EpiCept Files Protocol with FDA for Ceplene® Phase III Confirmatory Trial

EpiCept Files Protocol with FDA for Ceplene® Phase III Confirmatory
Trial

SPECIAL PROTOCOL ASSESSMENT WILL FACILITATE NDA SUBMISSION

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

EpiCept Corporation (Nasdaq and Nasdaq OMX Stockholm: EPCT) announced
today that it has filed a protocol for a Phase III confirmatory clinical
trial for Ceplene® (histamine dihydrochloride) with the U.S. Food and
Drug Administration (FDA). The protocol will be reviewed under the FDA's
Special Protocol Assessment (SPA) program under which the FDA will
provide formal guidance regarding the trial's design, clinical
endpoints, statistical analysis and labeling claims. EpiCept expects to
receive initial comments from the FDA within the next 45 days, and to
reach an agreement with the FDA on all major protocol elements later
this year. Ceplene is EpiCept's maintenance therapy for patients with
acute myeloid leukemia (AML) in first remission and is currently
approved in the European Union and Israel.

As part of this submission, EpiCept has proposed a two-arm trial
comparing the efficacy of maintenance therapy with Ceplene in
conjunction with low-dose interleukin-2 (IL-2) to investigator's choice,
which is often no treatment. The target population is AML patients in
first complete remission (CR1) who have received consolidation therapy.
The primary endpoint will be overall survival. In the proposed protocol,
patients in the control arm may, at the discretion of the study
investigator, be offered some form of maintenance therapy. EpiCept
believes that offering patients in the control arm the possibility of
alternative medical interventions should benefit patient recruitment and
enrollment although most patients are expected to receive no therapy,
which is the current standard of care.

The proposed study design is based on input and guidance EpiCept
received from the FDA during a meeting in October 2010. In addition, to
ensure that the study design was both clinically rigorous and feasible
from an enrollment standpoint, EpiCept worked closely with key opinion
leaders to develop the protocol. The Company plans to provide more
detailed information regarding the protocol design upon securing
agreement with the FDA.

Key differences in this proposed study from the earlier pivotal study of
Ceplene/IL-2 conducted by the Company are:

  · Only CR1 patients will be enrolled;
  · Overall survival instead of leukemia free survival will be the
primary endpoint;
  · Pre-specified intervals for bone marrow examinations will more
closely track relapse as a secondary endpoint in the trial;
  · Patients will be randomized into the trial earlier following
hematologic recovery than the previous trial; and
  · More intensive consolidation therapy will be required.

EpiCept expects that these changes will likely lead to a favorable
outcome in the trial, assuming FDA agreement with these criteria.

The Company believes the results of this Phase III study, if positive,
will provide the basis for the filing of a New Drug Application for
Ceplene in the U.S.

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 IL-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 European Union and
several other countries for the remission maintenance and prevention of
relapse in adult patients with Acute Myeloid Leukemia (AML) in first
remission. In the United States, the Phase III 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 AmiKet™ (formerly known as 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 our securities may be delisted
from The Nasdaq Capital Market; 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 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 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
AmiKet™ or crolibulinTM will not be successful, the risk that AmiKet™ 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 AmiKet™ 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 (http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%
2F%2Fus.lrd.yahoo.com%2F_ylt%3DAgfqFPfVOEK5M4_Rv8aJvhTjba9_%3B_ylu%3DX3o
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x=1&md5=f2547082a172bae385b0561d23070943) 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
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smartlink%2526url%3Dhttp%25253A%25252F%25252Fwww.epicept.com%2526esheet%
3D6170045%2526lan%3Den_US%2526anchor%3Dwww.epicept.com%2526index%3D3%252
6md5%3D8b3a48c3367e26fcfbd15295b6d82118&esheet=6716402&lan=en-US&anchor=
www.epicept.com&index=2&md5=7a149c14f93c916d289a6352a2605b09). 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)