EpiCept Identifies Ceplene® Survival Benefit in Key AML Subgroup

EpiCept Identifies Ceplene® Survival Benefit in Key AML Subgroup

Files New Patent Applications for Ceplene® in AML of Monocyte Origin

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

EpiCept Corporation (Nasdaq and Nasdaq OMX Stockholm Exchange: EPCT)
today announced the Company has identified a statistically significant
survival benefit in a subgroup of Acute Myeloid Leukemia (AML) patients
in its previous Phase III trial with Ceplene® (histamine
dihydrochloride) administered with low-dose interleukin-2 (IL-2). The
identification of this subgroup is expected to influence the design of
the protocol for a new Phase III trial to support resubmission of a New
Drug Application (NDA) with the U.S. Food and Drug Administration (FDA).
Ceplene® is approved in the European Union and Israel for the remission
maintenance and prevention of relapse in adult patients with AML in
first remission.

In October 2010 EpiCept reached an agreement with the FDA on a
regulatory path for a resubmission of the Ceplene® NDA. Under the
agreement, EpiCept intends to undertake a new confirmatory clinical
trial to demonstrate Ceplene®'s benefit with overall survival as the
primary endpoint.

As part of its clinical trial protocol preparations for the Ceplene®
pivotal study, EpiCept conducted an additional analysis of AML subgroups
from its previous Phase III study of Ceplene®. While that study was not
powered to determine overall survival, EpiCept's analysis has identified
that patients with AML of monocyte origin achieved a statistically
significant increase in overall survival after treatment with Ceplene®
plus low-dose IL-2. Furthermore, this analysis identified a strong
correlation between the administration of high-intensity consolidation
treatment, and improvements in overall survival.

EpiCept has applied these findings in the development of the clinical
trial protocol and is currently reviewing the protocol with key opinion
leaders in hematology. The Company expects to submit this protocol to
the FDA in the second quarter of 2011, following which the FDA, via the
Special Protocol Assessment procedure, will provide guidance on specific
sections of the protocol. Based on this anticipated schedule, EpiCept
expects to initiate the trial in the second half of 2011.

EpiCept also announced that it has submitted additional U.S. and global
patent applications based on the discoveries of the efficacy of Ceplene®
plus IL-2 in AML of monocyte origin. The Company believes that these
provisional patents, if granted, would provide an additional 20 years of
market exclusivity for Ceplene® from the date of patent filing.

About Ceplene®

Ceplene® is approved in the European Union and Israel and is indicated
for remission maintenance therapy and prevention of relapse in adult
patients with AML, one of four types of leukemia. Ceplene® is used
together with low-dose Interleukin-2. The prevalence for AML in the EU
is about 41,000 patients and more than 16,000 new cases are diagnosed
every year. While current induction and consolidation treatments are
successful in inducing complete remission for the majority of AML
patients, this remission is generally short-lived. After achieving
complete remission most patients will suffer a relapse within one year.
In an international, multicenter, open-label, randomized Phase III
study, Ceplene® met its primary endpoint of prolonging leukemia-free
survival for AML patients in first remission. The difference between the
treated and control group was highly statistically significant
(p<0.008). Recently completed subset analyses of patients in the Phase
III trial determined that patients with AML of monocyte origin achieved
a statistically significant increase in overall survival after treatment
with Ceplene® plus low-dose IL-2 and identified a strong correlation
between the administration of high-intensity consolidation treatment and
improvements in overall survival, suggesting that statistically
significant improved overall survival could be achieved in a well
designed and adequately powered clinical trial.

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 EU and Israel for
the remission maintenance and prevention of relapse in adult patients
with 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 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 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 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
DMTEzM2pvaWgxBHBvcwMyBHNlYwNuZXdzYXJ0Ym9keQRzbGsDd3d3c2VjZ292%2FSIG%3D15
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k%2526url%3Dhttp%25253A%25252F%25252Fwww.sec.gov%2526esheet%3D6170045%25
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44301e411e3335754ee5c07&esheet=6633129&lan=en-US&anchor=www.sec.gov&inde
x=1&md5=37e35868443400c5b557f24922a522f2) 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=6633129&lan=en-US&anchor=
www.epicept.com&index=2&md5=0b4f38fac3725f366ceb2da0078264bb). 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)