EpiCept Releases New Data Demonstrating Prolonged Five-Year Leukemia-Free
Survival for AML Patients Treated with Ceplene(TM) + IL-2
First Drug Regimen Shown to Prevent AML Relapse
TARRYTOWN, N.Y., Dec. 10 /PRNewswire/ -- EpiCept Corporation (Nasdaq and OMX
Nordic Exchange: EPCT) today released new clinical data that demonstrate a
durable improvement in leukemia-free survival (LFS) over five years among Acute
Myeloid Leukemia (AML) patients who receive
post-consolidation immunotherapy
with Ceplene(TM) (histamine dihydrochloride) in conjunction with low dose
interleukin-2 (IL-2). These data were presented on December 9th at the 49th
Annual Meeting of the American Society of Hematology (ASH) in Atlanta.
(Logo: http://www.newscom.com/cgi-bin/prnh/20020513/NYM112LOGO )
Ceplene is EpiCept's registration stage product candidate for the remission,
maintenance and prevention of relapse of patients with AML in first remission,
and is currently under late stage review by the European Medicines Evaluation
Agency (EMEA).
"These important findings add to the growing body of evidence demonstrating that
the combination of Ceplene and low-dose IL-2 is the first drug regimen capable
of prolonging leukemia-free survival and preventing relapse among AML patients
in first remission," remarked Jack Talley, President and CEO of EpiCept. "While
the Phase III study of Ceplene was powered to show a leukemia-free survival
benefit over 36 months, these additional data provide confirmation of a lasting
leukemia-free benefit for at least five years. We are continuing to work closely
with regulators in Europe on our Marketing Authorization Application for Ceplene
and remain on track to receive a final decision by the European Commission
during the first half of 2008."
Mats L. Brune, MD, Medical Director of the Bone Marrow Transplant Program at the
University of Goteborg delivered the findings in a poster presentation entitled,
"Post-consolidation Immunotherapy with Histamine Dihydrochloride and
Interleukin-2 in AML: Long Term Follow-Up of Leukemia-Free Survival and Overall
Survival."
The data were derived from an analysis of the long-term outcomes of AML patients
enrolled in the pivotal Phase III Ceplene study, which met its primary endpoint
of increased LFS (p <0.01) among AML patients in remission. The objective of the
five-year analysis was to assess the durability of the LFS benefit of
post-consolidation immunotherapy with Ceplene + IL-2.
The median LFS of AML patients in first remission was 15 months for the Ceplene
+ IL-2 group versus 9.7 months in the control group (P=0.025). A Kaplan-Meier
five-year estimate was supportive of the effect of Ceplene + IL-2 in maintaining
LFS. In the AML population in first remission, this effect was shown in 34
percent of the treatment group versus 22 percent of the control group (P=0.024).
Further, the median duration of the overall survival rate in the first remission
patient group was 44 months for the Ceplene + IL-2 group versus 29 months for
the control group, an improvement of 15 months. The Kaplan-Meier estimate
analysis of patients alive at five years show a strong trend in favor of Ceplene
+ IL-2 (Kaplan-Meier, P=0.07), even though the trial was not initially powered
to demonstrate a benefit in overall survival.
Dr. Brune stated, "The effect of a combined therapy of Ceplene + IL-2 in
prolonging leukemia-free survival and in preventing relapse was both durable and
statistically significant. These results indicate that Ceplene, if approved,
could provide important therapeutic benefits to AML patients, for whom there are
currently no available treatment options shown to increase leukemia-free
survival."
Additional Ceplene Study Results Presented
In a separate poster presentation given yesterday at ASH, EpiCept provided new
study results regarding the mechanisms of action relevant to Ceplene's
demonstrated ability in combination with IL-2, to prevent leukemic relapse among
AML patients. These data were presented by Ana I. Romero from the Department of
Internal Medicine, University of Goteborg in a presentation entitled, "Histamine
Dihydrochloride Maintains Cytoxic Effector T Lymphocyte Function and Viability
under Conditions of Oxidative Stress."
In the study, researchers recovered autoreactive T-cells from AML patients and
exposed them to exogenous hydrogen peroxide or oxygen radical-producing
mononuclear phagocytes. Ceplene, an inhibitor of oxygen radical formation in
phagocytes, completely prevented apoptosis in the T-cell subset (n=8, p<0.0001).
In the presence of mononuclear phagocytes, Ceplene synergized with IL-2 in
promoting cell cycle proliferation. Based on these findings, researchers
concluded that the phenotype of T-cells with spontaneous reactivity against AML
blasts is highly sensitive to oxidants and that by inhibiting oxygen radical
formation, Ceplene efficiently protects these cytotoxic lymphocytes from
apoptosis in an environment of oxidative stress. In addition, Ceplene was shown
to synergize with IL-2 to activate and expand these T-cells.
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.
Ceplene Clinical Trial History
A pivotal Phase III study for Ceplene in conjunction with IL-2 was conducted in
11 countries and included 320 randomized patients. This study met its primary
endpoint of preventing relapse as shown by increased LFS at three years for AML
patients in remission. The data demonstrated that patients with AML in complete
remission who received 18 months of treatment with Ceplene plus low dose IL-2
experienced a significantly improved LFS compared with the current standard of
care, which is no treatment after successful induction of remission. The
improvement in LFS achieved by Ceplene + IL-2 was highly statistically
significant at three years (p=0.0096, analyzed according to Intent-to-Treat).
In patients in their first remission, there was a 55 percent improvement in LFS.
This represented an absolute improvement of more than 22 weeks in terms of
delayed progression of the disease. This benefit was highly statistically
significant, (p=0.011). This is the intended patient population for the
Marketing Authorization Application submitted for Ceplene in Europe. The results
of this trial were published in "Blood," a leading scientific journal in
hematology, (Blood; The Journal of the American Society of Hematology, volume
108, number 1, July 1, 2006).
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(TM) 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- 12/10/2007
/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 /
(EPCT)
EpiCept Releases New Data Demonstrating Prolonged Five-Year Leukemia-Free Survival for AML Patients Treated with Ceplene(TM) + IL-2
| Source: Immune Pharmaceuticals Inc
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