therapy for acute high risk leukemia patients transplanted from partially matched family donors. When we started this study, our goal was to provide all patients affected by the most aggressive forms of leukemia with the opportunity to undergo bone marrow transplantation, by far their best chance for a permanent cure. For this purpose we developed the TK therapy that allows patients lacking a fully matched donor to access a safer transplantation from partially matched family donors, an approach available to nearly all patients. TK is based on the genetic engineering of the donor immune system that can offer a graft without post-transplant immune-suppression and provide for a rapid and complete reconstitution of the immune system. This therapeutic strategy is characterized by low infection risk, low leukemia relapse rate and, consequently, by a higher probability of cure. Today we report data on the first patients enrolled in this study with an outcome that exceed the target of the trial design. These results strongly support our commitment to complete this large pivotal Phase III study. Moreover, the relevance of the data presented at ASCO is an important validation of our strategic decision to pursue Conditional Marketing Authorization for TK in Europe”.

MolMed has been investing on the TK cell therapy that represents today the largest clinical experience of immuno-gene therapy of tumours worldwide. This extensive program was carried out through the implementation of a centralised manufacturing in a single facility for global distribution. This experience, coupled with the new facilities built by MolMed, represent today an ideal platform for all new technologies of tumour immune-gene therapy based on the different strategies of genetic engineering of the immune system.

The Company would like to thank all patients and their families who placed confidence in this new technology and all the investigators from all transplantation centres who participate the Phase III trial and who contributed to the previous studies.

TK008 is coordinated by Dr. Fabio Ciceri, M.D. from the San Raffaele Scientific Institute, principal investigator of the trial who illustrated the results at ASCO and commented: “Initial results of the Phase III study indicate that in haploidentical transplant recipients TK-cell infusions abate non-relapse mortality and leukemia relapse by providing a fast immune recovery in a dose-dependent manner. HSV-TK suicide gene machinery effectively and timely controlled the graft-vs-host disease (GvHD) in 100% of affected patients with no requirement for long-term immune-suppressive treatment. Results obtained so far appear largely superior to the outcomes reported by large EBMT surveys for the two treatment options of TK008 control arm: T-cell depleted and T-cell replete followed by high-dose cyclophosphamide. These results are of particular relevance in light of the more accessible standard option represented by haploidentical transplants.” About TK TK is a cell therapy product, based on the use of genetically engineered donor T cells carrying a “suicide gene”. These cells are administered to patients during the haematopoietic stem cell transplantation for the treatment of high risk leukaemia. TK therapy allows to eliminate the post-transplant immunosuppression treatment thus accelerating the immune reconstitution and controlling the immunological consequences arising from the genetic differences with the donor, known as Graft versus Host Disease (GvHD).

In virtue of this approach, HSCT from partially compatible donors is a safer and more effective option, thus potentially increasing the number of candidates for transplantation. Based on the efficacy and safety data and on the Orphan Drug designation, the Company filed a request for Conditional Marketing Authorisation of TK with the European Medicine Authority in March 2014.

TK008 study TK008 is a pivotal randomised Phase III trial (TK008) in adult patients affected by high-risk leukaemia undergoing transplant of haematopoietic stem cells collected from partially compatible (haploidentical) family donors. The trial compares the outcome of haplo-transplants with or without TK add-backs, with a 3:1 randomisation ratio in favour of the TK arm.

The primary study end-point is disease-free survival (DFS) – which includes both transplant-related mortality and disease relapse – evaluated on 170 patients. The study is powered to detect an increase in 1-year DFS from 30% in the control arm to 52% in the experimental arm. Secondary end-points include overall survival, reduction of transplant-related mortality, safety and patients’ quality of life.

With the aim to provide additional clinical benefit to patients and to significantly increase the potential participation of centres in the trial, the Company implemented in 2012 two important changes in the protocol design of Phase III trial TK008. The first consists in broadening the enrolment criteria to include patients in leukaemic relapse, in addition to those in disease remission; the second change provides for the introduction of a further treatment option in the control arm, based on the use of an unmanipulated transplant followed by cyclophosphamide administration during the post-transplantation period.

FONTE: MolMed.com

#MolMed #MolMed TK leukaemia #MolMed TK ASCO

MolMed reports top line results of NGR-hTNF in the phase III trial in malignant pleural mesothelioma

MolMed S.p.A. (MLM.MI) today announced the results of the double-blinded, placebo-controlled Phase III trial of NGR-hTNF versus best investigator choice in 400 patients with malignant pleural mesothelioma who had previously failed a first-line chemotherapy.

Despite not meeting its primary endpoint of improving overall survival (OS) in the entire population, the study showed a statistically significant (unstratified p=0.02; stratified p=0.01) 40% improvement of OS in patients with poorer prognosis who had progressed during or shortly after first-line chemotherapy. These patients represent 50% of the entire patient population and were identified by a pre-specified analysis based on prior treatment-free interval. This clinical parameter will allow to easily identifying patients who derive most clinical benefit from NGR-hTNF in combination with the chemotherapy of choice. Consistent with the overall survival improvement in this patient population, a 40% percent longer progression-free survival (PFS) was also reported for the NGR-hTNF treated arm in those patients who presented a more aggressive, chemo-resistant disease. In addition to the efficacy data, NGR-hTNF confirmed in this large patient population its very favourable tolerability profile also in combination with the three chemotherapeutic agents administered in this study (gemcitabine, vinorelbine and doxorubicin).

NGR-hTNF has already been granted Orphan Drug designation for the treatment of mesothelioma in both the EU and the US. Claudio Bordignon, Chairman and CEO of MolMed, commented: “The results obtained in a pre-specified population of high-risk patients represent an important reward for the Company’s mission and effort in improving survival and quality of life of cancer patients, even if the primary endpoint was not reached in the entire population. For the first time in malignant pleural mesothelioma a highly significant clinical benefit was achieved in a large subpopulation with the worst prognosis, represented by patients refractory or rapidly progressing after first line treatment. In addition, these data provide confirmation of NGR-hTNF effect on survival already observed in Phase II studies in other indications. Pending a more in depth evaluation, these top line results already provide potential to pursue conditional marketing authorisation and further clinical development in mesothelioma and other indications.”

For the same pathology the Company is running a randomised Phase II study on NGR-hTNF as maintenance therapy after completion of first line chemotherapy (NGR019). The study aims at extending the treatment-free interval of those patients who did not progress after first line, providing them with a long term therapy with a high tolerability profile.

About NGR-hTNF

NGR-hTNF is a novel therapeutic agent for solid tumours which displays antitumor activity through its specific binding to blood vessels feeding the tumour mass. NGR-hTNF is being investigated in a large clinical program, including a Phase III trial in malignant pleural mesothelioma (second line), a Phase II trial in malignant pleural mesothelioma (first-line maintenance therapy) and five Phase II trials in colorectal, lung (small-cell and non-small-cell), liver and ovarian cancer, and soft tissue sarcomas. In particular, completed randomised clinical trials showed statistically significant increase in overall survival in squamous cell NSCLC and soft tissue sarcomas. Recent results from the Phase III study in malignant pleural mesothelioma confirmed the ability of NGR-hTNF in treating particularly challenging cancer indications. Updated results from MolMed clinical development program will be presented at most relevant forthcoming meetings, including the ASCO 2014 in June. NGR-hTNF has been granted Orphan Drug designation for the treatment of mesothelioma and liver cancer in both the EU and the US.

