On August 5, 2019 Progenics Pharmaceuticals, Inc. (NASDAQ:PGNX), an oncology company developing innovative targeted medicines and artificial intelligence to find, fight and follow cancer, reported that it has completed enrollment five months ahead of schedule in the Company’s Phase 3 CONDOR study evaluating the diagnostic performance and clinical impact of PyLTM (18F-DCFPyL) in men with biochemical recurrence of prostate cancer (Press release, Progenics Pharmaceuticals, AUG 5, 2019, View Source [SID1234538165]). PyL is the Company’s PSMA-targeted small molecule PET/CT imaging agent designed to visualize prostate cancer.

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The Company also reported that it recently met with the U.S. Food and Drug Administration (FDA) to discuss the regulatory path for PyL. Based on those discussions, the Company believes that positive data from the CONDOR study and the previously reported OSPREY study could serve as the basis for a regulatory submission. Progenics intends to submit a New Drug Application (NDA) with the FDA for PyL following the Phase 3 CONDOR study, assuming positive results.

"We have made significant progress with our PyL program in recent months on both the clinical and regulatory fronts, demonstrating our ability to execute complex, multi-center studies under ambitious timelines," said Vivien Wong, Ph.D., Executive Vice President, R&D, of Progenics. "The accelerated enrollment completion in our Phase 3 CONDOR study underscores the clinical interest in our PSMA-targeted imaging agent and the need for better diagnostic options for patients with biochemical recurrent prostate cancer."

Dr. Wong continued, "We believe that PyL has the potential to alter physician treatment plans and improve patient outcomes through the detection of small nodal and metastatic lesions that are missed by currently available conventional imaging modalities. Currently, over 1,000 men with prostate cancer have been imaged with PyL in the clinical setting. We look forward to rapidly advancing this program toward NDA submission and commercialization following positive CONDOR data. We are grateful to the patients and their caregivers who participated in the trial, and to the investigators and their study staff for their extraordinary efforts in executing this study ahead of schedule."

The Phase 3 CONDOR study is a multi-center, open label study that dosed 208 patients with biochemical recurrence of prostate cancer at 14 sites in the United States and Canada. The primary endpoint is based on positive predictive value and will assess the correct localization rate (CLR), defined as a percentage of subjects with a one-to-one correspondence between localization of at least one lesion identified by PyL and the composite truth standard. Secondary measures include the percentage of subjects with a change in intended prostate cancer treatment plans due to PyL PET/CT imaging.

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 initiated patient dosing of the Phase 3 study evaluating the diagnostic performance and clinical impact of PyL in November 2018. The last patient visit is expected in September and top-line data is expected by year end.

PyL and 1095

The multicenter, randomized, open-label, controlled Phase 2 clinical study is evaluating the efficacy and safety of I-131-1095 in combination with enzalutamide compared to enzalutamide alone in patients with mCRPC who are PSMA-avid, chemotherapy naïve, and progressed on abiraterone. PSMA-avidity is determined utilizing PyL imaging which enrich for patients who are most likely to respond to 1095 therapy, highlighting the synergistic potential of our PSMA-targeted pipeline to better diagnose and treat prostate cancer. Based on the early data from this open-label study and dialogue with the FDA, we plan to evaluate initiating a pivotal trial of 1095 in 2020.

About Prostate Cancer

Prostate cancer is the second most common form of cancer affecting men in the United States: an estimated one in nine men will be diagnosed with prostate cancer in his lifetime. The American Cancer Society estimates that each year approximately 174,650 new cases of prostate cancer will be diagnosed and about 31,620 men will die of the disease. Approximately 2.9 million men in the U.S. currently count themselves among prostate cancer survivors.