EpiCept Reports Positive Results from EpiCept™ NP-1 Trial in Patients with Chemotherapy-Induced Peripheral Neuropathy


EpiCept Reports Positive Results from EpiCept™ NP-1 Trial in Patients
with Chemotherapy-Induced Peripheral Neuropathy

All Primary Endpoints Met with Statistical Significance

TARRYTOWN, N.Y.--(BUSINESS WIRE (http://www.businesswire.com/))--
Regulatory News:

EpiCept Corporation (Nasdaq and Nasdaq OMX Stockholm Exchange: EPCT)
today announced positive results from a Phase IIb trial evaluating the
efficacy and safety of EpiCept™ NP-1 (NP-1) in chemotherapy-induced
peripheral neuropathy (CPN). EpiCept NP-1 is a topical analgesic cream
containing two FDA-approved drugs, amitriptyline and ketamine, in
development for the relief of pain from various peripheral neuropathies.

The multi-center, double-blind, randomized, placebo-controlled study was
conducted by the National Cancer Institute (NCI)-funded Community
Clinical Oncology Program. More than 460 cancer survivors suffering from
painful CPN were enrolled in the six-week study. The results of the
trial in the intent to treat (ITT) population demonstrated that the
change in average daily neuropathy intensity scores in the NP-1 group
achieved a statistically significant reduction in CPN intensity versus
placebo (p<0.001), which was the trial's primary endpoint. Additionally,
a pre-specified subgroup of the ITT population, those patients who
previously received taxane chemotherapy, also showed a statistically
significant reduction in average daily neuropathy intensity scores
(p=0.034). This subgroup constituted more than 50% of the ITT
population. Secondary efficacy endpoints confirmed the superiority of
NP-1 vs. placebo. Furthermore, the safety profile of NP-1 was comparable
to placebo.

“CPN is an area of great unmet medical need,” said Jack Talley, EpiCept
President and CEO. “Millions of cancer survivors suffer from the effects
of their chemotherapy and no treatment is yet approved for this painful
indication. We are very excited about the positive results achieved by
NP-1 in this trial and are highly optimistic about its potential to be a
new and effective treatment option for sufferers of CPN. We look forward
to discussing these results with prospective partners for the Phase III
development and commercialization of NP-1.”

The National Cancer Institute estimates that 30-40% of cancer patients
treated with chemotherapy experience symptoms of CPN, which impairs
their quality of life and ability to function. The debilitating, chronic
pain of CPN is one of the most common reasons why cancer patients stop
their treatment early. More than one million breast cancer survivors in
the United States alone suffer from this disease, for which there is no
effective therapy.

The results of this trial build upon EpiCept's clinical development of
NP-1 in both diabetic and post-herpetic neuropathies. The Company has
enrolled more than 1,700 patients into clinical trials of NP-1,
including a 360-patient trial that studied NP-1's efficacy compared with
gabapentin and placebo in post-herpetic neuropathy, for which positive
results were previously reported.

About EpiCept™ NP-1 and Peripheral Neuropathy

EpiCept™ NP-1 cream is a patented formulation containing two
FDA-approved drugs, amitriptyline (a widely-used antidepressant) and
ketamine (an NMDA antagonist that is used as an anesthetic), designed to
provide effective, long-term relief from the pain of peripheral
neuropathies. Peripheral neuropathies are medical conditions caused by
damage to the nerves in the peripheral nervous system. The peripheral
nervous system includes nerves that run from the brain and spinal cord
to the rest of the body. Peripheral neuropathies are associated with
conditions that injure peripheral nerves, including herpes zoster, or
shingles, diabetes, chemotherapy, HIV and other diseases. Peripheral
neuropathies can also be caused by trauma or may result from surgical
procedures.

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 product is Ceplene®, approved in the European Union for
the remission maintenance and prevention of relapse in adult patients
with Acute Myeloid Leukemia (AML) in first remission. In the United
States., a pivotal trial is scheduled to commence in 2011. The Company
has two 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 EpiCept™ NP-1, 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
that 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 clinical trials for EpiCept™
NP-1 will not be successful, the risk that EpiCept™ NP-1 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 EpiCept™ NP-1 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, 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 future financing will not successfully close or that the proceeds
thereof will be materially less than anticipated, 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 crolibulinTM will not be
successful, the risk that 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 risk that
our securities may be delisted from Nasdaq; 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 (http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%
2F%2Fus.lrd.yahoo.com%2F_ylt%3DAgfqFPfVOEK5M4_Rv8aJvhTjba9_%3B_ylu%3DX3o
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x=1&md5=a71e26ab1b91673da8164d939aeeaa27) or at
www.epicept.com (http://cts.businesswire.com/ct/CT?id=smartlink&url=http
%3A%2F%2Fus.lrd.yahoo.com%2F_ylt%3DAhBuoawHw6iS3RhJOH9dNNfjba9_%3B_ylu%3
DX3oDMTE2OGhhcWs4BHBvcwMzBHNlYwNuZXdzYXJ0Ym9keQRzbGsDd3d3ZXBpY2VwdGNv%2F
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smartlink%2526url%3Dhttp%25253A%25252F%25252Fwww.epicept.com%2526esheet%
3D6170045%2526lan%3Den_US%2526anchor%3Dwww.epicept.com%2526index%3D3%252
6md5%3D8b3a48c3367e26fcfbd15295b6d82118&esheet=6600112&lan=en-US&anchor=
www.epicept.com&index=2&md5=31ce50d4e914afcf5dda89acc5a37cc9). 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.

EPCT-GEN

*Azixa is a registered trademark of Myrexis, Inc.

EpiCept Corporation:
Robert W. Cook, 914-606-3500
mail@epicept.com (mail@epicept.com)
or
Media:
Feinstein Kean Healthcare
Greg Kelley, 617-577-8110
gregory.kelley@fkhealth.com (gregory.kelley@fkhealth.com)
or
Investors:
Lippert/Heilshorn & Associates
Kim Sutton Golodetz, 212-838-3777
kgolodetz@lhai.com (kgolodetz@lhai.com)
or
Bruce Voss, 310-691-7100
bvoss@lhai.com (bvoss@lhai.com)

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