About Phase III trial NGR015

NGR015 is a pivotal randomised, double-blind, placebo-controlled, international, multicentre Phase III trial performed on 400 malignant pleural mesothelioma patients (enrolled in 48 centres in the EU, US, Canada and Egypt) whose disease progressed after a pemetrexed-based chemotherapy. The trial is powered to detect a survival benefit for NGR-hTNF, when combined with best investigator’s choice (BIC), where BIC includes either best supportive care alone or in combination with chemotherapy (either doxorubicin, or gemcitabine, or vinorelbine). NGR-hTNF is administered according to the dose and schedule that were confirmed as the most efficacious in Phase II trials: 0.8 µg/m2 weekly, until disease progression.

About Phase III trial NGR019

NGR019 is a randomised, double-blind, placebo-controlled, international, multicentre Phase II trial on 100 adult pleural mesothelioma patients with non-progressive disease after a pemetrexed-based chemotherapy. The trial is powered to detect a progression-free survival benefit for NGR-hTNF, when combined with best supportive care (BSC). NGR-hTNF is administered according to the dose and schedule that were confirmed as the most efficacious in Phase II trials: 0.8 µg/m2 weekly, until disease progression. Secondary endpoints include overall survival, tumour response, safety and quality of life.

Conditional Marketing Authorisation

The Conditional Marketing Authorisation represents an expedite path for early market authorisation ahead of completion Phase III clinical development. Such anticipated authorisation is mainly based on efficacy and safety evidences accumulated in early studies.

A Conditional Marketing Authorisation may be granted only if all the following requirements are met:

1. the risk-benefit balance of the medicinal product is positive; 2. it is likely that the applicant will be in a position to provide the comprehensive clinical data; 3. unmet medical needs will be fulfilled; 4. the benefit to public health of the immediate availability on the market of the medicinal product concerned outweighs the risk inherent in the fact that additional data are still required. A Conditional Marketing Authorisation allows the Company to commercialise the product in advance and is valid for one year, on a renewable basis. The holder is required to complete ongoing studies or to conduct new studies with a view to confirming that the benefit-risk balance is positive.

About pleural mesothelioma

Pleural mesothelioma is a form of cancer strongly related with repeated exposure to asbestos fibres (for more information please refer to Park et al, Global Magnitude of Reported and Unreported Mesothelioma, Environmental Health Perspectives, 2011). Pleural mesothelioma is a tumor that develops in the tissue that lines the chest cavity. With an incidence of approximately 1/100,000, pleural mesothelioma is still a relatively rare type of cancer, but has been progressing quickly in the past 20 years as incidence rates have continuously increased. Pleural mesothelioma has a long latency period and symptoms are non-specific, so that in most cases diagnosis is difficult before the advanced stage of the disease is reached. Research indicates that pleural mesothelioma may affect each year more than 10,000 people in the EU and the US. Currently, only one therapy has been approved for first-line treatment, whilst the elevated need for first-line maintenance and second line treatment remains unmet. Clinical development of NGR-hTNF is aimed at filling this therapeutic gap.

FONTE: MolMed.com

#MolMed #NGR-hTNF #malignant pleural mesothelioma

TK submission for Conditional Approval validated by EMA

MolMed S.p.A. (Milan:MLM) announces that the European Medicines Agency (EMA) has validated the submission of the Conditional Marketing Authorisation for TK, a novel proprietary investigational cell-gene therapy. The data review of the submitted dossier starts today.

TK is an adjunctive treatment in hematopoietic stem cell transplantation for patients affected by high risk leukaemia. TK has been granted orphan drug status by the European Commission. MolMed is also glad to announce that the Company has been invited by the European Society for Blood and Marrow Transplantation (EMBT) to illustrate the scientific and regulatory path of TK which – with more than 120 patients treated so far – is the largest cell-gene therapy application ever performed. Claudio Bordignon, CEO and president of the Board, will give a presentation on the topic next Tuesday 1st of April during the plenary session of the 40th annual meeting of the EMBT, which will be held in Milan from March 30th to April 2nd.

Conditional Marketing Authorisation The Conditional Marketing Authorisation represents an expedite path for early market authorisation ahead of completion of the pivotal registration studies. Such anticipated authorisation is mainly based on efficacy and safety evidences accumulated in early studies. A Conditional Marketing Authorisation may be granted only if all the following requirements are met:

A Conditional Marketing Authorisation is valid for one year, on a renewable basis. The holder is required to complete ongoing studies or to conduct new studies with a view to confirming that the benefit-risk balance is positive.

About TK TK is a cell therapy product, based on the use of genetically engineered donor T cells carrying a “suicide gene”. These cells are administered to patients during the haematopoietic stem cell transplantation for the treatment of high risk leukaemia. TK therapy allows to eliminate the post-transplant immunosuppression treatment thus accelerating the immune reconstitution and controlling the immunological consequences arising from the genetic differences with the donor, known as Graft versus Host Disease (GvHD). In virtue of this approach, HSCT from partially compatible donors is a safer and more effective option, thus potentially increasing the number of candidates for transplantation.

TK008 study TK008 is a pivotal randomised Phase III trial (TK008) in adult patients affected by high-risk leukaemia undergoing transplant of haematopoietic stem cells collected from partially compatible (haploidentical) family donors. The trial design has disease-free survival as the primary end-point – which includes both transplant-related mortality and disease relapse – evaluated on a patient population of 170 patients. The trial will compare the outcome of haplo-transplants with or without TK add-backs, with a 3:1 randomisation ratio in favour of the TK arm. Secondary end-points include overall survival, reduction of transplant-related mortality, safety and patients’ quality of life. With the aim to provide additional clinical benefit to patients and to significantly increase the potential participation of centres in the trial, the Company implemented in 2012 two important changes in the protocol design of Phase III trial TK008. The first consists in broadening the enrolment criteria to include patients in leukaemic relapse, in addition to those in disease remission; the second change provides for the introduction of a further treatment option in the control arm, based on the use of an unmanipulated transplant followed by cyclophosphamide administration during the post-transplantation period.

SOURCE: MolMed.com

#MolMed #TK #Conditional Marketing Authorisation #Molmed TK

MolMed TK therapy submitted for Conditional Marketing Authorisation in EU

MolMed S.p.A. (Milan:MLM) announces that the Company has filed to the European Medicines Agency an application for Conditional Marketing Authorisation for TK, its novel investigational cell-gene therapy. TK is an adjunctive treatment in hematopoietic stem cell transplantation (HSCT) for patients affected by high risk leukaemia.

It is estimated that in EU approximately 5,000 leukaemia patients/year lack a fully compatible donor: TK offers to these patients the option of transplantation from a mismatched donor without post-transplant immunosuppression. If approved, TK would be the first cell-gene therapy product on the market for this life threatening condition. The Conditional Marketing Authorisation application is supported by cumulative efficacy and safety results obtained from a completed Phase I-II, multicentre trial (TK007). These data were included in presentations given at the 49th annual congress of the American Society of Clinical Oncology (ASCO) and at the 55th Annual Meeting of the American Society of Hematology (ASH) in 2013. Results show that TK can reduce transplant-related mortality and increase overall survival in high risk leukaemia patients transplanted from a mismatched HSCT donor. The application also includes initial data from the currently ongoing pivotal randomised Phase III study (TK008), which have been submitted to the next ASCO congress taking place in May in Chicago. The TK therapy was granted Orphan Drug Designation by the European Commission.

