Malignant pleural mesothelioma (MPM) is a form of cancer that is almost always caused by repeated exposition to asbestos fibers. With an incidence of approximately 1/100,000, MPM is still a relatively rare type of cancer, but has been progressing fast in the past 20 years as incidence rates have continuosly increased. MPM has a long latency period of the disease, and symptoms are non-specific, so that in most cases diagnosis is difficult before the advanced stage of the disease is reached. Treatment of malignant mesothelioma using conventional therapies has not proven to be successful, and patients have a median survival time of 6-12 months after disease presentation.
“Orphan Drug designation for our investigational new drug NGR-hTNF in mesothelioma both in the EU and in the U.S. confirms the very interesting early efficacy and safety results achieved in an ongoing Phase II trial conducted in Italy, and presented in June at the ASCO Annual meeting 2008”, says Claudio Bordignon, MolMed’s Chairman and CEO. “These preliminary study results already gave evidence of substantial clinical benefits in terms of long-lasting disease control and promising survivals in chemo-pretreated mesothelioma patients, particularly in terms of improved overall survival, and with nearly doubled progression-free survival with respect to best supportive care data reported in literature. Consolidated results of the trial will be available in December, and I am convinced they will open the way to the full clinical development of ARENEGYR in mesothelioma”.
About Orphan Drug designation Orphan Drug designation is granted to therapeutics intended for treatment of life-threatening or chronically debilitating pathologies affecting a small patient population (no more than 5 in 10,000 people), and for which there are either no or only unsatisfactory treatment options. Orphan Drug designation confers several benefits to drug development including, upon drug authorisation, marketing exclusivity for a period of 7 years in the U.S., and of 10 years in th EU.
About NGR-hTNF NGR-hTNF (ARENEGYR) 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) selectively binding tumour blood vessels, fused to the powerful human anticancer cytokine TNF. The resulting molecule has unique biological properties, including induction of tumour vascular permeability and normalisation, and a direct biological antitumour activity. NGR-hTNF is undergoing clinical development both as single agent and in combination with several different chemotherapeutic agents: currently, in addition to mesothelioma and colorectal cancer, single agent Phase II trials are ongoing in hepatocellular carcinoma and small-cell lung cancer; for colorectal cancer, it is also being tested in a Phase II trial in combination with Xelox. Also ongoing is a Phase I trial in combination with cisplatin, while a Phase I trial in combination with doxorubicin was successfully completed.
About MolMed 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 two more novel therapeutics in clinical development: TK, a cell-based therapy enabling bone marrow transplant from partially compatible donors, in Phase III in high-risk acute leukaemias; and M3TK, a therapeutic vaccine, in Phase I/II in advanced melanoma. MolMed’s clinical pipeline is supported by a broad portfolio of therapeutic candidates. MolMed is headquartered at the San Raffaele Biomedical Science Park in Milan, Italy. The company’s shares (MLM) are listed at the Standard segment (class I) of the MTA managed by Borsa Italiana
For further information, please contact: Holger Neecke Director Business Development - Investor Relator MolMed S.p.A. phone: +39 02 21277.205 fax: +39 02 21277.325 e-mail: investor.relations@molmed.com Elena Lungagnani Communication Manager MolMed S.p.A. phone: +39 02 21277.207 fax: +39 02 21277.325 e-mail: media.relations@molmed.com
