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Progenics Pharmaceuticals Commences Pivotal Phase 3 Study of PSMA Targeted Imaging Agent 1404 for Prostate Cancer

TARRYTOWN, N.Y., Jan. 07, 2016 (GLOBE NEWSWIRE) -- Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX) announced today that it has begun enrollment in its pivotal Phase 3 clinical trial evaluating 1404, a small molecule being developed as an imaging agent for prostate cancer. 1404 targets prostate specific membrane antigen (PSMA), which is abundantly expressed on prostate cancer cells.

This Phase 3 clinical trial is expected to enroll approximately 450 patients with newly diagnosed low-grade prostate cancer who are candidates for active surveillance, but nonetheless are planning to undergo radical prostatectomy. This multi-center, open-label trial will evaluate the sensitivity and specificity of 1404 in correctly identifying whether or not patients have clinically significant prostate cancer (generally, Gleason score >3+4). In this trial, patients will be imaged prior to their scheduled radical prostatectomy. The truth standard in establishing the sensitivity and specificity of 1404 will be the histopathologist’s grading of the prostate tissue removed in the prostatectomy, which will be compared to the 1404 image assessments. An interim analysis of the study will be performed after approximately one-third of the subjects have been enrolled to assess futility and evaluate the need for a sample size re-estimation.

“An imaging agent like 1404, which may discriminate clinically significant prostate cancer from indolent disease, would provide a useful tool for disease management and treatment, as well as further supporting the use of active surveillance,” said William J. Ellis M.D., Professor, Department of Urology, University of Washington School of Medicine and Lead Investigator for the Phase 3 Study. “The goal of active surveillance is to monitor low-grade disease and avoid the risks and complications associated with unnecessary surgical or therapeutic treatments; however, biopsies and other measures currently used to monitor disease progression have their own limitations and risks, curtailing the broader use of active surveillance.”

“Commencing this Phase 3 study represents a significant step forward in the clinical development of 1404 and our efforts to bring forward a portfolio of PSMA-targeted imaging agents to help detect and monitor prostate cancer,” stated Mark Baker, CEO of Progenics. “We look forward to the timely completion of this trial as we advance 1404 for the detection of clinically significant disease in prostate cancer patients who are candidates for active surveillance.”

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 220,800 new cases of prostate cancer will be diagnosed and about 27,540 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. is developing innovative medicines for oncology, with a pipeline that includes several product candidates in later-stage clinical development. Among the assets in its pipeline of targeted radiotherapy and molecular imaging compounds is AZEDRA, an ultra-orphan radiotherapy candidate currently in a phase 2 study under an SPA. The Company’s PSMA-targeted product candidates for prostate cancer include two small molecule imaging agents 1404 and PyL, and two therapeutic agents PSMA ADC, an antibody drug conjugate, and 1095, a small molecule radiotherapeutic. Progenics’s first commercial product, RELISTOR® (methylnaltrexone bromide) for opioid-induced constipation, is partnered with and marketed by 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 the Phase 3 clinical program for 1404; our ability to successfully complete our tender offer for and 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 sales of products by our partners 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 (914) 789-2801 mdowns@progenics.com

Source:Progenics Pharmaceuticals