EpiCept to Sponsor AML Symposium at European Hematology Association Congress
Eighteen EU Hematologists Offer Key Opinion Leader Support for Ceplene Approval
TARRYTOWN, N.Y.--(BUSINESS WIRE)--June 11, 2008--Regulatory News:
EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT)
announced that it will sponsor a symposium at the European Hematology
Association's (EHA) 13th Congress taking place June 12 to 15, 2008 in
Copenhagen, Denmark. The symposium, entitled "Recent advances in
induction and post remission in Acute Myeloid Leukemia (AML)," will be
held on June 12, 2008 from 10:00 a.m. - 12:45 p.m. local time at the
Bella Center, Center Boulevard 5. The Symposium is being co-Chaired by
leading AML experts, Dr. Alan Burnett from Cardiff, Wales and Dr.
Jacob M. Rowe from Haifa, Israel.
Maintenance of remission in AML remains one of the most
significant challenges facing practicing hematologists today.
Induction therapies often result in achievement of complete remission,
however, given the high rate of relapse and the dismal prognosis of
AML patients thereafter, the need for therapies that extend the
duration of remission and prevent relapse is critical. This symposium
will highlight recent progress made in treating AML, focusing on the
current understanding of immune surveillance and discussing the role
of immunotherapy for remission maintenance for AML patients.
Acute Myeloid Leukemia (AML) is the most common type of leukemia
in adults. There are approximately 40,000 AML patients in the European
Union, with 16,000 new cases occurring each year. Once diagnosed with
AML, patients are typically treated with induction chemotherapy and
consolidation therapy, with the majority achieving complete remission.
However, about 75-80% of patients who achieve first remission will
relapse, with the median time in remission before relapse being only
12 months with current treatments. Less than 5% of relapsed patients
survive long term.
EpiCept is pursuing approval in Europe for Ceplene(R) (histamine
dihydrochloride), its product candidate for the remission maintenance
and prevention of relapse in patients with Acute Myeloid Leukemia
(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.
EpiCept is currently pursuing a re-examination of its Marketing
Authorization Application (MAA) for Ceplene before the Committee for
Medicinal Products for Human Use (CHMP) having received a negative
opinion in March 2008. The Company anticipates that appeal proceedings
in regards to this re-examination request will take place in the third
quarter of 2008. As part of this ongoing effort, EpiCept has been
recruiting key opinion leaders across Europe to support a positive
outcome in the re-examination process. To date, the Company has
received the support of 18 key opinion leaders representing eight
countries in Europe, all of whom have endorsed in writing that Ceplene
merits approval and their use in treating AML, based on the current
data.
Jack Talley, President and CEO of EpiCept commented, "We are
grateful to the key opinion leaders who have generously offered their
support for the Ceplene application to be approved for the treatment
of AML patients who have a poor prognosis in the absence of Ceplene.
We intend to continue to pursue additional key opinion leaders for
their support. This effort is an integral part of our re-examination
strategy to be presented to the CHMP."
About EpiCept Corporation
EpiCept is focused on unmet needs in the treatment of cancer and
pain. 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
recently received a negative opinion and is being re-examined 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: our appeal of the
negative opinion regarding the MAA for Ceplene(R) will not be
successful and that Ceplene(R) will not receive regulatory approval or
marketing authorization in the EU, the risk that Ceplene(R) if
approved, will not achieve significant commercial success, the risks
associated with the adequacy of our existing cash resources and 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 our ability to continue to meet our obligations under
our existing debt agreements or that we may default on our loans or
that our lenders may declare the Company in default or that our
secured lender would seek to sell our assets, the risk that the
Company's securities may be delisted by The Nasdaq Capital Market and
that any appeal of the delisting determination may not be successful,
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 NP-1 or EPC2407 will not be successful, the risk
that NP-1 or EPC2407 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 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 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.
CONTACT: EpiCept Corporation:
Robert W. Cook, 914-606-3500
rcook@epicept.com
or
Media:
Feinstein Kean Healthcare
Greg Kelley, 617-577-8110
gregory.kelley@fkhealth.com
or
Investors:
Lippert/Heilshorn & Associates
Kim Sutton Golodetz, 212-838-3777
kgolodetz@lhai.com
or
Bruce Voss, 310-691-7100
bvoss@lhai.com
EpiCept to Sponsor AML Symposium at European Hematology Association Congress
| Source: Immune Pharmaceuticals Inc