EpiCept Announces Presentation of New Ceplene(TM) Data at the 49th Annual
Meeting of the American Society of Hematology
TARRYTOWN, N.Y., Dec. 4 --
EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) today announced
that it will be presenting new clinical data for Ceplene (histamine
dihydrochloride) at the upcoming 49th Annual Meeting of the American Society of
Hematology (ASH), taking place in Atlanta, Georgia from December 8-11, 2007.
Ceplene is EpiCept's lead oncology product candidate under late stage review by
the European Medicines Evaluation Agency (EMEA) for the remission maintenance
treatment and prevention of relapse of patients with Acute Myeloid Leukemia
(AML) in first remission.
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The results to be presented at the meeting include an analysis of the
long-term outcomes of AML patients enrolled in the pivotal Phase III Ceplene
study. The new data compares the effects of post-consolidation immunotherapy
with histamine dihydrochloride (HDC) in conjunction with low dose interleukin-2
(IL-2) on leukemia-free survival and overall survival compared to the current
standard of care, which is no treatment, at five years post initiation of
therapy.
The following poster presentations will be given by EpiCept on Sunday,
December 9, 2007 from 9:00 a.m. to 8:00 p.m. Eastern Time at Hall B3 and B4 in
the Georgia World Congress Center.
Poster # 36
Title: "Post-consolidation Immunotherapy with Histamine Dihydrochloride
and Interleukin-2 in AML: Long Term Follow-Up of Leukemia-Free Survival
and Overall Survival."
Session Name: Acute Myeloid Leukemias - Therapy, excluding
Transplantation.
Presenter: Mats L. Brune, et al; University of Goteborg, Goteborg,
Sweden.
Poster # 499
Title: "Histamine Dihydrochloride Maintains Cytoxic Effector Lymphocyte
Function and Viability under Conditions of Oxidative Stress."
Session Name: Lymphocytes, Natural Killer, and Dendritic Cells II.
Presenter: Ana I. Romero, et al.; University of Goteborg, Goteborg,
Sweden.
A third abstract developed by EpiCept investigators entitled "Impact on
Quality of Life of Postconsolidation Immunotherapy with Histamine
Dihydrochloride and Interleukin-2 in Acute Myelogenous Leukemia" appeared in
the November edition of Blood, The Journal of The American Society of
Hematology. This paper demonstrated that patients treated with Ceplene in
conjunction with low dose interleukin-2 had an equivalent quality of life
compared to the current standard of care, which is no treatment, in the pivotal
trial.
EpiCept also announced today that it is providing an educational grant in
support of a CME-certified Symposium for clinicians and scientists specializing
in hematology and oncology entitled "Improving Outcomes in Acute Myeloid
Leukemia." The event will take place on Friday, December 7, 2007 beginning at
7:00 p.m. in Room B211-212, Building B, Level 2 at the Georgia World Congress
Center in Atlanta, Georgia. Additional information on the Symposium is
available at www.dwrite.com/ASH2007.
About Ceplene
Ceplene is EpiCept's registration-stage compound for the treatment of AML.
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.
About EpiCept Corporation
EpiCept is focused on unmet needs in the treatment of pain and cancer. The
Company's broad portfolio of pharmaceutical product candidates includes several
pain therapies in clinical development and a lead oncology compound for AML
with demonstrated efficacy in a Phase III trial; a marketing authorization
application for this compound is approaching a decision in Europe. In
addition, EpiCept's ASAP technology, a proprietary live cell high-throughput
caspase-3 screening technology, can efficiently identify new cancer drug
candidates and molecular targets that selectively induce apoptosis in cancer
cells. Two oncology drug candidates currently in clinical development that
were discovered using this technology have also been shown to act as vascular
disruption agents in a variety of solid tumors.
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
EpiCept's 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 EU or that
Ceplene, if approved, will not achieve significant commercial success, the risk
that our NP-1 clinical trials will not be successful, that NP-1 will not
receive regulatory approval or achieve significant commercial success, the risk
that Myriad's development of Azixa(TM) 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 our ASAP technology
will not yield any successful product candidates, the risk that clinical trials
for EPC 2407 will not be successful, that EPC 2407 will not receive regulatory
approval or achieve significant commercial success, 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 EpiCept will not obtain approval to market any
of its product candidates, the risks associated with our need to raise
additional financing to continue to meet our capital needs and our ability to
continue as a going concern, 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; competition; litigation; risks associated with prior material
weaknesses in our internal controls; and risks associated with our ability to
protect our intellectual property. These factors and other material risks are
more fully discussed in EpiCept's periodic reports, including its 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 EpiCept's 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.
SOURCE EpiCept Corporation
-0- 12/04/2007
/CONTACT: Robert W. Cook of EpiCept Corporation, +1-914-606-3500,
rcook@epicept.com; Media, Greg Kelley of Feinstein Kean Healthcare,
+1-617-577-8110, gregory.kelley@fkhealth.com; Investors, Kim Sutton Golodetz,
+1-212-838-3777, kgolodetz@lhai.com or Bruce Voss, +1-310-691-7100,
bvoss@lhai.com, both of Lippert-Heilshorn & Associates/
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/Web site: http://www.epicept.com
http://www.dwrite.com/ASH2007 /
(EPCT)
EpiCept Announces Presentation of New Ceplene(TM) Data at the 49th Annual Meeting of the American Society of Hematology
| Source: Immune Pharmaceuticals Inc