Progenics Relaunches Registrational Trial Of Azedra To Treat Pheochromocytomas

(RTTNews) - Progenics Pharmaceuticals Inc. (PGNX) announced Monday that it is resuming a phase 2b 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.

Azedra originally was developed by Progenics' Molecular Insight Pharmaceuticals or MIP subsidiary, which commenced the phase 2b study under a 2009 Special Protocol Assessment (SPA) with the United States Food and Drug Administration or FDA. The compound also has Orphan Drug and Fast Track designations, which are intended to get important new therapies to patients sooner by expediting the review of drugs for serious conditions filling unmet medical needs.

In late 2010 Molecular Insight Pharmaceuticals suspended the trial, with enrollment two-thirds complete, to seek additional funding. Progenics, which acquired MIP in early 2013, plans for patient recruitment to continue after making drug supply manufacturing arrangements for the trial.

Following a successful completion of this phase 2b study, Progenics said it intends to submit a New Drug Application or NDA and request priority review to receive FDA action on the application within six months instead of the standard ten.

Pheochromocytomas, which form in the adrenal glands, are a form of paragangliomas, rare neuroendocrine tumors that form in nerve tissue in the adrenal glands and near certain blood vessels and nerves. Pheochromocytomas and paragangliomas can be benign (not cancerous) or malignant (cancerous). Existing options for these tumors, including surgery, radiation, chemotherapy, ablation, embolization and targeted therapeutic agents, can fail to result in effective disease treatment, the company said.