On March 24, 2017 Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX), an oncology company developing innovative medicines and other products for targeting and treating cancer, reported the publication of previously-reported results from the Phase 2 study of 1404 in the online edition of the Journal of Nuclear Medicine (Press release, Progenics Pharmaceuticals, MAR 24, 2017, View Source [SID1234518266]). 1404 is a PSMA-targeted small molecule SPECT/CT imaging agent that is designed to visualize prostate cancer.

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The data published today reviews previously reported data demonstrating the sensitivity of 1404 to detect prostate cancer using both visual and semi-quantitative tumor to background (TBR) scores. The uptake within the prostate gland evaluated by both visual and TBR scores correlated significantly with Gleason Score.

"The results from this study highlight the potential for 1404 to better assess the stage and extent of a patient’s prostate cancer versus biopsy," stated Professor Karolien Goffin, M.D., Ph.D., University Hospitals Leuven, author of the publication. "Importantly, 1404 may be used as a surrogate marker for Gleason Score, and could be used to evaluate lymph node involvement in patients with intermediate and high risk prostate cancer, which signals disease that has spread beyond the prostate. The data provide a strong rationale for continued development of 1404."

Progenics is currently evaluating 1404 in a Phase 3 study. The study is enrolling patients with newly diagnosed low grade prostate cancer, whose biopsy indicates a histopathologic Gleason grade of ≤ 3+4 severity and/or are candidates for active surveillance. The study is 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.

On March 24, 2017 Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX), an oncology company developing innovative medicines and other products for targeting and treating cancer, reported the publication of previously-reported results from the Phase 2 study of 1404 in the online edition of the Journal of Nuclear Medicine (Press release, Progenics Pharmaceuticals, MAR 24, 2017, View Source [SID1234518266]). 1404 is a PSMA-targeted small molecule SPECT/CT imaging agent that is designed to visualize prostate cancer.

The data published today reviews previously reported data demonstrating the sensitivity of 1404 to detect prostate cancer using both visual and semi-quantitative tumor to background (TBR) scores. The uptake within the prostate gland evaluated by both visual and TBR scores correlated significantly with Gleason Score.

“The results from this study highlight the potential for 1404 to better assess the stage and extent of a patient’s prostate cancer versus biopsy,” stated Professor Karolien Goffin, M.D., Ph.D., University Hospitals Leuven, author of the publication. “Importantly, 1404 may be used as a surrogate marker for Gleason Score, and could be used to evaluate lymph node involvement in patients with intermediate and high risk prostate cancer, which signals disease that has spread beyond the prostate. The data provide a strong rationale for continued development of 1404.”

Progenics is currently evaluating 1404 in a Phase 3 study. The study is enrolling patients with newly diagnosed low grade prostate cancer, whose biopsy indicates a histopathologic Gleason grade of ≤ 3+4 severity and/or are candidates for active surveillance. The study is 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.