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Progenics Pharmaceuticals Completes Enrollment of Phase 2/3 Clinical Trial of PSMA-Targeted PET/CT Imaging Agent PyL™ in Prostate Cancer
Top-line Data Expected in 4Q2018
NEW YORK, June 26, 2018 (GLOBE NEWSWIRE) -- Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX), an oncology company developing innovative medicines and imaging technology for targeting and treating cancer, today announced that it has completed enrollment in its Phase 2/3 OSPREY clinical trial evaluating the diagnostic accuracy of its PSMA-targeted PET/CT imaging agent, PyL™ (18F-DCFPyL), in prostate cancer.
"The completion of enrollment for our PyL trial, ahead of schedule, marks an important milestone for the advancement of our PSMA-targeted pipeline," said Mark Baker, Chief Executive Officer of Progenics. “PyL is a PSMA-targeted PET imaging agent that has the potential to transform how physicians manage and treat prostate cancer from time of initial diagnosis to metastatic or recurrent disease; it has the potential to detect very small bone and soft tissue metastases at earlier stages in the disease progression. We look forward to reporting top-line data from the trial in the fourth quarter of 2018 while initiating a second Phase 3 study of PyL in patients with biochemical recurrence of prostate cancer by year end.”
The OSPREY study enrolled 266 patients with localized high risk prostate cancer and 117 patients with recurrent or metastatic disease in the United States and Canada for a total of 383 patients. The study’s co-primary endpoints include the assessment of sensitivity and specificity of PyL PET/CT imaging to detect prostate cancer in regional lymph nodes in patients scheduled to undergo radical prostatectomy. Secondary endpoints include sensitivity within sites of metastasis or recurrence, and other diagnostic performance characteristics, pharmacokinetic parameters, and safety and tolerability.
About PyL™ for PET Imaging of Prostate Cancer
PyL (also known as [18F]DCFPyL) is a fluorinated PSMA-targeted Positron Emission Topography (“PET”) imaging agent that enables visualization of both bone and soft tissue metastases to determine the presence or absence of recurrent and/or metastatic prostate cancer.
Progenics develops innovative medicines and other technologies to target and treat cancer. Progenics' pipeline includes: 1) therapeutic agents designed to precisely target cancer (AZEDRA®, 1095, and PSMA TTC), 2) PSMA-targeted imaging agents for prostate cancer (1404 and PyL™), and 3) imaging analysis technology. Progenics' first commercial product, RELISTOR® (methylnaltrexone bromide) for opioid-induced constipation, is partnered with Valeant Pharmaceuticals International, Inc.
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