Regulatory News:
EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) today
announced the start of a post-approval clinical study with Ceplene® (histamine
dihydrochloride) following Ethics Committee and Competent Authority
approvals in Sweden, Belgium, and France. This study will fulfill the
post approval commitments requested by the European Medicines Evaluation
Agency (EMEA) in granting marketing authorization. Ceplene®
is indicated for remission maintenance in adult patients with Acute
Myeloid Leukemia (AML) in first remission. Ceplene®is to be
administered in conjunction with low-dose interleukin-2 (IL-2).
This 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. The two primary objectives are to further demonstrate the
clinical pharmacology of Ceplene® by assessing certain
immunologic biomarkers in AML patients in first remission, and to
measure the effect of Ceplene®/IL-2 on minimal residual
disease in the same patient population. Secondary objectives will assess
leukemia-free survival after a follow-up period of up to two years.
EpiCept expects the study will take approximately three years to
complete.
"We are pleased to begin this study under the leadership of study chair
and principal investigator Dr. Robin Foa in Rome, Italy and co-principal
investigator Dr. Mats L. Brune in Gothenburg, Sweden and to be working
closely with a broad network of hematology thought leaders,” stated Jack
Talley, President and Chief Executive Officer of EpiCept. "The
commencement of this trial meets our post-approval commitment to the
EMEA and underscores our determination to move forward as quickly as
possible with the commercial launch of the drug in the European Union.
Ceplene® is an important therapy for AML patients because it
is the only medical therapy ever proven to prevent relapse in this
deadly disease.”
About Ceplene®
Ceplene®
is EpiCept's proprietary product approved in
the European Union for maintenance therapy for adult patients with AML
in first remission. 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. In October 2008
Ceplene®
received full marketing approval in the
European Union for maintenance therapy and prevention of relapse in
adult patients with AML in first remission.
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 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 EpiCeptTM 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 Ceplene® will not be
launched in Europe in the second half of 2009 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 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 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
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 EpiCeptTM
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 EpiCeptTM
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 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
*Azixa is a registered trademark of Myriad Genetics, Inc.