BRIDGEWATER, N.J.--(BUSINESS WIRE)--
Enzon Pharmaceuticals, Inc. (Nasdaq: ENZN) today announced the
Investigational New Drug (IND) approval by the US Food and Drug
Administration (FDA) and plan to commence enrollment into a Phase 1a/1b
study shortly. The study will evaluate the safety and tolerability of
EZN-4176, the company's novel androgen receptor (AR) mRNA antagonist,
for the treatment of patients with castration-resistant prostate cancer
(CRPC). Unlike other novel agents for CRPC that inhibits androgen
production or receptor activation, EZN-4176 is unique in its ability to
eliminate androgen receptor.
The open-label, Phase 1a/1b, non-randomized study will enroll adult
patients with CRPC, who will receive EZN-4176 as a weekly, one-hour
intravenous infusion in four-week treatment cycles. The study will have
two phases: Phase 1a will determine the maximum tolerated dose, after
which pharmacokinetic and pharmacodynamic studies will be conducted at
one or more dose levels in Phase 1b to determine the recommended Phase 2
dose.
Enzon's initiation of this study follows the presentation of preclinical
data at the 2010 EORTC-NCI-AACR meeting demonstrating potent anti-tumor
activity for EZN-4176, both alone and in combination with MDV-3100, a
novel AR antagonist that is currently in Phase 3 testing.
Prostate cancer is a common cause of cancer-related deaths among men in
the United States, a fact that underscores the need for new treatment
options, particularly for late-stage disease. In the preclinical
setting, EZN-4176 exhibited robust tumor-growth inhibition that
correlated with down-modulation of the AR, and consequently inhibition
of transcription activity.
Ivan Horak, MD, Enzon's president of research and development and chief
scientific officer, commented, "The initiation of this study marks an
important step in the advancement of Enzon's third-generation mRNA
antagonists, which are based on proprietary Locked Nucleic Acid
technology. We believe that the enhanced stability, potency and affinity
of these compounds will translate to meaningful improvements in the
treatment of CRPC and other cancers with high unmet medical need."
About EZN-4176 (androgen receptor mRNA antagonist)
EZN-4176, an androgen receptor (AR) mRNA antagonist, is a Locked Nucleic
Acid (LNA) oligonucleotide that specifically down-modulates AR mRNA. In
vitro, EZN-4176 has been shown to down-modulate AR mRNA and protein, and
inhibit AR transcriptional activity and cell growth. AR is widely
recognized as an important therapeutic target for the treatment of
prostate cancer, as androgens are essential to prostate tumor growth and
viability. EZN-4176 is based on Enzon's proprietary LNA technology
platform targets, which were licensed from Santaris Pharma A/S. The LNA
technology allows the antisense molecule to have high-potency resistance
to nuclease destruction, and administration of the molecule
intraveneously when prepared in saline (without any delivery vehicle).
About Enzon
Enzon Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to
the development of innovative medicines for patients with cancer.
Enzon's drug development programs utilize several approaches, including
its cutting-edge proprietary Customized Linker Technology utilizing
PEGylation and mRNA antagonists using the Locked Nucleic Acid (LNA)
technology. Enzon receives a royalty revenue stream from licensing
arrangements for other products developed using the proprietary
Customized Linker Technology. Further information about Enzon and this
press release can be found on the Company's web site at www.enzon.com.
Forward Looking Statements
There are forward-looking statements contained herein, which can be
identified by the use of forward-looking terminology such as the words
"believes," "expects," "may," "will," "should," "potential,"
"anticipates," "plans," or "intends" and similar expressions. Such
forward-looking statements involve known and unknown risks,
uncertainties and other factors that may cause actual results, events or
developments to be materially different from the future results, events
or developments indicated in such forward-looking statements. Such
factors include, but are not limited to the timing, success and cost of
clinical studies for Enzon's product candidates; the ability to obtain
regulatory approval of product candidates, Enzon's ability to obtain the
funding necessary to develop its product candidates, market acceptance
of, and demand for, Enzon's product candidates and the impact of
competitive products, pricing and technology. A more detailed discussion
of these and other factors that could affect results is contained in our
filings with the U.S. Securities and Exchange Commission, including our
annual report on Form 10-K for the year ended December 31, 2009. These
factors should be considered carefully and readers are cautioned not to
place undue reliance on such forward-looking statements. No assurance
can be given that the future results covered by the forward-looking
statements will be achieved. All information in this press release is as
of the date of this press release and Enzon does not intend to update
this information.
Argot Partners
Andrea Rabney, 212-600-1902
andrea@argotpartners.com
Source: Enzon Pharmaceuticals, Inc.
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