Friday it was announced the European Commission has granted orphan drug status for Arenegyr, an anti-tumor therapeutic drug manufactured by MolMed S.p.A. in the treatment of malignant pleural mesothelioma (MPM).

According to PharmaLive, Arenegyr is a vascular targeting agent with a unique mode of action, and a first-in-class compound in the class of peptide/cytokine complexes able to selectively target the tumor vasculature. Unique biological properties include induction of tumor vascular permeability and normalization, and a direct biological anti-tumor activity.

PharmaLive quotes MolMed’s president and CEO, Claudio Bordignon, as saying, “Orphan drug designation for Arenegyr in mesothelioma represents a fundamental acknowledgement of the interesting early efficacy and safety results achieved in an ongoing Phase II trial, with 53 patients recruited so far, and which we just presented at the ASCO (American Society of Clinical Oncology) Annual meeting 2008.

He went on to say, “The analysis of preliminary study results presented at ASCO, conducted on 41 patients, already gave evidence of substantial clinical benefits in terms of long-lasting disease control and promising survivals in chemo-pretreated mesothelioma patients. In particular, it shows improved overall survival, and nearly doubled progression-free survival with respect to best supportive care data reported in literature.”

Bordignon said consolidated results relating to survival data will be available in December.

Tags: American Society of Clinical Oncology, Arenegyr, ASCO, Claudio Bordignon, meso, mesothelioma, MolMed, orphan drug, pleural mesothelioma

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