Claudio Bordignon, Chairman of the Board and CEO of MolMed, commented: ”With the submission of the Conditional Marketing Authorisation, we have achieved an important milestone which represents a turning point in the clinical development of our TK technology. We believe that by providing fast immune reconstitution and eliminating the need for post-transplant immune-suppression, TK may represent a new and powerful tool able to provide an efficacious treatment option for those high risk leukaemia patients who lack a fully matched donor. With more than 120 patients treated worldwide and an ongoing randomised Phase III trial, our efforts in the implementation of the TK technology witnesses our dedication to the treatment of leukaemia patients lacking a valid treatment option, and MolMed competitiveness in the challenging field of immune-gene therapy of cancer”.

the risk-benefit balance of the medicinal product is positive;

it is likely that the applicant will be in a position to provide the comprehensive clinical data;

unmet medical needs will be fulfilled;

the benefit to public health of the immediate availability on the market of the medicinal product concerned outweighs the risk inherent in the fact that additional data are still required.

TK008 study TK008 is a pivotal randomised Phase III trial (TK008) in adult patients affected by high-risk leukaemia undergoing transplant of haematopoietic stem cells collected from partially compatible (haploidentical) family donors. The trial design has disease-free survival as the primary end-point – which includes both transplant-related mortality and disease relapse – evaluated on a patient population of 170 patients. The trial will compare the outcome of haplo-transplants with or without TK add-backs, with a 3:1 randomisation ratio in favour of the TK arm. Secondary end-points include overall survival, reduction of transplant-related mortality, safety and patients’ quality of life. With the aim to provide additional clinical benefit to patients and to significantly increase the potential participation of centres in the trial, the Company implemented in 2012 two important changes in the protocol design of Phase III trial TK008. The first consists in broadening the enrolment criteria to include patients in leukaemic relapse, in addition to those in disease remission; the second change provides for the introduction of a further treatment option in the control arm, based on the use of an unmanipulated transplant followed by cyclophosphamide administration during the post-transplantation period.

SOURCE: MolMed.com

#MolMed #TK #Conditional Marketing Authorisation

MolMed Approved The Interim Financial Report At 30 September 2013

The Board of Directors of MolMed S.p.A., chaired by Prof. Claudio Bordignon, today reviewed and approved the interim financial report at 30 September 2013. The most important elements were: TK: expansion in the US of the pivotal Phase III trial for high-risk leukaemia patients; NGR-TNF: continuation of the clinical development program; the increase of revenues to € 3.1 million from development of new cell and gene therapy treatments for third parties.

Milan (Italy), 11 November 2013 – The Board of Directors of MolMed S.p.A. (MLM.MI), chaired by Prof. Claudio Bordignon, today reviewed and approved the interim financial report at 30 September 2013. The most important elements were:

TK: expansion in the US of the pivotal Phase III trial (TK008) for high-risk leukaemia patients;

NGR-hTNF: continuation of the clinical development program, in particular with the achievement of new statistically significant results on the increase in overall survival of patients treated weekly with low doses NGR-hTNF in combination with doxorubicin in the randomised Phase II study in soft tissues sarcomas;

The increase of revenues to € 3.1 million (+11.9% compared to the first 9 months 2012) from development of new cell and gene therapy treatments for third parties.

Claudio Bordignon, Chairman of the Board and CEO of MolMed, commented: “Consistently with the first half of 2013, the last quarter was characterized by important confirmation on the potential of both our investigational antitumoral therapeutics: TK and NGR-hTNF. As far as TK is concerned, the expansion of the Phase III clinical study in the United States opens a new important frontier for the company, with an important sign of interest by prestigious American clinical centers participating in the study. With regard to NGR- hTNF, the analysis of the randomized Phase II trial of NGR -hTNF in soft tissue sarcomas showed – in addition to what was already observed last year in terms of progression-free survival – a statistically significant increase in overall survival for those patients included in the arm treated with the 0.8 µg/sqm dose of NGR-hTNF administered weekly in combination with doxorubicin. These results confirm the previously observed effectiveness of NGR-hTNF in various cancer indications and validate the choice of the low doses administered weekly utilized in the treatment of malignant pleural mesothelioma currently in Phase III, with results expected between December 2013 and January 2014. The activities in development and production of cell and gene therapies confirmed the leadership of the Company is playing at an international level is confirmed by the results obtained in this field and by the constant increase in revenues”.

Highlights of financial data Key income statements

Key achievements in the first nine months of 2013 Research & Clinical Development activities

In the first nine months of 2013, the Company’s activities focused mainly on clinical development of its two investigational anticancer therapeutics: TK for the treatment of high-risk leukaemia and NGR-hTNF for the treatment of a number of solid tumours.

TK main achievements include:

expansion in the US of the pivotal Phase III trial (TK008) of its proprietary TK cell therapy for high-risk leukaemia patients. The study, already ongoing in Europe, foresees patient enrolment in 16 clinical centres in Europe, United States and Israel;

presentation at ASCO 2013 and at the BMT Tandem Meetings 2013 of positive long-term safety and efficacy data with its cell therapy product TK for the treatment of hematologic malignancies with bone marrow transplantation from partially matched (haplo-identical) donors. The seven year follow-up analysis of this large patient population indicates that overall and disease-free survivals from haploidentical family donors are fully comparable to those obtained from fully matched donors;

progress on dossier preparation in order to file for a market authorisation application for TK through a special procedure (Conditional Marketing Authorisation) with the European Medicines Agency. This request is based on the rarity of the indication (TK has obtained Orphan Drug designation), the favourable risk/benefit ratio and the demonstration of safety and clinical efficacy obtained in more than 120 patients treated so far. The Company expects to file this request with the European authority in 2013.

NGR-hTNF main achievements include:

presentation at the European Cancer Congress 2013 (ECCO-ESMO-ESTRO) of new data showing a statistically significant doubling of the median survival – associated with a favourable tolerability profile – of patients treated weekly with low doses NGR-hTNF in combination with doxorubicin in the randomised Phase II study in soft tissues sarcomas;

completion of patient enrolment in a randomised Phase II trial in platinum-resistant/refractory ovarian cancer patients. Results of the study are expected in the first half of 2014;

presentation at ASCO of positive results from a randomized Phase II study evaluating safety and efficacy of its investigational drug NGR-hTNF in combination with standard chemotherapy for the first-line therapy of non-small cell lung cancer (NSCLC) patients with squamous histology. The addition of NGR-hTNF to standard chemotherapy induced a two-fold higher tumour shrinkage and, most importantly, a statistically significant 50% reduction in the risk of death compared to chemotherapy alone (p=0.04). Notably, these efficacy outcomes were coupled with a favourable tolerability profile.

Development and GMP production for third parties

Development and production of new cell and gene therapy treatments for third parties are consolidating the company’s technological leadership in this field, and are also generating a significant increase in revenues (as described in the Comments to financials). During the first nine months of 2013, activities continued under two major agreements signed in 2011, respectively with Telethon Foundation and GlaxoSmithKline, for the development and production of investigational gene therapies for a total of seven rare diseases. Furthermore, the GMP production facility has been upgraded and optimized. Of particular relevance is the publication of results obtained by the Telethon Foundation concerning two of the gene therapies for which MolMed develops and manufactures viral vectors and transduces patients hematopoietic stem cell, on July 11th in Science, one of the most internationally renowned scientific journals.

Comments to financials First nine months of 2013

Revenues in the first nine months of 2013, amounting to € 3.4 million, increased by 11.3% compared to the first nine months of 2012. This increase is due to the intensification in the development and GMP production activities for third parties. The abovementioned activities generated revenues of € 3.1 million compared to € 2.8 million in the corresponding period of 2012, with an increase of 11.9% respect to the first nine months of last year. Other revenues related to public funding for research and development activities, for € 308 thousand, showed an increase compared to the same period of 2012.

