Progenics Pharmaceuticals Has Completed Enrollment in Clinical Trial for Azedra

Progenics Pharmaceuticals, Inc. (NASDAQ:PGNX) has completed enrollment for its Phase 2b clinical trial for Azedra, an ultra-orphan radiotherapeutic candidate for the treatment of malignant or recurrent pheochromocytoma and paraganglioma.
According to the press release:

Progenics will allow enrollment to continue through the end of December so that patients already identified as potential candidates may have the opportunity to participate in the trial. The Company expects to report top-line data in the second half of 2016.

“Achieving the number of enrolled patients required under the SPA is a major milestone for Progenics and the Azedra program, a novel therapeutic candidate that has the potential to be the first approved therapy in the U.S. for the treatment of malignant or recurrent pheochromocytoma and paraganglioma,” said Mark Baker, Chief Executive Officer of Progenics. “The trial, if positive, will provide the basis for a regulatory submission to the FDA, and we look forward to building on the impressive data reported to date as we advance Azedra as a treatment option for these very rare and life threatening tumors.”

The open-label trial is designed to evaluate the efficacy and safety of the administration of two therapeutic doses of Azedra in patients with malignant relapsed/refractory pheochromocytoma or paraganglioma, ultra-orphan cancers with limited treatment options. The primary objective of the study is to determine the clinical benefit of Azedra based on the proportion of study participants with a reduction of all antihypertensive medication by at least 50% for at least six months. The SPA requires that 25% of 58 evaluable patients achieve the primary endpoint.

Click here to read the full press release.