Arenegyr granted orphan drug designation

The European Commission has granted Arenegyr, MolMed’s new mesothelioma drug “orphan” designation. The Orphan designation is granted to drugs which are intended to be used in the treatment of life-threatening or chronic conditions which affect no more than five in ten thousand people. Designating Arenegyr as an Orphan drug means it may be possible to reduce the drug’s development time and make it available on the market more quickly. The MolMed biotech company focuses on research and development of new anti-tumor therapy. Arenegyr is one a new class of anti-cancer drug called a “vascular targeting agent.” These types of drugs selectively target the vascular system of tumors, and prevent cancer cells from receiving vital blood, oxygen, and nutrients. Arenegyr is currently undergoing clinical trials both as a single chemotherapy agent and in combination with different drugs. The new chemotherapy drug is being trialed for colorectal cancer as well as mesothelioma treatment. Malignant plural mesothelioma is a type of cancer which develops in the lining of the lungs as a result of exposure to asbestos. The cancer is relatively rare but highly lethal, as the cancer is both aggressive and resistant to treatment. MolMed has said that their preliminary results show that Arenegyr has demonstrated both safety and efficacy, has promising survival rates, and may provide substantial clinical benefit. In addition, the drug appears to have low toxicity. In the company’s malignant plural mesothelioma trial, Arenegyr was tested as a second line therapy in patients who had received prior chemotherapy treatment. MolMed’s results show overall improved survival rates, and almost doubled progression-free survival rates. The company has also trialed Arenegyr for the treatment of colorectal cancer, which has a variety of different causes, one of which is known to be asbestos exposure. Colorectal cancer is the third most common cancer in the world, with one million new cases diagnosed every year, and is the second most common cause of cancer deaths in the Western world. Most patients with advanced colorectal cancer develop resistance to commonly-used therapies, and there is therefore a strong need for new treatments. MolMed’s colorectal cancer study included 43 patients, all of whom had received other types of prior treatments which had all failed. MolMed claims the preliminary data shows a fifty percent relative improved overall survival rate. Chairman and Chief Executive Officer of MolMed Claudio Bordignon said of European Commission’s decision, “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…” (Source: Asbestos and Mesothelioma News)