EpiCept Corporation Provides U.S. Regulatory Update for Ceplene® Clinical Development

EpiCept Corporation Provides U.S. Regulatory Update for Ceplene®
Clinical Development

 

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

EpiCept Corporation (Nasdaq OMX Stockholm Exchange and Nasdaq: EPCT)
today announced that at a recent meeting with the U.S. Food and Drug
Administration (FDA) the Company was provided more definitive guidance
regarding the clinical development of Ceplene® (histamine
dihydrochloride), the Company's lead product administered with
interleukin-2 (IL-2) for the remission maintenance and prevention of
relapse of patients with acute myeloid leukemia (AML) in first complete
remission. Ceplene® is approved and being marketed in the European Union
by Meda AB and in Israel by Megapharm, Ltd.

At the meeting, the FDA indicated that as part of a registration study,
the effect of Ceplene® must be isolated from the effect of IL-2;
therefore the preferred study design will be a comparison of
Ceplene®/IL-2 vs. IL-2 monotherapy. Furthermore, the FDA recommended
that the patients in the IL-2 monotherapy group receive the same IL-2
dosing regimen as those patients receiving Ceplene®/IL-2 in combination.
The FDA reiterated the need to demonstrate a significant benefit of
Ceplene®/IL-2 vs. IL-2 monotherapy on overall survival, which needs to
be the primary endpoint of the trial. Leukemia-free survival (LFS) can
be a secondary endpoint provided that bone marrow samples are collected
at pre-specified and regular intervals during the course of the trial.

EpiCept intends to work with key opinion leaders in the preparation of a
new trial protocol and will submit the protocol to the FDA in order to
receive further guidance and approval for Special Protocol Assessment as
soon as possible.

EpiCept President and CEO Jack Talley commented, “We appreciate the
input received from the FDA, which outlined a clear path for the
registration of Ceplene® in the U.S. We will incorporate the FDA's
feedback in the design of a new pivotal clinical study with appropriate
treatment arms and endpoints, such that, assuming a positive trial
result, only one new pivotal study will be sufficient to support the
submission of a new drug application.”

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 AmiKet™, 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 AmiKet™ or crolibulinTMwill not be successful, the risk that AmiKet™
or crolibulinTMwill 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; 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
44301e411e3335754ee5c07&esheet=6857149&lan=en-US&anchor=www.sec.gov&inde
x=1&md5=d96a083e72923a85eb210a8f6cc99845) 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=6857149&lan=en-US&anchor=
www.epicept.com&index=2&md5=aad1d8c54bd24350862221f137a52997). 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:
LHA
Kim Sutton Golodetz, 212-838-3777
kgolodetz@lhai.com (kgolodetz@lhai.com)
or
Bruce Voss, 310-691-7100
bvoss@lhai.com (bvoss@lhai.com)