EpiCept Announces Positive Results from Phase IIb Trial for EpiCeptTM NP-1

EpiCept Announces Positive Results from Phase IIb Trial for EpiCeptTM NP-1 

All Primary Endpoints Met, Efficacy Superior to Placebo, Equivalent to
Gabapentin 

TARRYTOWN, N.Y.--(BUSINESS WIRE)--EpiCept Corporation (Nasdaq and OMX Nordic
Exchange: EPCT) announced today positive results from its Phase IIb randomized,
double blind, placebo controlled non-inferiority trial of its prescription
topical analgesic EpiCeptTM NP-1 Cream in post-herpetic neuralgia (PHN). The
trial met its primary endpoints and demonstrated a favorable safety profile
compared with gabapentin. 

The 360 patient, active comparator trial compared the efficacy and safety of
NP-1 against both gabapentin and placebo. The first primary endpoint was the
change in pain intensity over the four week duration of the trial. The data
demonstrated that NP-1 achieved statistically significant superior efficacy
compared with placebo (p=0.024). An additional primary endpoint, to demonstrate
that NP-1 was not inferior to gabapentin in reducing pain, was also met. A key
secondary endpoint measured in the trial from a responder analysis indicated
that 63% of patients in the NP-1 treatment arm achieved a reduction in pain
scores of at least 30%, significantly higher than that of patients in the
placebo arm (p=0.033). Top-line data results further indicate that NP-1 achieved
a superior safety profile when compared with gabapentin, especially with regard
to dizziness and somnolence, as evaluated by the reporting of adverse events. 

“These positive data further demonstrate the significant potential of NP-1 to
provide long-term relief to patients affected by the pain of peripheral
neuropathies, a condition which afflicts more than 15 million people in the U.S.
alone. We are particularly pleased in this study to demonstrate that NP-1 has at
least equivalent efficacy to the unit market leader, gabapentin,” stated Jack
Talley, President and Chief Executive Officer of EpiCept. “With about $3 billion
spent annually in the U.S on neuropathic pain therapeutics, the market potential
for an effective treatment for this indication is considerable. We expect these
highly positive results will facilitate our efforts to find an attractive
partner to help conduct the Phase III trials for NP-1.” 

The PHN trial is one of three trials recently completed or currently ongoing
that is studying the effects of NP-1 on various indications within peripheral
neuropathy and which are intended to broaden NP-1's potential labeling for the
treatment of peripheral neuropathies. In February 2008, EpiCept reported
encouraging results from a Phase II trial for NP-1 in Diabetic Peripheral
Neuropathy (DPN), which the Company believes support the advancement of NP-1 to
a pivotal trial. A trial in chemotherapy-induced peripheral neuropathy (CPN) is
also currently being conducted by the National Cancer Institute (NCI)-funded
Community Clinical Oncology Program. 

About EpiCept NP-1 

EpiCept NP-1 is a prescription topical analgesic cream 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. 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). 

About EpiCept Corporation 

EpiCept is focused on unmet needs in the treatment of cancer and pain. The
Company's broad portfolio of pharmaceutical product candidates includes
Ceplene®, a cytokine immunomodulator that recently received marketing
authorization in Europe for the remission maintenance of AML patients, and
several pain therapies in clinical development. Two oncology drug candidates
currently in clinical development that were discovered using in-house technology
have also been shown to act as vascular disruption agents in a variety of solid
tumors. 

Forward-Looking Statements 

This news release and any oral statements made with respect to the information
contained in this news release, contains 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 EpiCept's 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 we may not realize our anticipated cost savings, the
risks associated with the adequacy of our existing cash resources, our need to
raise additional financing to continue to meet our capital needs 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 or that we
may default on our loans or that our lenders may declare the Company in default
or that our secured lender would seek to sell our assets, the risk that the
Company's securities may be delisted by The Nasdaq Capital Market or the OMX
Nordic Exchange and that any appeal of the delisting determination may not be
successful, the risk that Ceplene® will not receive regulatory approval or
marketing authorization in the U.S. or Canada, the risk that Ceplene® will not
be launched in Europe in the first half of 2009 or achieve significant
commercial success, the risk that we are unable to find a suitable marketing
partner for Ceplene® on attractive terms, a timely basis or at all, the risk
that any required post-approval clinical study will not be successful, the risk
that EpiCept will not be able to maintain its final regulatory approval or
marketing authorization, the risk that Myriad's development of Azixa™ will not
be successful, 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 Myriad, the risk that the
development of our other apoptosis product candidates will not be successful,
the risk that we will not be able to find a buyer for our ASAP technology, the
risk that clinical trials for NP-1 or EPC-2407 will not be successful, the risk
that NP-1 or EPC-2407 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 NP-1 on attractive terms or a
timely basis 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 other product candidates, the risks
associated with our 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 EpiCept's periodic reports, including its
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 EpiCept's 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. 

EPCT-GEN 

*Azixa is a registered trademark of Myriad Genetics, Inc. 


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:
Lippert/Heilshorn & Associates
Kim Sutton Golodetz, 212-838-3777
kgolodetz@lhai.com
or
Bruce Voss, 310-691-7100
bvoss@lhai.com