On January 2, 2018 Progenics Pharmaceuticals, Inc. (NASDAQ:PGNX), an oncology company developing innovative medicines and imaging analytical tools for targeting and treating cancer, reported that it has completed enrollment in its Phase 3 study of 1404, a PSMA-targeted small molecule SPECT/CT imaging agent that is designed to visualize prostate cancer (Press release, Progenics Pharmaceuticals, JAN 2, 2018, View Source [SID1234522901]).
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"The results of this large-scale Phase 3 study will provide important insights on the potential of our novel imaging agent to accurately and non-invasively detect and monitor patients with low-grade prostate cancer," said Mark Baker, Chief Executive Officer of Progenics. "We believe that 1404 has the possibility to transform the practice of active surveillance, and we look forward to providing top-line results in the third quarter."
The Phase 3 study enrolled approximately 450 patients in the U.S. and Canada with newly-diagnosed or low-grade prostate cancer, whose biopsy indicates a histopathologic Gleason grade of ≤ 3+4 severity and/or are candidates for active surveillance. The study was designed to evaluate the specificity of 1404 imaging to identify patients without clinically significant prostate cancer and sensitivity to identify patients with clinically significant disease.
About 1404, an Imaging Compound Targeting Prostate Specific Membrane Antigen
Progenics’ molecular imaging radiopharmaceutical product candidate 1404 targets the extracellular domain of prostate specific membrane antigen (PSMA), a protein amplified on the surface of > 95% of prostate cancer cells and a validated target for the detection of primary and metastatic prostate cancer. 1404 is labeled with Technetium-99m, a gamma-emitting isotope that is widely available, is easy to prepare, and is attractive for nuclear medicine imaging applications. The image created provides the opportunity to visualize cancer, potentially allowing for improved detection and staging, more precise biopsies, and a targeted treatment plan including active surveillance as a disease management tool.
About Prostate Cancer
Prostate cancer is the second most common form of cancer affecting men in the United States: an estimated one in seven men will be diagnosed with prostate cancer in his lifetime. The American Cancer Society estimates that each year approximately 161,360 new cases of prostate cancer will be diagnosed and about 26,730 men will die of the disease. Approximately 2.9 million men in the U.S. currently count themselves among prostate cancer survivors.