To Resume Enrollment Under Special Protocol Assessment in Clinical Study of Novel Ultra-Orphan Therapy
TARRYTOWN, NY, USA I November 25, 2013 I Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX) today announced 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.
Daniel Pryma, M.D., 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, 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 Progenics’ Molecular Insight Pharmaceuticals (MIP) subsidiary, which commenced the phase 2b study under a 2009 Special Protocol Assessment (SPA) with the United States Food and Drug Administration (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 MIP 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 intends to submit a New Drug Application (NDA) and request priority review to receive FDA action on the application within six months instead of the standard ten.
Hagop Youssoufian, M.Sc., M.D., Executive Vice President of Research and Development for Progenics, said, “Azedra has the potential to be the first approved treatment for pheochromocytomas. Our team is energized by this opportunity to potentially bring a treatment option with improved dosing, safety and efficacy to patients suffering with these devastating conditions.”
About Azedra
Azedra is a radiotherapy candidate with FDA Fast Track status in a phase 2b registrational trial for pheochromocytomas and paragangliomas. Azedra is in development under a Special Protocol Assessment with the U.S. Food and Drug Administration using a surrogate marker registrational endpoint. In addition to potentially treating pheochromocytomas and paragangliomas, Azedra may also have utility in treating neuroblastomas and other neuroendocrine diseases.
About Pheochromocytoma and Paragangliomas
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.
About Progenics
Progenics Pharmaceuticals, Inc. is developing innovative medicines for oncology, with a pipeline that includes several product candidates in late-stage clinical development. Progenics’ first-in-class PSMA targeted technology platform includes an antibody drug conjugate therapeutic and a small molecule targeted imaging agent, both in phase 2 clinical trials. Among other assets in its pipeline of targeted radiotherapy and molecular imaging compounds is Azedra™, an ultra-orphan radiotherapy candidate also in a phase 2 study under an SPA. Progenics’ first commercial product, Relistor® (methylnaltrexone bromide) for opioid-induced constipation, is partnered with and marketed by Salix Pharmaceuticals, Inc. Ono Pharmaceutical Co. has licensed subcutaneous Relistor in Japan. For additional information, please visit www.progenics.com.
SOURCE: Progenics Pharmaceuticals
Post Views: 144
To Resume Enrollment Under Special Protocol Assessment in Clinical Study of Novel Ultra-Orphan Therapy
TARRYTOWN, NY, USA I November 25, 2013 I Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX) today announced 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.
Daniel Pryma, M.D., 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, 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 Progenics’ Molecular Insight Pharmaceuticals (MIP) subsidiary, which commenced the phase 2b study under a 2009 Special Protocol Assessment (SPA) with the United States Food and Drug Administration (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 MIP 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 intends to submit a New Drug Application (NDA) and request priority review to receive FDA action on the application within six months instead of the standard ten.
Hagop Youssoufian, M.Sc., M.D., Executive Vice President of Research and Development for Progenics, said, “Azedra has the potential to be the first approved treatment for pheochromocytomas. Our team is energized by this opportunity to potentially bring a treatment option with improved dosing, safety and efficacy to patients suffering with these devastating conditions.”
About Azedra
Azedra is a radiotherapy candidate with FDA Fast Track status in a phase 2b registrational trial for pheochromocytomas and paragangliomas. Azedra is in development under a Special Protocol Assessment with the U.S. Food and Drug Administration using a surrogate marker registrational endpoint. In addition to potentially treating pheochromocytomas and paragangliomas, Azedra may also have utility in treating neuroblastomas and other neuroendocrine diseases.
About Pheochromocytoma and Paragangliomas
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.
About Progenics
Progenics Pharmaceuticals, Inc. is developing innovative medicines for oncology, with a pipeline that includes several product candidates in late-stage clinical development. Progenics’ first-in-class PSMA targeted technology platform includes an antibody drug conjugate therapeutic and a small molecule targeted imaging agent, both in phase 2 clinical trials. Among other assets in its pipeline of targeted radiotherapy and molecular imaging compounds is Azedra™, an ultra-orphan radiotherapy candidate also in a phase 2 study under an SPA. Progenics’ first commercial product, Relistor® (methylnaltrexone bromide) for opioid-induced constipation, is partnered with and marketed by Salix Pharmaceuticals, Inc. Ono Pharmaceutical Co. has licensed subcutaneous Relistor in Japan. For additional information, please visit www.progenics.com.
SOURCE: Progenics Pharmaceuticals
Post Views: 144
