EpiCept Receives Initial FDA Comments on Application for Ceplene® Special Protocol Assessment

EpiCept Receives Initial FDA Comments on Application for Ceplene®
Special Protocol Assessment

 

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

EpiCept Corporation (Nasdaq and Nasdaq OMX Stockholm Exchange: EPCT)
today announced that it has received initial written responses from the
U.S. Food and Drug Administration (FDA) regarding the Company's
application for a Special Protocol Assessment (SPA) of the Ceplene®
(histamine dihydrochloride) Phase III protocol. Ceplene, which is
administered in conjunction with low-dose interleukin-2 (IL-2), is
EpiCept's maintenance therapy for patients with acute myeloid leukemia
(AML) in first remission. Among those responses, the FDA noted that in
contrast to its earlier position it is now proposing that the trial
attempt to isolate Ceplene's effect by including an IL-2 monotherapy arm
in the trial protocol. The FDA has invited the Company to request a
meeting to discuss its responses to the Company's application.

In its initial protocol submission, EpiCept proposed a two-arm trial
comparing the efficacy of maintenance therapy with Ceplene in
conjunction with IL-2 to investigator's choice, which is often no
treatment.

EpiCept intends to meet with the FDA as soon as possible to reconcile
this response with the position taken at its meeting with the Company in
October 2010 in which an IL-2 monotherapy arm was not part of the
agreed-upon trial design, and to discuss other responses to the SPA
application. The Company retains the right to appeal any decision by the
FDA's Office of Oncology Drug Products.

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 EU and Israel for
the remission maintenance and prevention of relapse in adult patients
with AML in first remission. The Company has two other oncology drug
candidates 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 risks associated with our ability to
continue to meet our obligations under our existing debt agreements, the
risk that our application to change our listing status on the Nasdaq OMX
Stockholm Exchange may not be approved, 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 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 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; 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=6774058&lan=en-US&anchor=www.sec.gov&inde
x=1&md5=707bd4399d404a79bfb1139195e21bd1) 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=6774058&lan=en-US&anchor=
www.epicept.com&index=2&md5=97860b60332e9772d8b5ac7192b11a05). 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)