Operating costs for the first nine months of 2013 totaled € 17.9 million and show a decrease of € 2.2 million respect to the first nine months of 2012 (€ 20.1 million). The decrease of 10.9% in operating costs is mainly due to a reduction of services costs.

The operating loss for the first nine months of 2013, of € 14.5 million, has been reduced by 14.9% respect to the same figure of the previous year of € 17.0 million.

Financial results are negative for € 170 thousand, decreasing from € 450 thousand respect to the first nine months of 2012. Financial income, for € 143 thousand (€ 682 thousand at 30 September, 2012) is primarily derived from the management of the Company’s cash through temporary, low-risk investments. The decrease of such income in the period is mainly due to the progressive reduction of financial resources due to the absorption of liquidity for ordinary business and to lower rates of return of the market. Financial costs, € 313 thousand in the first nine months of 2013, are mainly due to the pro solute of VAT receivables transaction finalized in the second quarter of 2013.

The result for the first nine months of 2013 show a loss of € 14.7 million, compared to a loss of € 16.7 million in the corresponding period of 2012.

Third quarter of 2013

In the third quarter of 2013, operating revenues totalled € 685 thousand, compared to € 639 thousand in the third quarter of 2012. Operating revenues include € 613 thousand in revenues from development and production for third parties, higher, in this quarter, respect to the same period last year, due above all to development and GMP production activities for third parties.

Operating revenues also consist of € 72 thousand in other income, related to public funding for research and development activities in line with the same period of 2012.

In the third quarter of 2013, operating costs amounted to € 5.1 million, respect to € 6.6 million in the third quarter of 2012. This downward trend is mainly due to a decrease in services costs compared to the concentration of costs sustained in the last three quarters of 2012 for the development of NGR015 and to costs related to pivotal Phase III trial, for which patient enrolment was completed at the end of 2012.

The operating result for the third quarter of 2012 was negative for € 4.4 million, compared to a loss of € 6.0 million in the same period of 2012.

In the third quarter of 2013 result of financial management is negative for € 24 thousand. The negative result is mainly due to financial costs related to the VAT receivables pro solute transaction finalized in the first half of 2013.

The result for the third quarter of 2013 shows a loss of € 4.5 million, respect to a loss of € 6.0 million in the corresponding period of 2012.

Net financial position

The net financial position at 30 September 2013 amounts to € 10.0 million, and includes cash and cash equivalents for € 12.0 million, financial debt related to the accounting of financial leasing for laboratory equipment for € 33 thousand and long term financial debts for € 2.0 million related to the recording of the pro solute transaction of VAT receivables.

It is relevant to note that the Shareholders, members of the shareholders’ agreement, who previously communicated their availability to support the Company in carrying out its industrial and development plans until 31 August 2014, for a total amount of €4.3 million, on 11 November 2013 have communicated their availability to extend their commitment up to, but not beyond, 30 November 2014 and limited to a total amount of €7.1 million.

The official Corporate Financial Reporting Manager of MolMed S.p.A., Andrea Quaglino, herewith attests, pursuant to Article 154-bis, paragraph 2 of the Italian Consolidated Law on Finance (Legislative Decree 58/1998), that the accounting disclosure contained in this press release matches documentary evidence, corporate books, and accounting records. In this press release, use is made of “alternative performance indicators” which are not provided for under European IFRS, and whose significance and content – in line with Recommendation CESR/05-178b published on 3 November 2005 – are illustrated below:

Operating Result: defined as the difference between sales revenues and other income and costs for materials, costs of services received, costs for use of third-party assets, personnel costs and amortisation, depreciation & write downs. It represents the profit before financial flows and taxes;

Net Financial Position: is the algebraic sum of cash, cash equivalents, financial receivables and other financial assets, and current and non-current financial debt.

Financial statements at 30 September 2013 Income statement

Statement of comprehensive income

Net financial position

FONTE: MolMed.com

#MolMed #Claudio Bordignon #MolMed interim financial report 2013

Il Consiglio di Amministrazione di MolMed S.p.A., riunitosi oggi sotto la presidenza del Professor Claudio Bordignon, ha esaminato ed approvato il resoconto intermedio di gestione al 30 settembre 2013. Gli elementi più salienti sono stati: TK:espansione negli Stati Uniti dello studio registrativo di Fase III per il trattamento delle leucemie ad alto rischio; NGR-hTNF: prosecuzione del programma di studi clinici; aumento dei ricavi a € 3,1 milioni dall’attività conto terzi riguardante lo sviluppo di nuovi trattamenti di terapia genica e cellulare.

Milano, 11 novembre 2013 – Il Consiglio di Amministrazione di MolMed S.p.A. (MLM.MI), riunitosi oggi sotto la presidenza del Professor Claudio Bordignon, ha esaminato ed approvato il resoconto intermedio di gestione al 30 settembre 2013. Gli elementi più salienti sono stati:

TK: espansione negli Stati Uniti dello studio registrativo di Fase III (TK008) per il trattamento delle leucemie ad alto rischio;

NGR-hTNF: prosecuzione del programma di studi clinici, in particolare l’ottenimento di risultati statisticamente significativi sull’aumento della sopravvivenza nei pazienti trattati con basse dosi di NGR-hTNF in combinazione con doxorubicina nello studio randomizzato di Fase II nei sarcomi dei tessuti molli;

L’aumento dei ricavi a € 3,1 milioni (+11,9% rispetto ai primi 9 mesi 2012) dall’attività conto terzi riguardante lo sviluppo di nuovi trattamenti di terapia genica e cellulare.

Claudio Bordignon, Presidente ed Amministratore Delegato di MolMed, commenta: “In linea con quanto evidenziato nella relazione del primo semestre del 2013, questi ultimi tre mesi sono stati segnati da importanti conferme circa il potenziale dei nostri due prodotti antitumorali sperimentali: TK ed NGR-hTNF. Per quanto riguarda TK, l’espansione dello studio clinico di Fase III negli Stati Uniti apre una nuova e importante frontiera per la Società, con importanti segnali di interesse da parte di prestigiosi centri americani che hanno aderito allo studio.

Per quanto riguarda NGR-hTNF, l’analisi dello studio randomizzato di Fase II di NGR-hTNF nei sarcomi dei tessuti molli ha mostrato – in aggiunta a quanto osservato lo scorso anno sulla sopravvivenza libera da progressione di malattia – un incremento statisticamente significativo della sopravvivenza globale dei pazienti inclusi nel braccio con trattamento con dose settimanale di 0,8 µg/m2 somministrata in combinazione con doxorubicina. Questi risultati confermano l’efficacia di NGR-hTNF già osservata in precedenza in svariate indicazioni neoplastiche e avvalorano la scelta di una somministrazione settimanale a basse dosi già utilizzata nel trattamento del mesotelioma pleurico maligno attualmente in Fase III, i cui risultati sono attesi tra dicembre 2013 e gennaio 2014.

L’attività della Società nello sviluppo e produzione di terapie geniche e cellulari ha confermato, in questo periodo, una leadership avvalorata dai risultati ottenuti in questo settore e dall’aumento costante dei ricavi”.

Sintesi dei dati economici e finanziari Dati di conto economico

Principali risultati ottenuti nei primi nove mesi del 2013 Attività di Ricerca e Sviluppo Clinico

Nel corso dei primi nove mesi del 2013, le attività della Società si sono concentrate soprattutto sullo sviluppo clinico dei due prodotti antitumorali sperimentali: TK per il trattamento delle leucemie acute ad alto rischio e NGR-hTNF per il trattamento di diversi tipi di tumori solidi.

