EpiCept's Licensed Compound EP1013 Identified as a New Drug Candidate for Treatment of Late-Stage Viral Hepatitis
TARRYTOWN, N.Y.--(BUSINESS WIRE)--
Regulatory News:
EpiCept Corporation (Nasdaq OMX Stockholm Exchange and OTCQX: EPCT)
announced today that new preclinical research for its apoptosis
inhibitor drug candidate EP1013 (now renamed F573) has concluded that
F573 is a new therapeutic drug candidate for the treatment of late-stage
viral infection-induced hepatitis. The data were published in the
Chinese Pharmacological Bulletin (2102 Volume 28 (1):136-139). F573 was
discovered by EpiCept and licensed to GNI Group Ltd. in 2008 for
clinical development in Asia, Australia and New Zealand.
F573 delivered intravenously demonstrated a therapeutic effect in a
study involving 60 mice with acute liver injury, including a reduction
in TNF-a and cell apoptosis. GNI Group Ltd. also noted that F573
reduced mice mortality caused by acute liver injury and that these
animal studies provide important proof and direction for future human
studies.
EpiCept President and CEO Jack Talley commented, "This is the first
published evidence of F573's activity in viral hepatitis, an
inflammation of the liver caused mainly by three specific viruses
(hepatitis A, B and C). According to the C. Everett Koop Institute, 3-5
million Americans are infected with hepatitis C alone, with at least 170
million people infected globally. GNI's continued progress against this
disease may enable us to advance the development of the compound in
other territories, particularly North America and Europe."
As part of its license agreement with GNI Group Ltd., EpiCept is
eligible to receive milestone payments of more than $12 million based on
the clinical advancement of F573 in Asia, Australia and New Zealand, as
well as royalties on commercial sales. EpiCept retains the commercial
rights to F573/EP1013 in all other markets. The next potential milestone
payment would occur in conjunction with initiation of a Phase I trial in
any of the territories outlined in the agreement. In July 2011, Shanghai
Genomics, a wholly owned subsidiary of GNI Group Ltd., filed an
Investigational New Drug (IND) application for F573 in China.
About EP1013/F573
F573 is a di-peptide small-molecule compound with a potent inhibitory
effect on caspases, a class of enzymes involved in cell death and
inflammation. Drug efficacy has been shown in animal models relating to
liver failure, brain ischemia and myocardial infarction. GNI Group Ltd.
has secured a series of patent rights for F573 in China, Japan other key
territories from EpiCept Corporation to develop this drug for liver
diseases.
About EpiCept Corporation
EpiCept is focused on the development and commercialization of
pharmaceutical products for the treatment of pain and cancer. The
Company's pain portfolio includes AmiKet™, a prescription topical
analgesic cream in late-stage clinical development designed to provide
effective long-term relief of pain associated with peripheral
neuropathies. The Company's lead oncology product is Ceplene®,
which has been granted full marketing authorization by the European
Commission for the remission maintenance and prevention of relapse in
adult patients with Acute Myeloid Leukemia (AML) in first remission. The
Company has other oncology drug candidates currently in clinical
development that were discovered using in-house technology and have been
shown to act as vascular disruption agents in a variety of solid tumors.
In January 2012, EpiCept engaged SunTrust Robinson Humphrey to assist
the Company in exploring strategic alternatives to maximize the
commercial opportunity of AmiKet™ for the treatment of CIPN following
taxane-based therapy. The engagement is focused on the identification
and implementation of a strategy designed to optimize AmiKet's value for
the Company's stockholders, which includes the evaluation of potential
transactions involving the sale of the Company.
Forward-Looking Statements
This news release and any oral statements made with respect to the
information contained in this news release contain forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Such forward-looking statements include statements
which express plans, anticipation, intent, contingency, goals, targets,
future development and are otherwise not statements of historical fact.
These statements are based on our current expectations and are subject
to risks and uncertainties that could cause actual results or
developments to be materially different from historical results or from
any future results expressed or implied by such forward-looking
statements. Factors that may cause actual results or developments to
differ materially include: the risk that the development of our EP1013
product candidate will not be successful, the risk that we will not be
able to find a partner to help conduct the Phase III trials for AmiKet™
on attractive terms, a timely basis or at all, the risk that Ceplene®
will not receive regulatory approval or marketing authorization in the
United States or Canada, the risk that Ceplene® will not
achieve significant commercial success, the risk that any required
post-approval clinical study for Ceplene® will not be
successful, the risk that we will not be able to maintain our final
regulatory approval or marketing authorization for Ceplene®,
the risk that Azixa™ will not receive regulatory approval or achieve
significant commercial success, the risk that we will not receive any
significant payments under our agreement with Myrexis, , the risk that
clinical trials for AmiKet™ or crolibulinTM will not be
successful, the risk that AmiKet™ or crolibulinTM will not
receive regulatory approval or achieve significant commercial success,
the risk that our other product candidates that appeared promising in
early research and clinical trials do not demonstrate safety and/or
efficacy in larger-scale or later-stage clinical trials, the risk that
we will not obtain approval to market any of our product candidates, the
risks associated with the adequacy of our existing cash resources and
our ability to continue as a going concern, the risks associated with
our ability to continue to meet our obligations under our existing debt
agreements, the risks associated with dependence upon key personnel, the
risks associated with reliance on collaborative partners and others for
further clinical trials, development, manufacturing and
commercialization of our product candidates; the cost, delays and
uncertainties associated with our scientific research, product
development, clinical trials and regulatory approval process; our
history of operating losses since our inception; the highly competitive
nature of our business; risks associated with litigation; and risks
associated with our ability to protect our intellectual property. These
factors and other material risks are more fully discussed in our
periodic reports, including our reports on Forms 8-K, 10-Q and 10-K and
other filings with the U.S. Securities and Exchange Commission. You are
urged to carefully review and consider the disclosures found in our
filings which are available at www.sec.gov
or at www.epicept.com.
You are cautioned not to place undue reliance on any forward-looking
statements, any of which could turn out to be wrong due to inaccurate
assumptions, unknown risks or uncertainties or other risk factors.
*Azixa is a registered trademark of Myrexis, Inc.
EPCT-GEN
EpiCept Corporation:
Robert W. Cook, 914-606-3500
rcook@epicept.com
or
Media:
Feinstein
Kean Healthcare
Greg Kelley, 617-577-8110
gregory.kelley@fkhealth.com
or
Investors:
LHA
Kim
Sutton Golodetz, 212-838-3777
kgolodetz@lhai.com
or
Bruce
Voss, 310-691-7100
bvoss@lhai.com
@LHA_IR_PR
Source: EpiCept Corporation
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