MILAN, ITALY--(Marketwire -10/25/11)- MolMed S.p.A. (Milan: MLM.MI - News) announces the expansion in the United States of a pivotal Phase III trial of its investigational anticancer drug NGR-hTNF in malignant pleural mesothelioma, with treatment of the first patient at one of the most prestigious US Universities in New York. The trial is already ongoing in in Europe and plans to involve more than 40 centres worldwide. Results from the trial are expected in 2013. The start of Phase III in the US follows IND clearance from the FDA.
Claudio Bordignon, MolMed's chairman and CEO, comments: "We are very satisfied with the progress of patient recruitment in this pivotal trial, now involving some of the most important clinical centres in both Europe and the United States. This expansion is a very important step in the clinical development plan of NGR-hTNF, which could provide a new therapeutic option for patients affected by malignant mesothelioma, a severe form of cancer linked to the exposure to asbestos, for which NGR-hTNF has been granted Orphan Drug Designation in the European Union and in the United States. The trial is intended to assess the clinical efficacy of our investigational drug as second-line treatment for patients progressing after chemotherapy with pemetrexed, the only approved drug currently available for this indication."
About Phase III trial NGR015
NGR015 is a pivotal randomised, double-blind, placebo-controlled, multicentre Phase III trial, expecting to enrol 390 adult patients affected by malignant pleural mesothelioma with disease progressing after standard pemetrexed-based chemotherapy. The primary study endpoint is overall survival. Secondary endpoints include progression-free survival, disease control rate, safety and patients' quality of life.
The trial investigates the administration of either NGR-hTNF or placebo in addition to the best investigator's choice (BIC), i.e. supportive care alone or combined with one chemotherapeutic agent (either doxorubicin, or gemcitabine, or vinorelbine). Randomisation ratio is 1:1. NGR-hTNF or placebo are administered intravenously as 1-hour infusion at 0.8 micrograms/m2 once a week, until disease progression. Supportive care is delivered according to institutional and literature guidelines and chemotherapy is administered as per standard clinical practice. (Trial identifier on ClinicalTrials.gov: NCT01098266)
This press release is written in compliance with public disclosure obligations established by CONSOB (Italian securities & exchange commission) resolution no. 11971 of 14.5.1999, as subsequently amended.
NGR-hTNF is a vascular targeting agent with unique mode of action, and a first-in-class compound in the class of peptide/cytokine complexes able to selectively target the tumour vasculature. It consists of a tumour homing peptide (NGR) that selectively binds tumour blood vessels, fused to the human cytokine TNF. NGR-hTNF is undergoing clinical development both as monotherapy and in combination therapy, in a total of seven indications. Currently ongoing randomised trials of NGR-hTNF include a Phase III trial in mesothelioma and four Phase II trials for non-small-cell lung cancer, soft tissue sarcomas, ovarian cancer and mesothelioma as first-line maintenance therapy. Other Phase II trials of NGR-hTNF include completed trials in mesothelioma, in liver cancer, in colorectal cancer, in small-cell lung cancer and in ovarian cancer. NGR-hTNF has been granted Orphan Drug designation for the treatment of mesothelioma and of liver cancer in both the EU and the US.
MolMed S.p.A. is a biotechnology company focused on research, development and clinical validation of novel antitumour therapies. In addition to NGR-hTNF, MolMed's pipeline includes another anticancer therapeutic in clinical development, TK - a cell-based therapy enabling bone marrow transplants from partially compatible donors - in Phase III in high-risk leukaemias. MolMed is headquartered at the San Raffaele Biomedical Science Park in Milan, Italy. The company's shares are listed on the Milan Stock Exchange, at the Standard segment (class I) of the MTA managed by Borsa Italiana.
This press release may contain certain forward-looking statements. Although the company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, including scientific, business, economic and financial factors, which could cause actual results to differ materially from those anticipated in the forward-looking statements. The company assumes no responsibility to update forward-looking statements or adapt them to future events or developments. This document does not constitute an offer or invitation to subscribe or purchase any securities of MolMed S.p.A.