Per quanto riguarda TK, i principali progressi compiuti comprendono:

l’espansione negli Stati Uniti dello studio clinico registrativo di Fase III (TK008) della terapia genica con cellule TK in pazienti affetti da leucemie ad alto rischio. Lo studio, già in corso in Europa, prevede di arruolare pazienti in 16 centri clinici in Europa, Stati Uniti e Israele;

la presentazione ad ASCO 2013 ed al BMT Tandem Meetings 2013 di nuovi dati positivi di efficacia e sicurezza a lungo termine sulla terapia cellulare TK per il trattamento di neoplasie ematologiche con trapianto di midollo osseo da donatori parzialmente compatibili (aploidentici). L'analisi di follow-up a sette anni di questa popolazione di pazienti indica che la sopravvivenza globale e quella libera da malattia ottenuti da donatori familiari aploidentici sono del tutto comparabili a quelli ottenuti da donatori interamente compatibili;

il proseguimento delle attività relative alla preparazione del dossier per la richiesta di autorizzazione all’immissione in commercio attraverso una procedura particolare (Conditional Marketing Authorisation) presso l’ente regolatorio europeo. Questa richiesta si basa sulla rarità dell’indicazione (TK ha ottenuto la designazione di Medicinale Orfano), sul favorevole rapporto rischio/beneficio e sulla dimostrazione di sicurezza ed efficacia clinica ottenuta su più di 120 pazienti trattati ad oggi. La Società stima di poter presentare questa richiesta alle autorità Europee nel corso del 2013.

Per quanto riguarda NGR-hTNF, i principali progressi compiuti comprendono:

presentazione allo European Cancer Congress (ECCO-ESMO-ESTRO) di nuovi dati che evidenziano un raddoppio statisticamente significativo della durata mediana di sopravvivenza - associata ad un favorevole profilo di tollerabilità – in pazienti trattati con basse dosi di NGR-hTNF in combinazione con doxorubicina nello studio randomizzato di Fase II nei sarcomi dei tessuti molli. Di notevole rilevanza è l’evidenza che efficacia e tollerabilità sono risultate simili oltre che in pazienti non pretrattati anche in pazienti resistenti a precedenti trattamenti;

il completamento dell'arruolamento dei pazienti nello studio randomizzato di Fase II per il trattamento del carcinoma dell’ovaio resistente o refrattario al platino con NGR-hTNF. I risultati finali di tale studio sono attesi nella prima metà del 2014;

presentazione ad ASCO 2013 di risultati positivi di uno studio randomizzato di Fase II volto a valutare efficacia e tollerabilità del suo farmaco sperimentale NGR-hTNF in combinazione con chemioterapia standard nella terapia di prima linea di pazienti con carcinoma polmonare ad istologia squamosa. L'aggiunta di NGR-hTNF alla chemioterapia standard ha, infatti, indotto una riduzione più che doppia della massa tumorale e, soprattutto, un riduzione statisticamente significativa del 50% del rischio di decesso rispetto alla sola chemioterapia (p=0,04). Da rilevare che questi risultati di efficacia sono associati ad un profilo di tollerabilità particolarmente favorevole.

Sviluppo e produzione GMP conto terzi Le attività di sviluppo e produzione di nuovi trattamenti di terapia genica e cellulare svolte conto terzi stanno consolidando la leadership tecnologica della Società in quest’ambito e generando un significativo incremento dei ricavi (come illustrato nei commenti ai dati finanziari). Nel corso dei primi nove mesi del 2013 sono proseguite le attività previste dai due importanti accordi stipulati nel 2011, rispettivamente con Fondazione Telethon e GlaxoSmithKline, per lo sviluppo e la produzione di terapie geniche sperimentali per un totale di sette malattie rare. Inoltre, sono stati eseguiti lavori di adeguamento ed ottimizzazione dell’impianto di produzione GMP.

Di particolare rilievo la pubblicazione avvenuta l’11 luglio su una delle maggiori riviste scientifiche mondiali – Science – dei risultati ottenuti da Fondazione Telethon su due delle terapie geniche per le quali MolMed ha svolto e continua a svolgere attività di sviluppo e produzione dei vettori virali e trasduzione delle cellule staminali ematopoietiche dei pazienti.

Commento ai dati economici e finanziari Primi nove mesi 2013 - dati economici

I ricavi operativi dei primi nove mesi 2013, pari a € 3,4 milioni, registrano un aumento di 11,3% rispetto ai primi nove mesi 2012, grazie, soprattutto, all’intensificazione delle attività di sviluppo e produzione GMP svolte conto terzi. Attività che hanno generato ricavi per € 3,1 milioni contro € 2,8 milioni nello stesso periodo del 2012, con un aumento del 11,9% rispetto ai primi nove mesi del precedente esercizio. Gli altri proventi, pari a € 308 migliaia, derivano principalmente da attività svolte nell’ambito di progetti di finanza agevolata e risultano in aumento rispetto ai primi nove mesi del 2012.

I costi operativi dei primi nove mesi 2013 ammontano complessivamente a € 17,9 milioni e presentano un decremento per € 2,2 milioni rispetto ai primi nove mesi del 2012 (€ 20,1 milioni), per una percentuale pari al 10,9% dei costi operativi, è principalmente dovuto al decremento dei costi per servizi.

Il risultato operativo dei primi nove mesi 2013, negativo per € 14,5 milioni, risulta essere migliorato di una percentuale pari al 14,9% rispetto a quello del corrispondente periodo del precedente esercizio, negativo per € 17,0 milioni.

Il risultato della gestione finanziaria risulta essere negativo per un importo pari a € 170 migliaia, diminuendo di Euro 450 migliaia rispetto ai primi nove mesi 2012. I proventi finanziari, pari a € 143 migliaia (€ 682 migliaia al 30 settembre 2012) derivano principalmente dalla gestione delle disponibilità liquide della Società attraverso investimenti temporanei a basso profilo di rischio. Il decremento registrato nel periodo è principalmente dovuto alla progressiva riduzione delle disponibilità finanziarie per l’assorbimento di liquidità derivante dalla gestione ordinaria, nonché al netto decremento dei tassi di rendimento di mercato. Gli oneri finanziari, pari a € 313 migliaia nei primi nove mesi 2013, sono principalmente legati al costo dell’operazione di cessione pro soluto di crediti IVA perfezionatasi nel corso del secondo trimestre 2013.

Il risultato dei primi nove mesi 2013 evidenzia una perdita di € 14,7 milioni, rispetto ad una perdita di € 16,7 milioni registrata nel corrispondente periodo del precedente esercizio.

Terzo trimestre 2013 - dati economici

Nel terzo trimestre 2013 i ricavi operativi risultano essere complessivamente pari a € 685 migliaia, rispetto a € 639 migliaia nel terzo trimestre 2012. I ricavi operativi sono composti per € 613 migliaia da attività di sviluppo e produzione conto terzi, il cui andamento è superiore rispetto allo stesso periodo del precedente esercizio grazie, soprattutto, alle attività di produzione e sviluppo GMP svolte conto terzi.

I ricavi operativi sono inoltre costituiti, per € 72 migliaia, da proventi da attività svolte nell’ambito di progetti di finanza agevolata e sono in linea rispetto al corrispondente periodo del 2012.

Nel terzo trimestre 2013 i costi operativi risultano essere pari a € 5,1 milioni, rispetto a € 6,6 milioni nel terzo trimestre 2012. Tale andamento riflette principalmente una diminuzione dei costi per servizi a causa della forte concentrazione negli ultimi tre trimestri del precedente esercizio dei costi legati alla sperimentazione di fase III del prodotto NGR015, il cui arruolamento si è concluso alla fine del 2012.

