Progenics Pharmaceuticals Announces Independent Committee’s Positive Recommendation for Continuation of Phase 3 Clinical Trial of SPECT/CT Imaging Agent 1404

NEW YORK, Dec. 22, 2016 -- Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX), an oncology company developing innovative medicines and other technologies for targeting and treating cancer, today announced that its independent Data Monitoring Committee (DMC) has completed review of an interim analysis of the Company’s ongoing Phase 3 clinical trial of its PSMA-targeted SPECT/CT imaging agent candidate, 99mTc-MIP-1404 (1404), and recommended that the trial continue.

“The growing acceptance of active surveillance among men with lower-grade prostate cancer presents a significant opportunity for 1404 to enable clinicians and patients to accurately and non-invasively visualize and manage their disease,” said Mark Baker, Chief Executive Officer of Progenics. “We are pleased that the DMC has determined that the trial should continue. The decision to undergo more invasive treatments, such as radical prostatectomy, is a difficult one for both patients and their families given the severity of potential side effects, and we look forward to the completion of this study as we work to introduce new and effective surveillance options.”   

This Phase 3 study enrolls 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 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.

Approximately 190 of a planned 450 patients have been enrolled in the trial to date.

A modification to the trial protocol has been proposed by the Company and agreed to by the U.S. Food and Drug Administration (FDA). The change permits patients with low to very low grade prostate cancer to participate in the trial without having to undergo a radical prostatectomy. In these patients, histopathology of tissues obtained from biopsies of those patients (rather than from radical prostatectomies) will be used as the truth standard in determining the specificity and sensitivity of 1404 imaging.  The modification of the protocol was proposed in response to a lower percentage of patients enrolled in the trial having clinically insignificant disease, which is likely due to the emerging trend for more men with low-grade disease to use active surveillance for the management of their prostate cancer rather than undergo radical prostatectomy. The Company plans to monitor enrollment of patients based on the prevalence of clinical significant disease before determining whether any adjustment is needed to the sample size of the study.

Mr. Baker continued, “Our modification to the protocol reflects emerging trends among men with low grade disease to increasingly favor the use of active surveillance versus more aggressive measures, consistent with treatment guidelines.  We believe that this shift underscores the potential for agents such as 1404 to address the growing active surveillance market. In addition, we expect that the protocol modification will allow for a better balance in the enrollment of subjects with clinically significant disease versus those with indolent disease, with the goal of evaluating the specificity of 1404 imaging to identify patients without clinically significant prostate cancer and the sensitivity of 1404 imaging to identify patients with clinically significant disease.”

About Progenics
Progenics Pharmaceuticals, Inc. is developing innovative medicines and other technologies for targeting and treating cancer, with a pipeline that includes several product candidates in later-stage clinical development. These products in development include therapeutic agents designed to precisely target cancer (AZEDRA^® and 1095), and PSMA-targeted imaging agents for prostate cancer (1404 and PyL^TM) intended to enable clinicians and patients to accurately visualize and manage their disease. In addition, in late 2015 Progenics acquired EXINI Diagnostics AB, a leader in the development of advanced artificial intelligence-based imaging analysis tools and solutions for medical decision support. The acquisition of EXINI complements Progenics' strategy to support its imaging and therapeutic agents with sophisticated analytical tools and other technologies to help physicians and patients visualize, understand, target and treat cancer. Progenics' 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 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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