EpiCept Releases New Data Demonstrating Long-Term Durability of Ceplene in Sustaining Leukemia-Free Survival


EpiCept Releases New Data Demonstrating Long-Term Durability of Ceplene in
Sustaining Leukemia-Free Survival 

Data to Be Presented at the European Hematology Association's 14th Congress 

TARRYTOWN, N.Y.--(BUSINESS WIRE)-- EpiCept Corporation (Nasdaq and OMX Nordic
Exchange: EPCT) has released new long-term data showing that the use of Ceplene®
when administered in conjunction with low-dose interleukin-2 (IL-2) provides
durable protection from leukemia relapse in patients with Acute Myeloid Leukemia
(AML), based on a minimum of six years of follow-up. These data will be
presented on June 6, 2009 at the European Hematology Association's (EHA) 14th
Congress in Berlin, Germany. 

The presentation entitled “Six-Year Outcomes Update from a Randomized Phase 3
Trial in AML: Durable Effect of Remission Maintenance Immunotheraphy with
Histamine Dihydrochloride and low-dose IL-2” was authored by Dr. Mats Brune, MD
and co-workers. 

Researchers analyzed follow-up data from patients enrolled in the Phase III
pivotal trial of Ceplene®. The primary endpoint assesses the durability of the
benefit of Ceplene® with IL-2 in achieving leukemia-free-survival (LFS), after a
minimum of six years, in patients who have achieved first complete remission
(CR1) and among the overall patient group. The study found that the
Ceplene®/IL-2 treatment group continued to show statistically significant
differences in LFS in the overall treatment population (p=0.011) and among the
CR1 group (p=0.015). 

“These data provide further demonstration of the positive and prolonged clinical
benefits Ceplene® can provide AML patients in preventing relapse of this deadly
disease,” remarked Jack Talley, President and CEO of EpiCept. “These findings
also represent the latest in a number of significant milestones for Ceplene®, as
we just announced that the drug is now available to patients in major markets
throughout the world through our named patient program agreement with IDIS. We
continue to be keenly focused on further expanding the extraordinary impact that
Ceplene® can have on AML patients through our regulatory advancement of the drug
in North America.” 

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 risk that we will not have sufficient authorized shares of stock to raise
equity capital, 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 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 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
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 

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