Progenics Pharmaceuticals Completes Enrollment in Phase 3 Study of PSMA-Targeted Imaging Agent 1404
January 02 2018 - 8:30AM
Progenics Pharmaceuticals, Inc. (NASDAQ:PGNX), an oncology company
developing innovative medicines and imaging analytical tools for
targeting and treating cancer, today announced that it has
completed enrollment in its Phase 3 study of 1404, a PSMA-targeted
small molecule SPECT/CT imaging agent that is designed to visualize
prostate cancer.
“The results of this large-scale Phase 3 study
will provide important insights on the potential of our novel
imaging agent to accurately and non-invasively detect and monitor
patients with low-grade prostate cancer,” said Mark Baker, Chief
Executive Officer of Progenics. “We believe that 1404 has the
possibility to transform the practice of active surveillance, and
we look forward to providing top-line results in the third
quarter.”
The Phase 3 study enrolled approximately 450
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 was 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 develops innovative medicines and
other technologies to target and treat cancer. Progenics' pipeline
includes: 1) therapeutic agents designed to precisely target cancer
(AZEDRA® and 1095), 2) PSMA-targeted imaging agents for prostate
cancer (1404 and PyL™), 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 the Phase 3
clinical program for 1404; our ability to successfully develop and
commercialize the products of EXINI Diagnostics AB; the
unpredictability of the duration and results of regulatory review
of New Drug Applications (NDA) and Investigational NDAs, including
our NDA for AZEDRA and related inspections of Progenics’ and its
contract manufacturing organizations’ facilities and other sites
and other requirements that will need to be met before any approval
is obtained; 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, regulatory 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, including those risk factors included in
its Quarterly Report on Form 10-Q for the quarterly period
ended March 31, 2017, as updated in its Quarterly Report on
Form 10-Q for the quarterly period ended June 30, 2017.
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.
Additional information concerning Progenics and
its business may be available in press releases or other public
announcements and public filings made after this release. For more
information, please visit www.progenics.com. Information on or
accessed through our website or social media sites is not included
in the company's SEC filings. (PGNX-F)
Contact:Melissa DownsInvestor Relations (646)
975-2533 mdowns@progenics.com
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