Progenics Pharmaceuticals Relaunching Registrational Trial of Azedra to Treat
To Resume Enrollment Under Special Protocol Assessment in Clinical Study of
Novel Ultra-Orphan Therapy
TARRYTOWN, N.Y., Nov. 25, 2013 (GLOBE NEWSWIRE) -- 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."
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.
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
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CONTACT: Kathleen Fredriksen
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