EpiCept Corporation Receives FDA Permission to Initiate AmiKet™ Phase III Clinical Development
TARRYTOWN, N.Y.--(BUSINESS WIRE)--
Regulatory News:
EpiCept Corporation (Nasdaq OMX Stockholm Exchange and OTCQX: EPCT)
today announced that at a meeting earlier this week with the U.S. Food
and Drug Administration (FDA), the Company was granted permission to
initiate immediately the Phase III clinical development of AmiKet™.
AmiKet™ (4% amitriptyline, 2% ketamine) is a prescription topical cream
intended for the treatment of chemotherapy-induced peripheral neuropathy
(CIPN) following taxane-based therapy.
Jack Talley, EpiCept President and CEO, commented, "The guidance we
received from the FDA during our End of Phase II meeting will permit a
quick initiation of AmiKet's remaining clinical development required for
a new drug application (NDA). Every year, millions of cancer survivors
suffer from the effects of their chemotherapy, and no treatment is yet
approved to treat CIPN. AmiKet™ represents a potentially significant
benefit to patients suffering from this painful indication, and may
address an unmet medical need that is well recognized."
The FDA indicated that a CIPN treatment protocol submitted by the
Company will be reviewed expeditiously for a Special Protocol Assessment
(SPA).
The Company has submitted its draft meeting minutes for FDA concurrence
and upon receipt of the FDA official meeting minutes will provide more
details regarding the clinical and non-clinical package required prior
to an NDA filing.
About AmiKet™
AmiKet™ is a prescription, topical analgesic cream containing 4%
amitriptyline and 2% ketamine designed to provide relief from
neuropathic pain, which affects more than 15 million people in the U.S.
alone. In the first half of 2011, EpiCept announced positive results
from a National Cancer Institute-sponsored study evaluating the efficacy
and safety of AmiKet™ in chemotherapy-induced peripheral neuropathy
(CIPN), a painful condition that frequently occurs following systemic
chemotherapy and that may interrupt, delay or even prevent completion of
potentially curative chemotherapy regimens. A safe and effective
therapeutic option for neuropathic pain associated with CIPN would
address a significant unmet medical need.
About EpiCept Corporation
EpiCept is focused on the development and commercialization of
pharmaceutical products for the treatment of cancer and pain. 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. 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.
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 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 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
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 the
development of our other apoptosis product candidates will not be
successful, 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 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 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 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; the risk that
our securities may be delisted from Nasdaq; 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
Source: EpiCept Corporation
News Provided by Acquire Media
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