Il risultato operativo del terzo trimestre 2013 è negativo per € 4,4 milioni, a fronte di un risultato negativo per € 6,0 migliaia nel corrispondente periodo 2012. Nel terzo trimestre 2013 il risultato della gestione finanziaria risulta essere negativo per € 24 migliaia. Il risultato negativo è principalmente legato al costo finanziario derivante dall’operazione di cessione pro soluto crediti IVA perfezionatasi nel corso del primo semestre 2013.

Il risultato nel terzo trimestre 2013, evidenzia una perdita di € 4,5 milioni, rispetto ad una perdita di € 6,0 milioni registrata nel corrispondente periodo dell’esercizio 2012.

Posizione finanziaria netta

La posizione finanziaria netta al 30 settembre 2013, positiva per € 10,0 milioni, risulta composta da liquidità per € 12,0 milioni, da debiti finanziari legati alla contabilizzazione di leasing finanziari su attrezzature di laboratorio per € 33 migliaia e da debiti finanziari non correnti per € 2,0 milioni, questi ultimi legati alla contabilizzazione dell’operazione di cessione pro soluto di crediti IVA.

Si segnala inoltre che in data 11 novembre 2013 i Soci aderenti al patto che avevano già manifestato la disponibilità a sostenere la Società nell’attuazione dei piani di sviluppo e industriali sino al 31 agosto 2014 per un complessivo importo di € 4,3 milioni, hanno comunicato la volontà di estendere il predetto impegno sino e non oltre la data del 30 novembre 2014 e fino al maggior complessivo importo di € 7,1 milioni.

Il Dirigente Preposto alla redazione dei documenti contabili societari di MolMed S.p.A., Andrea Quaglino, attesta, ai sensi dell’art. 154-bis, comma 2 del Testo Unico della Finanza (D. Lgs. 58/1998), che l’informativa contabile contenuta nel presente comunicato corrisponde alle risultanze documentali, ai libri e alle scritture contabili.

Nel presente comunicato vengono utilizzati alcuni “indicatori alternativi di performance” non previsti dai principi contabili IFRS-EU, il cui significato e contenuto, in linea con la raccomandazione CESR/05-178b pubblicata il 3 novembre 2005, sono illustrati di seguito:

Risultato Operativo: definito come la differenza tra i ricavi e gli altri proventi ed i costi relativi al consumo di materiali, al costo per servizi, al costo per godimento di beni di terzi, al costo del personale e agli ammortamenti e svalutazioni. Rappresenta il margine realizzato ante gestione finanziaria ed imposte.

Posizione Finanziaria Netta: rappresenta la somma algebrica tra disponibilità liquide e mezzi equivalenti, crediti finanziari e altre attività finanziarie e debiti finanziari correnti e non correnti.

Prospetti contabili al 30 settembre 2013 Conto economico

Conto economico complessivo

(*)A seguito dell’adozione, a partire dal 1° gennaio 2013, in modo retrospettivo dell’emendamento allo IAS 19 – Benefici ai dipendenti, i valori del conto economico relativo ai primi nove mesi 2012 e della situazione patrimoniale-finanziaria al 31 dicembre 2012 sono stati rideterminati coerentemente. Per ulteriori informazioni circa il relativo impatto, si rinvia al paragrafo Principi contabili, emendamenti ed interpretazioni applicati dal 1° gennaio 2013 delle Note illustrative del presente Resoconto intermedio di gestione

Posizione finanziaria netta

FONTE: MolMed.com

#MolMed #Claudio Bordignon

MolMed expands in the United States the Phase III trial of TK for the treatment of high-risk leukaemia

MolMed announces the enrolment of the first patient in the United States, initiating the cross-Atlantic expansion of the pivotal Phase III trial (TK008) of its proprietary TK cell/gene therapy for high-risk leukaemia patients. The study, already ongoing in Europe, foresees patient enrolment in 16 clinical centres worldwide. Claudio Bordignon, Chairman of the Board and CEO ofMolMed, commented: “The treatment with TK cells of this first US patient opens new frontiers to the dissemination of MolMed’s technology”.

MolMed S.p.A. (MLM.MI) announces the enrolment of the first patient in the United States, initiating the cross-Atlantic expansion of the pivotal Phase III trial (TK008) of its proprietary TK cell/gene therapy for high-risk leukaemia patients.

The study, already ongoing in Europe, foresees patient enrolment in 16 clinical centres worldwide.

Based on cumulative efficacy and safety data and on the Orphan Drug designation, the Company expects to file a request for Conditional Marketing Approval of TK with the European Medicine Agency in 2013, and subsequent extension in the US.

Claudio Bordignon, Chairman of the Board and CEO of MolMed, commented: “The treatment with TK cells of this first US patient opens new frontiers to the dissemination of MolMed’s technology. A technology that offers an original and relevant contribution to the solution of the problem of identifying a donor for each high risk leukaemia patient candidate for bone marrow transplantation”.

About TK TK is a cell therapy product, based on the use of genetically engineered donor T cells carrying a “suicide gene”. These cells are administered to patients during the haematopoietic stem cell transplantation for the treatment of high-risk leukaemia. TK therapy allows to avoid the need for post-transplant immunosuppression, thus accelerating the immune reconstitution and controlling the immunological consequences arising from the genetic disparity with the donor, known as Graft versus Host Disease (GvHD).

About Phase III trial TK008 TK008 is a pivotal randomised Phase III trial in adult patients affected by high-risk leukaemia undergoing transplant of haematopoietic stem cells collected from partially compatible (haploidentical) family donors. The trial design has disease-free survival as the primary end-point -which includes both transplant-related mortality and disease relapse – evaluated on a patient population of 170 patients. The trial will compare the outcome of haplo-transplants with or without TK add-backs, with a 3:1 randomisation ratio in favour of the TK arm. Secondary end-points include overall survival, reduction of transplant-related mortality, safety and patients’ quality of life.

With the aim to provide additional clinical benefit to patients and to significantly increase the potential participation of centres in the trial, the Company implemented in 2012 two important changes in the protocol design of Phase III trial TK008. The first consists in broadening the enrolment criteria to include patients in leukaemic relapse, in addition to those in disease remission; the second change introduces a further treatment option in the control arm, based on the use of an unmanipulated transplant followed by cyclophosphamide administration during the post-transplantation period.

About MolMed MolMed S.p.A. is a biotechnology company focused on research, development and clinical validation of novel anticancer therapies. MolMed’s pipeline includes two antitumour therapeutics in clinical development: TK, a cell-based therapy enabling bone marrow transplants from partially compatible donors, in absence of post-transplant immune-suppression, in Phase III in high-risk acute leukaemia; NGR-hTNF, a novel vascular targeting agent, in Phase III in malignant pleural mesothelioma and in Phase II in six more indications: colorectal, lung (small-cell and non-small-cell), liver and ovarian cancer, and soft tissue sarcomas. MolMed also offers top-level expertise in cell and gene therapy to third parties to develop, conduct and validate projects from preclinical to Phase III trials, including scale-up and cGMP production of clinical-grade viral vectors, and manufacturing of patient-specific genetically engineered cells.MolMed is headquartered at the San Raffaele Biomedical Science Park in Milan, Italy. The Company’s shares are listed on the main market (MTA) of the Milan Stock Exchange. (Ticker Reuters: MLMD.MI)

FONTE: MolMed.com

#MolMed Phase III TK #Phase III TK United States #MolMed leukaemia United States

MolMed annuncia l’arruolamento del primo paziente negli Stati Uniti dando inizio all’espansione cross-Atlantica dello studio clinico registrativo di Fase III (TK008) della terapia genica con cellule TK in pazienti affetti da leucemie ad alto rischio. Lo studio, già in corso in Europa, prevede di arruolare pazienti in 16 centri clinici in Europa, Stati Uniti e Israele. Claudio Bordignon, Presidente ed Amministratore Delegato di MolMed, commenta: “Il trattamento con cellule TK del primo paziente negli Stati Uniti apre una nuova frontiera per la diffusione della tecnologia di MolMed”.

