EpiCept Provides Clinical and Business Update on Ceplene Program

EpiCept Provides Clinical and Business Update on Ceplene Program 

Announces New Initiatives to Expand Label, Drive Product Adoption 

TARRYTOWN, N.Y.--(BUSINESS WIRE)--EpiCept Corporation (Nasdaq and OMX Nordic
Exchange: EPCT) today provided an update on new clinical developments and other
initiatives related to Ceplene® (histamine dihydrochloride), the Company's
therapy approved in the European Union for the remission maintenance and
prevention of relapse of patients with acute myeloid leukemia (AML) in first
remission. 

EpiCept announced plans to initiate two new studies for Ceplene and provided an
update on another study for Ceplene intended to help achieve an expanded
indication and broaden use for the drug. These studies include: 

A Phase I/II study that will research the effects of a regimen of Ceplene and
low-dose interleukin-2 (IL-2) in combination with Gleevec® (imatinib mesylate)
on the eradication of minimal residual disease (MRD) in adult patients with
chronic myeloid leukemia. The study will be led by the Nordic Chronic Myeloid
Leukemia Study Group (NCMLSG), which is comprised of physicians and researchers
in Sweden, Denmark, Norway and Finland. The primary objective of the study will
be to assess the safety of the combination therapy of Ceplene/IL-2 with Gleevec
given for six months and to assess the number of patients achieving and
subsequently maintaining disease-free survival after discontinuation of Gleevec.
Patients will be followed for a minimum of 18 months after discontinuation of
Gleevec therapy. MRD will be followed using a specific market resulting from a
chromosomal abnormality found in CML.

The initiation of a study led by GFM (Groupe Francophone des Myélodysplasies)
that will examine the effects of Ceplene/IL-2 in combination with Vidaza®
(azacitidine) in the treatment of patients with higher risk myelodsyplastic
syndromes (MDS), a bone marrow disease that can progress to AML. These patients
will already have demonstrated a hematological response to Vidaza. This trial
will be followed by a randomized Phase II study of the efficacy, safety and
tolerability of the addition of Ceplene/IL-2 to Vidaza compared to Vidaza alone
in patients with higher risk MDS and who have achieved hematological response to
Vidaza.

The post-approval clinical study of Ceplene initiated in July 2009 that is
studying the effects of remission maintenance therapy with Ceplene/IL-2 on MRD
in adult patients with AML in first complete remission. This open-label,
multicenter study will also assess the quantitative and qualitative
pharmacodynamic effects of Ceplene/IL-2 on these patients by monitoring T and
natural killer cell phenotypes and their functionality after the first and third
treatment cycles. Enrollment in this study is ongoing and the 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.

EpiCept also announced today that the first meeting of the Scientific Advisory
Board (SAB) it established in collaboration with the European LeukemiaNet
Foundation took place on November 18, 2009. The SAB, comprised of 10 key opinion
leaders in AML and who collectively practice in all of the major countries in
the European Union, gathered to formulate strategies to increase physician
awareness and education of the benefits of Ceplene in treating AML patients in
Europe. As an outcome of that meeting, SAB members have committed to help
facilitate physician access to and use of Ceplene in AML and hematologic
disease. 

EpiCept had a commercial presence at both the European Hematology Association
earlier this year and at the American Society of Hematology meeting in December.
The company intends to continue and expand upon these efforts in 2010 in
conjunction with a European partner, as appropriate, to facilitate the
commercial launch of Ceplene. 

“We believe that positive results from either the trial of Ceplene in MDS with
Vidaza or Ceplene in CML with Gleevec would indicate a potentially significant
public health benefit from the use of Ceplene in combination with these
currently marketed drugs, and provide an important pathway for expanding the
label for Ceplene and its future market potential,” remarked Jack Talley,
President and Chief Executive Officer of EpiCept. “These trials, along with the
efforts of our SAB, are increasing Ceplene's exposure to physicians in Europe
and educating them on its proper use and administration. We believe these
efforts will provide significant rewards for EpiCept in the future as we work
towards finalizing a commercial partnership agreement for this life-saving
medicine.” 

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, 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 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 Ceplene will not be
launched 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 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 EpiCept 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 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 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 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 

*Gleevec is a registered trademark of Novartis Pharmaceuticals. 

*Vidaza is a registered trademark of Celgene Corporation. 

*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