US FDA Grants Orphan Status to Mesothelioma Drug

A new drug – MolMed’s NGR-hTNF (trade name Arenegyr)- has been granted orphan status by the United States Food and Drug Administration for the treatment of the rare cancer, mesothelioma . It already received the same designation in June of 2008 from the European Union. Orphan drugs are those which treat rare diseases whose sufferers have few or no other options. The orphan status allows for the manufacturer to exclusively market the drug for seven years in the United States and 10 years in the European Union, providing an incentive for drugmakers to produce these pharmaceuticals despite the small market for them. Mesothelioma is a cancerous growth affecting the membrane of the lungs – the mesothelium. The disease almost always results from inhaled asbestos fibers, particles, or dust. Asbestos was once a popular construction material, used in everything from ceiling tiles to insulation.

Decontamination of buildings which had used asbestos is an ongoing problem to this day. While the absolute numbers have been low, incidences of mesothelioma have been increasing over the last few years. This phenomenon is likely due to patients who were exposed to asbestos years ago finally developing the disease. Unlike many other diseases, it can take decades after exposure before a patient manifests symptoms of mesothelioma. This makes pinpointing the exact source of the asbestos exposure difficult. Current therapies for mesothelioma – radiation, chemotherapy, and surgery – have largely proven ineffective. The life expectancy after a malignant pleural mesothelioma diagnosis is only 6 to 12 months. The orphan status was granted to NGR-hTNF after it demonstrated a record of safety and efficiency during its Phase II trials. Finalized results of those trials is expected in December of 2008, but initial findings show that when it us used in patients who have also been treated with chemotherapy, survival rates improve and disease progression is controlled. The drug is designed to destroy tumors in the mesothelium, thereby killing the cancer. The drug is also currently undergoing Phase I testing as a combination with other drugs to treat other forms of cancer.