MolMed S.p.A. (MLM.MI) annuncia l’arruolamento del primo paziente negli Stati Uniti dando inizio all’espansione cross-Atlantica dello studio clinico registrativo di Fase III (TK008) della terapia genica con cellule TK in pazienti affetti da leucemie ad alto rischio.

Lo studio, già in corso in Europa, prevede di arruolare pazienti in 16 centri clinici in Europa, Stati Uniti e Israele.

Sulla base dei dati cumulativi di efficacia, di sicurezza e grazie alla designazione di Farmaco Orfano, la Società prevede di presentare la richiesta per la Conditional Marketing Approval per TK all’European Medicine Agency nel 2013, con successiva estensione negli USA.

Claudio Bordignon, Presidente ed Amministratore Delegato di MolMed, commenta: “Il trattamento con cellule TK del primo paziente negli Stati Uniti apre una nuova frontiera per la diffusione della tecnologia di MolMed. Una tecnologia che porta un contributo importante ed originale alla soluzione del problema della difficoltà di identificare un donatore per ogni paziente candidato al trapianto di midollo per le forme più gravi di leucemia acuta”.

TK TK è una terapia cellulare, basata sull’impiego di linfociti T geneticamente modificati in cui è stato inserito un “gene suicida”. Queste cellule vengono utilizzate in associazione al trapianto di cellule staminali ematopoietiche per il trattamento di leucemie ad alto rischio. La terapia TK permette così di eliminare l’immunosoppressione post trapianto accelerando la ricostituzione immunitaria e controllando le conseguenze immunologiche della disparità genetica con il donatore, definite come malattia del trapianto contro l’ospite (GvHD).

Lo studio di Fase III TK008 TK008 è uno studio registrativo randomizzato di Fase III su pazienti adulti affetti da leucemie ad alto rischio sottoposti a trapianto di cellule staminali emopoietiche da donatore familiare parzialmente compatibile (aploidentico). Il disegno dello studio ha come obiettivo primario la sopravvivenza libera da malattia - che include sia la mortalità dovuta al trapianto, sia le recidive leucemiche - valutata su una popolazione complessiva di 170 pazienti. Lo studio confronterà i risultati ottenuti dall’aplo-trapianto associato o meno all’impiego di TK, con un rapporto di randomizzazione di 3 a 1 a favore dell’impiego di TK. Gli obiettivi secondari includono la sopravvivenza globale, la riduzione della mortalità dovuta all’aplo-trapianto, il profilo di sicurezza e la qualità della vita dei pazienti.

Nell'ottica di offrire un ulteriore beneficio clinico ai pazienti e di aumentare sensibilmente il potenziale di adesione dei centri allo studio, la Società ha apportato nel 2012 due importanti modifiche nel disegno sperimentale del protocollo dello studio di Fase III. La prima consiste nell’allargamento dell’indicazione ai pazienti con recidiva leucemica, che si aggiungono a quelli con remissione di malattia; la seconda prevede l’inserimento nel braccio di controllo di un’ulteriore opzione terapeutica, basata sull’impiego del trapianto non manipolato seguito dalla somministrazione di ciclofosfamide nel periodo post-trapianto.

FONTE: MolMed.com

#MolMed Fase III TK #Fase III TK Stati Uniti

MolMed NGR-hTNF: new data at the European Cancer Congress

MolMed, new data presented at the European Cancer Congress show a statistically significant increase in survival of patients suffering from soft tissue sarcomas treated with NGR-hTNF.

MolMed S.p.A. (MLM.MI) presented at the European Cancer Congress 2013 (ECCO-ESMO-ESTRO), in Amsterdam (The Netherlands), additional data from an ongoing randomized Phase II study evaluating safety and efficacy of its investigational drug NGR-hTNF on patients suffering from soft tissue sarcomas. Data show the impact of the weekly administration of NGR-hTNF at low doses (0,8μg/sqm) in combination with doxorubicin.

Presentation: “NGR-hTNF given at low dose or high dose with or without doxorubicin in soft-tissue sarcomas”

The new data highlighted a statistically significant doubling of the median survival associated to a favourable tolerability profile. Of particular interest is the evidence that efficacy and tolerability were similar both in patients untreated or resistant to prior treatments.

Claudio Bordignon, Chairman and CEO of MolMed, commented: “These additional results from a randomised Phase II study are relevant for two reasons: on the one hand they confirm the previously observed effectiveness of NGR-hTNF in various cancer indications; on the other hand they validate the choice of the weekly schedule of low doses administration, as already demonstrated in the treatment of malignant pleural mesothelioma, currently in Phase III clinical trial”.

Randomized Phase II study of NGR-hTNF in soft tissue sarcomas

This four-arm trial was designed to select the best NGR-hTNF regimen for patients with sarcomas. The primary aim of achieving a doubled three-month progression-free rate (40% vs 20%) was met by the combination of low-dose intensified NGR-hTNF (0.8 μg/sqm weekly) with doxorubicin, after both the first and the second trial stages.

Preliminary data presented in June at the 49th annual meeting of the American Society of Clinical Oncology (ASCO) also show that the superiority of this regimen over the other ones in terms of progression-free survival (with a three-fold increased median duration) translated into an analogous advantage in terms of overall survival (with a two-fold increased median time).

About NGR-hTNF

NGR-hTNF is a novel therapeutic agent for solid tumours which displays antitumor activity through its specific binding to blood vessels feeding the tumour mass. NGR-hTNF is being investigated in a large clinical program, including Phase II trials in six indications: colorectal, lung (small-cell and non-small-cell), liver and ovarian cancer, and soft tissue sarcomas and a pivotal Phase III trial in malignant pleural mesothelioma: based on the trial follow-up evolution, results are now expected to be available between December 2013 and January 2014.

About MolMed MolMed S.p.A. is a biotechnology company focused on research, development and clinical validation of novel anticancer therapies. MolMed’s pipeline includes two antitumour therapeutics in clinical development: TK, a cell-based therapy enabling bone marrow transplants from partially compatible donors, in absence of post-transplant immune-suppression, in Phase III in high-risk acute leukaemia; NGR-hTNF, a novel vascular targeting agent, in Phase III in malignant pleural mesothelioma and in Phase II in six more indications: colorectal, lung (small-cell and non-small-cell), liver and ovarian cancer, and soft tissue sarcomas. MolMed also offers top-level expertise in cell and gene therapy to third parties to develop, conduct and validate projects from preclinical to Phase III trials, including scale-up and cGMP production of clinical-grade viral vectors, and manufacturing of patient-specific genetically engineered cells.MolMed is headquartered at the San Raffaele Biomedical Science Park in Milan, Italy. The Company’s shares are listed on the main market (MTA) of the Milan Stock Exchange. (Ticker Reuters: MLMD.MI)

FONTE: MolMed.com

#MolMed #MolMed NGR-hTNF #MolMed sarcoma #MolMed European Cancer Congress

European Cancer Congress, MolMed on efficacy of drug NGR-hTNF

MolMed S.p.A. will present further data on the efficacy of the investigational drug NGR-hTNF in soft tissues sarcomas tomorrow at the European Cancer Congress.

