Italian biotechnology company MolMed has recently announced that ARENEGYR, its experimental anti-cancer drug that is being investigated for the treatment of mesothelioma and a number of other cancers, has been granted orphan drug status from the US FDA. This announcement follows on a similar designation given by the EU’s pharmaceutical regulatory agency in June. Orphan drug status is available to investigational treatment agents that focus on uncommon and/or rare diseases, specifically defined as pathologies that affect less than 5 in 10,000 people, and it confers a number of benefits to the manufacturer to reward their research.

Malignant pleural mesothelioma remains a very difficult disease to treat effectively. Even though contemporary multimodal treatment protocols have increased median survival time, the disease is still not curable, so research into more effective therapeutics continues on a number of fronts. ARENEGYR represents one of the most promising avenues of contemporary research. It is a vascular targeting agent that selectively targets and binds with a tumor’s blood vessels. Its mechanism of action is governed by two major elements: NGR, a “tumor homing peptide” that allows this binding to occur, and TNF, a cytokine known for its ability to trigger apoptosis, which is the principal mechanism for ARENEGYR’s antitumor activity.

Along with its proposed use for mesothelioma treatment, ARENEGYR is being investigated in single agent therapy for the treatment of colorectal cancer, hepatocellular carcinoma and small-cell lung cancer. Molmed is also exploring ARENEGYR in combination with cisplatin for mesothelioma treatment and with Xelox for colorectal cancer.

Labels: chemotherapy, mesothelioma, pleuralmesothelioma, treatments