EpiCept Initiates Post-Approval Clinical Study with Ceplene®

Further Evidence of Efficacy for Ceplene ® in Patients with AML Will Be Assessed
by Measuring Biomarkers and Minimal Residual Disease
TARRYTOWN, N.Y.--(Business Wire)--
Regulatory News:

EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) today announced the
start of a post-approval clinical study with Ceplene® (histamine
dihydrochloride) following Ethics Committee and Competent Authority approvals in
Sweden, Belgium, and France. This study will fulfill the post approval
commitments requested by the European Medicines Evaluation Agency (EMEA) in
granting marketing authorization. Ceplene® is indicated for remission
maintenance in adult patients with Acute Myeloid Leukemia (AML) in first
remission. Ceplene®is to be administered in conjunction with low-dose
interleukin-2 (IL-2).

This study will enroll up to 150 patients at approximately 25 centers across
Europe with sites in Sweden, Belgium, France, the U.K., Spain and Italy. The two
primary objectives are to further demonstrate the clinical pharmacology of
Ceplene® by assessing certain immunologic biomarkers in AML patients in first
remission, and to measure the effect of Ceplene®/IL-2 on minimal residual
disease in the same patient population. Secondary objectives will assess
leukemia-free survival after a follow-up period of up to two years. EpiCept
expects the study will take approximately three years to complete.

"We are pleased to begin this study under the leadership of study chair and
principal investigator Dr. Robin Foa in Rome, Italy and co-principal
investigator Dr. Mats L. Brune in Gothenburg, Sweden and to be working closely
with a broad network of hematology thought leaders," stated Jack Talley,
President and Chief Executive Officer of EpiCept. "The commencement of this
trial meets our post-approval commitment to the EMEA and underscores our
determination to move forward as quickly as possible with the commercial launch
of the drug in the European Union. Ceplene® is an important therapy for AML
patients because it is the only medical therapy ever proven to prevent relapse
in this deadly disease."

About Ceplene®

Ceplene®is EpiCept's proprietary product approved in the European Union for
maintenance therapy for adult patients with AML in first remission. Ceplene® is
designed to protect lymphocytes responsible for immune-mediated destruction of
residual leukemic cells. Laboratory research has demonstrated that Ceplene®
reduces formation of oxygen radicals from phagocytes, inhibiting NADPH oxidase
and protecting IL-2-activated NK-cells and T-cells. In October 2008 Ceplene®
received full marketing approval in the European Union for maintenance therapy
and prevention of relapse in adult patients with AML in first remission.

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 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
EpiCeptTM 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, 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 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 be launched in Europe in the second
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
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 our securities may be delisted by The Nasdaq Capital Market 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
United States or Canada, 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 EpiCeptTM NP-1 or crinobulin will not be
successful, the risk that EpiCeptTM NP-1 or crinobulin 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
EpiCeptTM 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; 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.

EPCT-GEN

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

EpiCept Corporation:
Robert W. Cook, 914-606-3500
mail@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

Copyright Business Wire 2009