EpiCept Reports New Analysis Supports Ceplene's Favorable Impact on Overall Survival

EpiCept Reports New Analysis Supports Ceplene's Favorable Impact on
Overall Survival

TARRYTOWN, N.Y.--(BUSINESS WIRE (http://www.businesswire.com/))--
EpiCept Corporation (Nasdaq and Nasdaq OMX Stockholm Exchange: EPCT)
today announced the results of a new analysis supporting Ceplene's
(histamine dihydrochloride) favorable impact on overall survival and its
activity with interleukin-2 (IL-2). Ceplene® is approved in the European
Union for the maintenance of first remission in patients with Acute
Myeloid Leukemia (AML) in conjunction with low dose IL-2.

EpiCept announced in October 2010 that it reached agreement with the
U.S. Food and Drug Administration (FDA) for a two-arm, randomized,
open-label trial that will compare the efficacy of Ceplene® plus
low-dose IL-2 to standard practice in this indication. Based on FDA
guidance, the primary endpoint of the trial will be overall patient
survival.

In designing this new trial, EpiCept will be guided by the results of
the previous Phase III trial for Ceplene® and more particularly by the
results of a new subset analysis of 190 patients that were treated
aggressively with consolidation therapy before being randomized into the
trial. Within this subset of patients, a difference in overall patient
survival was seen in favor of Ceplene®/IL-2 versus standard of care
(p-value = 0.07, with a median overall benefit of 36 months). This
outcome suggests that statistically significant improved overall
survival could be achieved in an adequately powered clinical trial.

As previously announced on December 5, 2010, a poster for Ceplene® was
presented at the 52nd Annual Meeting of the American Society of
Hematology (ASH), which revealed the findings from a Bayesian
meta-analysis comparing Ceplene + IL-2 versus IL-2 alone in leukemia
free survival in AML patients in remission.

The study found that leukemia free survival from IL-2 monotherapy is
similar to that of current standard of care, while the benefit of
Ceplene® +IL-2 over standard of care and IL-2 monotherapy is
statistically significant. Researchers stated the conclusion reached was
robust with respect to the modeling assumptions. This study helped
reinforce the consensus that a further clinical trial that utilizes IL-2
monotherapy is not ethical or feasible. The poster “Incremental Benefit
of Histamine Dihydrochloride When Added to Interleukin-2 for Remission
Maintenance in Acute Myeloid Leukemia: A Bayesian Meta-analysis” was
authored by Scott M. Berry, PhD and Kristine R. Broglio, MS, Berry
Consultants, LLC, College Station, TX; Donald A. Berry, PhD, Berry
Consultants, LLC and Division of Quantitative Sciences, The University
of Texas M.D. Anderson Cancer Center, Houston, TX.

“We were very pleased by the positive response we received at ASH from
numerous key opinion leaders in hematology in the U.S., both on the
results of the meta-analysis as well as on the potential of Ceplene® to
profoundly impact the standard of care for AML if approved,” said Jack
Talley, President and CEO of EpiCept. “We are encouraged by the results
of the new analysis we generated from the earlier Phase III Ceplene®
trial and believe that we have a clear and achievable regulatory path
for Ceplene®. A successful outcome from the planned U.S. survival trial
for Ceplene® would, in our view, establish Ceplene® as a cornerstone of
remission maintenance therapy in the U.S.”

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®, 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 two 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
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 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 EpiCept™ NP-1 or
crolibulinTM will not be successful, the risk that EpiCept™ NP-1 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 EpiCept™ NP-1 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 (http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%
2F%2Fus.lrd.yahoo.com%2F_ylt%3DAgfqFPfVOEK5M4_Rv8aJvhTjba9_%3B_ylu%3DX3o
DMTEzM2pvaWgxBHBvcwMyBHNlYwNuZXdzYXJ0Ym9keQRzbGsDd3d3c2VjZ292%2FSIG%3D15
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k%2526url%3Dhttp%25253A%25252F%25252Fwww.sec.gov%2526esheet%3D6170045%25
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x=1&md5=6e2df6b1f995c5c800575fa48d8396c0) 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
SIG%3D1659oglun%2F**http%253A%2Fcts.businesswire.com%2Fct%2FCT%253Fid%3D
smartlink%2526url%3Dhttp%25253A%25252F%25252Fwww.epicept.com%2526esheet%
3D6170045%2526lan%3Den_US%2526anchor%3Dwww.epicept.com%2526index%3D3%252
6md5%3D8b3a48c3367e26fcfbd15295b6d82118&esheet=6541136&lan=en-US&anchor=
www.epicept.com&index=2&md5=b95eee108dd85920c2aba4d1943559d3). 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 (rcook@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)