NEW YORK, March 24, 2017 (GLOBE NEWSWIRE) -- Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX ), an oncology company developing innovative medicines and other products for targeting and treating cancer, today announced the publication of previously-reported results from the Phase 2 study of 1404 in the online edition of the Journal of Nuclear Medicine. 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.
About Progenics
Progenics Pharmaceuticals, Inc. develops innovative medicines and other technologies to target and treat cancer. The Company's pipeline includes: 1) therapeutic agents designed to precisely target cancer (AZEDRA ® and 1095), 2) PSMA-targeted imaging agents for prostate cancer (1404 and PyL TM ), and 3) imaging analysis tools. Progenics' first commercial product, RELISTOR ® (methylnaltrexone bromide) for opioid-induced constipation, is partnered with Valeant Pharmaceuticals International, Inc.
This press release may contain projections and other "forward-looking statements" regarding future events. Statements contained in this communication that refer to Progenics' estimated or anticipated future results or other non-historical facts are forward-looking statements that reflect Progenics' current perspective of existing trends and information as of the date of this communication. Forward looking statements generally will be accompanied by words such as "anticipate," "believe," "plan," "could," "should," "estimate," "expect," "forecast," "outlook," "guidance," "intend," "may," "might," "will," "possible," "potential," "predict," "project," or other similar words, phrases or expressions. Such statements are predictions only, and are subject to risks and uncertainties that could cause actual events or results to differ materially. These risks and uncertainties include, among others, the cost, timing and unpredictability of results of clinical trials and other development activities and collaborations, such as our collaboration with Valeant on the RELISTOR oral formulation and the Phase 3 clinical program for 1404; our ability to successfully integrate EXINI Diagnostics AB and to develop and commercialize its products; the unpredictability of the duration and results of regulatory review of New Drug Applications and Investigational NDAs; market acceptance for approved products; the effectiveness of the efforts of our partners to market and sell products on which we collaborate and the royalty revenue generated thereby; generic and other competition; the possible impairment of, inability to obtain and costs of obtaining intellectual property rights; possible product safety or efficacy concerns, general business, financial and accounting matters, litigation and other risks. More information concerning Progenics and such risks and uncertainties is available on its website, and in its press releases and reports it files with the U.S. Securities and Exchange Commission. Progenics is providing the information in this press release as of its date and, except as expressly required by law, Progenics disclaims any intent or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or circumstances or otherwise.
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Contact: Melissa Downs Investor Relations (646) 975-2533 mdowns@progenics.com