MolMed S.p.A. (MLM.MI) will present further data on the efficacy of its investigational drug NGR-hTNF in combination with doxorubicin in soft tissue sarcomas, tomorrow at the European Cancer Congress 2013 (ECCO-ESMO-ESTRO) taking place in Amsterdam (The Netherlands) from September 27th to October 1st 2013.

Dr Emanuela Palmerini from the Istituto ortopedico Rizzoli (Bologna) will give an oral presentation titled “NGR-hTNF given at low dose or high dose with or without doxorubicin in soft-tissue sarcomas” at 9:12 of Tuesday, October the 1st 2013 in the section “Sarcomas: soft tissues and bones”.

New data disclosed at the congress will be announced in separate press releases during the meeting.

Randomized Phase II study of NGR-hTNF in soft tissue sarcomas

About NGR-hTNF

FONTE: MolMed.com

#MolMed #MolMed European Cancer Congress #MolMed NGR-hTNF #MolMed soft tissues sarcomas

MolMed, nuovi dati presentati allo European Cancer Congress mostrano un aumento statisticamente significativo della sopravvivenza in pazienti affetti da sarcoma trattati con NGR-hTNF.

MolMed S.p.A. (MLM.MI) ha presentato allo European Cancer Congress 2013 (ECCO-ESMO-ESTRO), in corso ad Amsterdam (Olanda), dati ulteriori sull’efficacia del proprio farmaco sperimentale NGR-hTNF in uno studio randomizzato di Fase II internazionale, attualmente in corso in pazienti affetti da sarcomi dei tessuti molli. I dati mostrano l’impatto del trattamento settimanale con NGR-hTNF a basse dosi (0,8μg/m2) in combinazione con doxorubicina.

Presentazione: “Due dosi di NGR-hTNF somministrato da solo o in combinazione con doxorubicina nei sarcomi dei tessuti molli”

I nuovi dati presentati hanno evidenziato un raddoppiamento statisticamente significativo della durata mediana di sopravvivenza, associata ad un favorevole profilo di tollerabilità. Di notevole rilevanza è l’evidenza che efficacia e tollerabilità sono risultate simili sia in pazienti non pretrattati che resistenti a precedenti trattamenti.

Claudio Bordignon, Presidente ed Amministratore Delegato di MolMed, commenta: “Questi risultati addizionali ottenuti in uno studio randomizzato di Fase II sono per noi di particolare importanza per un duplice motivo: da una parte confermano l’efficacia di NGR-hTNF già osservata in precedenza in svariate indicazioni neoplastiche; dall’altra parte avvalorano la scelta di una somministrazione settimanale a basse dosi, come già dimostrato nel trattamento del mesotelioma pleurico maligno che si trova attualmente in studio clinico di Fase III”.

Studio randomizzato di Fase II di NGR-hTNF nei sarcomi dei tessuti molli

Questo studio a quattro-bracci è stato disegnato per selezionare il migliore regime terapeutico di NGR-hTNF per i pazienti affetti da sarcoma. L'obiettivo primario di raddoppiare il tasso di sopravvivenza a tre mesi senza progressione di malattia (40% vs 20%) è stato raggiunto dalla combinazione di basse dosi intensificate di NGR-hTNF (trattamento settimanale con 0,8 μg/m2) con la doxorubicina, sia nel primo sia nel secondo stadio dello studio.

Dati preliminari mostrati a giugno al 49° convegno annuale dell’American Society of Clinical Oncology (ASCO) mostrano inoltre che la superiorità in termini di sopravvivenza libera da malattia (con un aumento della durata media di tre volte) di questo regime rispetto agli altri si è tradotta in un analogo vantaggio in termini di sopravvivenza globale (con un aumento della durata media di due volte).

NGR-Htnf

NGR-hTNF è un nuovo agente terapeutico per i tumori solidi che mostra un'attività antitumorale attraverso il suo legame specifico con i vasi sanguigni che alimentano la massa tumorale. NGR-hTNF è oggetto di un largo programma di sviluppo clinico, che comprende sei studi di Fase II nei tumori del colon-retto, del polmone (a piccole cellule e non a piccole cellule), del fegato e dell’ovaio, e nei sarcomi dei tessuti molli ed uno studio registrativo di Fase III nel mesotelioma pleurico maligno, i cui risultati, sulla base dell’evoluzione del follow-up dello studio, sono ora previsti essere disponibili tra dicembre 2013 e gennaio 2014.

FONTE: MolMed.com

#MolMed #MolMed sarcoma #MolMed European Cancer Congress

MolMed S.p.A. presenterÃ ulteriori dati sullâefficacia del farmaco sperimentale NGR-hTNF nei sarcomi dei tessuti molli domani allo European Cancer Congress. MolMed S.p.A. (MLM.MI) presenterÃ domani allo European Cancer Congress 2013 (ECCO-ESMO-ESTRO), in corso ad Amsterdam (Olanda) dal 27 settembre al 1 ottobre 2013, dati ulteriori sullâefficacia del proprio farmaco sperimentale NGR-hTNF in combinazione con la [...]

MolMed S.p.A. presenterà ulteriori dati sull’efficacia del farmaco sperimentale NGR-hTNF nei sarcomi dei tessuti molli domani allo European Cancer Congress.

MolMed S.p.A. (MLM.MI) presenterà domani allo European Cancer Congress 2013 (ECCO-ESMO-ESTRO), in corso ad Amsterdam (Olanda) dal 27 settembre al 1 ottobre 2013, dati ulteriori sull’efficacia del proprio farmaco sperimentale NGR-hTNF in combinazione con la doxorubicina nei sarcomi dei tessuti molli.

La Dr.ssa Emanuela Palmerini dell’istituto ortopedico Rizzoli di Bologna farà una presentazione orale dal titolo “Due dosi di NGR-hTNF somministrato da solo o in combinazione con doxorubicina nei sarcomi dei tessuti molli” alle ore 9:12 di Martedì 1 ottobre 2013, durante la sessione “Sarcomi: tessuti moli e ossa”.

Nuovi dati presentati durante il convegno saranno oggetto di comunicati successivi, rilasciati a margine del convegno stesso.

Studio randomizzato di Fase II di NGR-hTNF nei sarcomi dei tessuti molli

Questo studio a quattro-bracci è stato disegnato per selezionare il migliore regime terapeutico di NGR-hTNF per i pazienti affetti da sarcoma. L'obiettivo primario di raddoppiare il tasso di sopravvivenza a tre mesi senza progressione di malattia (40% vs 20%) è stato raggiunto dalla combinazione di basse dosi intensificate di NGR-hTNF (trattamento settimanale con 0,8 μg/m 2) con la doxorubicina, sia nel primo sia nel secondo stadio dello studio.

Dati preliminari mostrati a giugno al 49° convegno annuale della American Society of Clinical Oncology (ASCO) mostrano inoltre che la superiorità in termini di sopravvivenza libera da malattia (con un aumento della durata media di tre volte) di questo regime rispetto agli altri si è tradotta in un analogo vantaggio in termini di sopravvivenza globale (con un aumento della durata media di due volte).

NGR-hTNF

NGR-hTNF è un nuovo agente terapeutico per i tumori solidi che mostra un'attività antitumorale attraverso il suo legame specifico con i vasi sanguigni che alimentano la massa tumorale. NGR-hTNF è oggetto di in un largo programma di sviluppo clinico, che comprende uno studio di Fase III nel mesotelioma pleurico maligno e sei studi di Fase II nei tumori del colon-retto, del polmone (a piccole cellule e non a piccole cellule), del fegato e dell’ovaio, e nei sarcomi dei tessuti molli.

FONTE: MolMed.com

#MolMed #MolMed European Cancer Congress

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