Progenics Pharmaceuticals Announces Independent Committee’s Positive Recommendation for Continuation of Phase 3 Clinical Tr...
December 22 2016 - 4:15PM
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 ProgenicsProgenics
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 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
LinkedIn®. Information on or accessed through our website or social
media sites is not included in the company's SEC filings.
(PGNX-F)
Contact:
Melissa Downs
Investor Relations
(646) 975-2533
mdowns@progenics.com
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