EpiCept Corporation and FDA Agree on Development Plan for Ceplene®

EpiCept Corporation and FDA Agree on Development Plan for Ceplene®

Phase III Trial to be Conducted under a Special Protocol Assessment

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

EpiCept Corporation (Nasdaq and Nasdaq OMX Stockholm Exchange: EPCT)
today announced that it has reached an agreement on all outstanding
issues with the U.S. Food and Drug Administration (FDA) on a regulatory
path forward for Ceplene® (histamine dihydrochloride), the Company's
lead product for the remission maintenance and prevention of relapse of
patients with acute myeloid leukemia (AML) in first complete remission.
Ceplene® is approved in the European Union for this indication and is
marketed there by Meda AB.

The FDA indicated that a new trial should be conducted to demonstrate
Ceplene's activity in conjunction with low-dose interleukin-2 (IL-2) as
remission maintenance therapy for AML patients in first complete
remission. EpiCept has reached agreement with the FDA for a two-arm,
randomized, open-label trial that will compare the efficacy of Ceplene®
plus low-dose IL-2 to standard of care in this indication. Based on FDA
guidance, the primary endpoint of the trial will be overall patient
survival. The Company's previous Phase III trial demonstrated a
statistically significant prolongation of the primary endpoint of
leukemia-free survival and extended overall survival by more than one
year in patients in their first complete remission.

As a next step, EpiCept will submit a detailed Phase III protocol. The
FDA, via the Special Protocol Assessment (SPA) procedure, will provide
guidance on specific sections of the protocol including the adaptive
design with prospectively defined rules for sample size selection for
both futility and expected success. The Company also recently filed an
application with the FDA to grant Ceplene® fast track status. In
addition to other benefits, if granted, this should permit an expedited
review of the Ceplene® New Drug Application (NDA) once it is filed.

“We are committed to Ceplene® as an important medical breakthrough that
needs to be available to AML patients in the United States as it is
currently in Europe,” said Jack Talley, President and Chief Executive
Officer of EpiCept. “We intend to work closely with the FDA to produce
an optimal trial design that is achievable and can be conducted in a
reasonable timeframe. The framework under which we are working with the
FDA provides us with a realistic pathway to conduct the study ourselves
or with a partner. We will now determine the appropriate next steps for
funding and conducting this trial, with the intent of commencing such a
study in 2011.”

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 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 EpiCeptTM 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
t064n6f%2F**http%253A%2Fcts.businesswire.com%2Fct%2FCT%253Fid%3Dsmartlin
k%2526url%3Dhttp%25253A%25252F%25252Fwww.sec.gov%2526esheet%3D6170045%25
26lan%3Den_US%2526anchor%3Dwww.sec.gov%2526index%3D2%2526md5%3D61ec7b720
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x=1&md5=25d0beb7f4f76ae9d54482a4afd578af) 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=6486887&lan=en-US&anchor=
www.epicept.com&index=2&md5=290365a9641c86ead285180fd93ab943). 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)