Regulatory News:
EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) has released
new long-term data showing that the use of Ceplene®
when administered in conjunction with low-dose interleukin-2 (IL-2)
provides durable protection from leukemia relapse in patients with Acute
Myeloid Leukemia (AML), based on a minimum of six years of follow-up.
These data will be presented on June 6, 2009 at the European Hematology
Association’s (EHA) 14th Congress in Berlin, Germany.
The presentation entitled "Six-Year Outcomes Update from a Randomized
Phase 3 Trial in AML: Durable Effect of Remission Maintenance
Immunotheraphy with Histamine Dihydrochloride and low-dose IL-2” was
authored by Dr. Mats Brune, MD and co-workers.
Researchers analyzed follow-up data from patients enrolled in the Phase
III pivotal trial of Ceplene®. The primary endpoint
assesses the durability of the benefit of Ceplene®
with IL-2 in achieving leukemia-free-survival (LFS), after a minimum of
six years, in patients who have achieved first complete remission (CR1)
and among the overall patient group. The study found that the Ceplene®/IL-2
treatment group continued to show statistically significant differences
in LFS in the overall treatment population (p=0.011) and among the CR1
group (p=0.015).
"These data provide further demonstration of the positive and prolonged
clinical benefits Ceplene® can provide AML patients in
preventing relapse of this deadly disease,” remarked Jack Talley,
President and CEO of EpiCept. "These findings also represent the latest
in a number of significant milestones for Ceplene®, as
we just announced that the drug is now available to patients in major
markets throughout the world through our named patient program agreement
with IDIS. We continue to be keenly focused on further expanding the
extraordinary impact that Ceplene® can have on AML
patients through our regulatory advancement of the drug in North
America.”
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 risk that we will not have
sufficient authorized shares of stock to raise equity capital, 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 or the OMX Nordic Exchange 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.