Progenics Pharmaceuticals Announces That Data From a Phase I Study of Its 1404
Imaging Agent Has Been Presented at the Society for Urologic Oncology Meeting
– Progenics' Imaging Agent Correctly Identified the Presence of Primary
Prostate Cancer in 100% of Phase I Study Subjects
– Progenics Also Announces That Topline Data From a Recently Completed Phase
II Trial of 1404 Will be Presented at ASCO GU in January 2014
TARRYTOWN, N.Y., Dec. 6, 2013 (GLOBE NEWSWIRE) -- Progenics Pharmaceuticals,
Inc. (Nasdaq:PGNX) an oncology company focused on the development of
innovative approaches to targeting and treating prostate cancer, announced
that findings from a Phase I study of its Imaging Agent, 1404, were presented
today at the meeting of the Society for Urologic Oncology in Rockville,
The poster, entitled A Phase I Study of TC-99-M-MIP-1404 SPECT/CT to Identify
and Localize High Grade Cancer in the Prostate Gland, was presented by Kevin
Slawin, M.D., Director, Vanguard Urologic Institute, Memorial Hermann-TMC. "In
this study, the presence of primary prostate cancer was correctly identified
in eight of eight patients by SPECT/CT imaging with 1404," said Dr. Slawin.
"An imaging agent with this high degree of accuracy has the potential to allow
doctors and their patients to focus on the treatment of aggressive cancers
while more conservatively managing low grade cancers."
"The successful development of an initial and ongoing treatment plan for the
management of prostate cancer is often handicapped by the inability to
accurately assess the presence, location, grade and extent of the disease,"
said Hagop Youssoufian, M.Sc., M.D., Executive Vice President, Research &
Development at Progenics. "Accurate diagnosis and staging is imperative to
avoid overtreatment of indolent disease, with its potential life changing side
effects, including incontinence and impotence, and the underestimation of
aggressive disease.In this Phase I trial our imaging agent identified primary
prostate cancer with a high degree of accuracy and, in addition, may have the
ability to discriminate high grade prostate cancer from moderate and low grade
disease.We believe this is the kind of information men suffering from
prostate cancer and their doctors need in order to best manage their disease."
About 1404, an Imaging Compound targeting Prostate Specific Membrane Antigen
1404 is a developmental stage radiopharmaceutical imaging agent that is
designed to highlight the expression of a distinct protein by cancerous
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.Approximately 2 million men in the U.S.
currently count themselves among prostate cancer survivors.
Progenics Pharmaceuticals, Inc. is developing innovative medicines for
oncology, with a pipeline that includes several product candidates in
late-stage clinical development. Progenics' first-in-class PSMA targeted
technology platform includes an antibody drug conjugate therapeutic and a
small molecule targeted imaging agent, both completing phase 2 clinical
trials. Among other assets in its pipeline of targeted radiotherapy and
molecular imaging compounds is Azedra^™, an ultra-orphan radiotherapy
candidate also in a registrational phase 2 study under a SPA with the FDA.
Progenics' first commercial product, Relistor^® (methylnaltrexone bromide) for
opioid-induced constipation, is partnered with and marketed by Salix
Pharmaceuticals, Inc. Ono Pharmaceutical Co. has licensed subcutaneous
Relistor in Japan. 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; 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.
Additional information concerning Progenics and its business may be available
in press releases or other public announcements and public filings made after
Information on or accessed through our website is not included in the
company's SEC filings.
For more information, please visit www.progenics.com.
CONTACT: Kathleen Fredriksen
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