Progenics Pharmaceuticals Announces First Patient Dosed in Phase 2/3 Clinical Trial of PSMA-Targeted PET/CT Imaging Agent PyL...
December 07 2016 - 8:30AM
Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX), an oncology company
developing innovative medicines and other products for targeting
and treating cancer, today announced that the first patient has
been dosed in the Company’s Phase 2/3 clinical trial evaluating the
diagnostic accuracy of its PSMA-targeted PET/CT imaging agent,
18F-DCFPyL (PyLTM). PyL was discovered by a team led by
Martin G. Pomper, M.D., Ph.D., William R. Brody Professor of
Radiology at the Center for Translational Molecular Imaging at the
Johns Hopkins University School of Medicine.
“There exists a significant need for approved
molecular imaging modalities with both high sensitivity and
specificity to detect high risk recurrent or metastatic prostate
cancer early,” said Lawrence Saperstein, M.D., Assistant Professor,
Department of Radiology and Biomedical Imaging, Chief, Nuclear
Medicine Program Director, Nuclear Radiology Fellowship, Yale
University School of Medicine, where the first patient was dosed.
“We believe PyL, when used with a PET/CT scan, can provide treating
physicians with more accurate disease detection, potentially
leading to earlier diagnoses, more informed treatment decisions as
well as the ability to monitor responses, and ultimately improved
patient outcomes.”
The Phase 2/3 study will enroll approximately 300
patients with high risk prostate cancer with recurrence or
metastatic disease in the United States and Canada. Primary
endpoints of the study include the assessment of sensitivity and
specificity of PyL PET/CT imaging to detect prostate cancer in the
prostate gland and regional lymph nodes, as well as sensitivity in
sites of metastasis or recurrence. Secondary endpoints
include safety and tolerability, detection rate, and
pharmacokinetic parameters.
“This trial initiation represents a significant
milestone for our PyL program, and is designed to help support
registration of this novel imaging agent,” stated Mark Baker, Chief
Executive Officer of Progenics. “The early clinical data for PyL
have been quite impressive, underscoring its potential to transform
disease management for prostate cancer, and we look forward to
further demonstrating its diagnostic performance as we advance the
trial.”
About PyL for PET Imaging of Prostate
Cancer
PyL (also known as 18F-DCFPyL) is a clinical-stage,
fluorinated PSMA-targeted PET imaging agent for prostate cancer
that was discovered and developed at the Center for Translational
Molecular Imaging at the Johns Hopkins University School of
Medicine. A proof-of-concept study published in the April 2015
issue of the Journal of Molecular Imaging and Biology demonstrated
that PET imaging with PyL showed high levels of PyL uptake in sites
of putative metastatic disease and primary tumors, while rapidly
clearing from other organs, suggesting the potential for high
sensitivity and specificity in detecting prostate cancer while
appearing to be safe and well tolerated.
About Progenics
Progenics Pharmaceuticals, Inc. is developing
innovative medicines and other products 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 PyLTM) 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.
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. Please follow us on
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(PGNX-F)
Contact:
Melissa Downs
Investor Relations
(646) 975-2533
mdowns@progenics.com
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