Progenics relaunches registrational trial of Azedra in pheochromocytomas

USA-based Progenics Pharmaceuticals (Nasdaq: PGNX) says it is resuming a Phase IIb clinical study of safety and efficacy of a novel targeted radiotherapy, Azedra, in patients suffering from pheochromocytomas. Existing options for these rare endocrine tumors that form in the adrenal glands can fail to result in effective disease treatment, the company noted.

Daniel Pryma, assistant professor of radiology and nuclear medicine/molecular imaging modality chief of the Department of Radiology at the University of Pennsylvania Perelman School of Medicine, and lead investigator in the trial, quoted by Progenics, said: "I have seen in my own research evidence that Azedra is a promising agent for the treatment of metastatic pheochromocytoma and paraganglioma - two orphan oncology indications with tragically unmet needs. There currently are no medications approved specifically to treat pheochromocytomas and paragangliomas."

Azedra originally was developed by Molecular Insight Pharmaceuticals (MIP), acquired by Progenics this year (The Pharma Letter January 23), which commenced the Phase IIb study under a 2009 Special Protocol Assessment (SPA) with the US Food and Drug Administration.