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Progenics Announces the Initiation of Fuji's Phase 2 Trial for 1404 in Japan

TARRYTOWN, N.Y., April 7, 2015 (GLOBE NEWSWIRE) -- Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX) today announced that its partner, FUJIFILM RI Pharma Co. Ltd. (Fuji), has dosed the first patient in its early Phase 2 trial of 1404 in Japan in newly-diagnosed prostate cancer patients with lymph node and/or bone metastases or at high risk for metastatic disease. 1404 is a targeted small molecule designed to visualize prostate cancer by targeting prostate specific membrane antigen (PSMA).

"1404 holds tremendous promise as the most advanced PSMA-targeted imaging agent in development today, and the initiation of this trial reflects Fuji's commitment to 1404 following the impressive data from our own Phase 2 study," stated Mark Baker, CEO of Progenics. "We have demonstrated that 1404 can provide diagnostic information for both primary and metastatic prostate cancer in a single scan, and we look forward to seeing the Japanese development program progress in parallel with our own plans in the United States."

The early Phase 2 trial in Japan is a multi-center, open-label study evaluating the uptake of 1404 within the prostate gland, pelvic lymph node and/or bone metastases as well as safety in men with high risk for metastatic prostate cancer, using both whole-body planar and SPECT/CT imaging modalities.

About 1404, an Imaging Compound Targeting Prostate Specific Membrane Antigen

1404 is a developmental stage radiopharmaceutical imaging agent designed to highlight the expression of distinct proteins by diseased cells. 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 six will be diagnosed with prostate cancer in his lifetime. The American Cancer Society estimates that approximately 240,000 new cases of prostate cancer will be diagnosed and about 30,000 men will die of the disease this year, and that approximately two 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. Progenics' first-in-class PSMA-targeted technology platform for prostate cancer includes an antibody drug conjugate therapeutic which completed a two-cohort phase 2 clinical trial and a small molecule imaging agent that has also completed a phase 2 trial. Among other 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. Progenics' first commercial product, Relistor® (methylnaltrexone bromide) for opioid-induced constipation, is partnered with and marketed by Salix Pharmaceuticals, Inc. For additional information, please visit www.progenics.com.

This press release may contain projections and other forward-looking statements regarding future events. 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 results of clinical trials and other development activities; 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; and possible 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 does not undertake any obligation to update or revise it, whether as a result of new information, future events or circumstances or otherwise.

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Editor's Note:

For more information, please visit www.progenics.com.

For more information about Relistor, please visit www.relistor.com.

CONTACT: Melissa Downs Investor Relations (914) 789-2801 mdowns@progenics.com

Source:Progenics Pharmaceuticals Inc.