EpiCept Provides Update on Clinical and Regulatory Progress with Ceplene(TM) and
EpiCept(TM) NP-1 Cream
TARRYTOWN, N.Y., Jan. 23 -- EpiCept Corporation (Nasdaq and OMX Nordic Exchange:
EPCT) today provided updates on the regulatory and clinical status of
Ceplene(TM) (histamine dihydrochloride) and EpiCept(TM) NP-1 Cream.
(Logo: http://www.newscom.com/cgi-bin/prnh/20020513/NYM112LOGO )
EpiCept announced today that its Marketing Authorization Application (MAA)
seeking marketing approval for Ceplene in the European Union has advanced to the
next important step. The Company has submitted full written responses to the Day
180 List of Outstanding Issues to the Committee for Human Medicinal Products
(CHMP). With this response, EpiCept believes it has now addressed all
outstanding issues related to the MAA.
The next regulatory milestone for Ceplene will be an Oral Explanation (OE)
before all member states of the CHMP reviewing this MAA. The OE will be
scheduled for later this quarter. Following this hearing, a recommendation on
the approvability of Ceplene will be issued by the CHMP, which will be followed
by a final decision by the European Commission.
EpiCept also said today that it expects to unblind and announce the results from
its Phase II "Neuracept" trial for EpiCept NP-1 cream in patients suffering from
diabetic peripheral neuropathy (DPN) in the near future. This study was designed
to collect data on 200 patients; because 231 patients were randomized in this
trial, slightly more time than was previously anticipated is required to compile
and analyze the data.
About Ceplene
Ceplene is EpiCept's registration-stage compound for the treatment of AML.
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.
About EpiCept NP-1
EpiCept NP-1 is a patented topical cream formulation of two FDA- approved drugs,
4% amitriptyline and 2% ketamine, and is intended to provide long-term relief
from the pain of peripheral neuropathies. Peripheral neuropathies are medical
conditions caused by damage to the nerves in the peripheral nervous system. The
peripheral nervous system includes nerves that run from the brain and spinal
cord to the rest of the body. It is estimated that these conditions affect more
than 15 million people in the U.S. and is associated with conditions that injure
peripheral nerves, including herpes zoster, or shingles, diabetes, chemotherapy,
HIV and other diseases.
About EpiCept Corporation
EpiCept is focused on unmet needs in the treatment of pain and cancer. 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 is approaching a decision 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: the risk that Ceplene will not receive regulatory approval or
marketing authorization in the EU or that Ceplene, if approved, will not achieve
significant commercial success, 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 EPC 2407 will not
be successful, the risk that NP-1 or EPC 2407 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; competition; litigation;
risks associated with prior material weaknesses in our internal controls; 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.
SOURCE EpiCept Corporation
-0- 01/22/2008
/CONTACT: Robert W. Cook of EpiCept Corporation, +1-914-606-3500, or
rcook@epicept.com, or Media, Greg Kelley of Feinstein Kean Healthcare,
+1-617-577-8110, or gregory.kelley@fkhealth.com, for EpiCept Corporation, or
Investors, Kim Sutton Golodetz, +1-212-838-3777, or kgolodetz@lhai.com, or Bruce
Voss, +1-310-691-7100, or bvoss@lhai.com, both of Lippert-Heilshorn &
Associates, for EpiCept Corporation/
/Photo: http://www.newscom.com/cgi-bin/prnh/20020513/NYM112LOGO /
/Web site: http://www.epicept.com /
(EPCT)
EpiCept Provides Update on Clinical and Regulatory Progress with Ceplene(TM) and EpiCept(TM) NP-1 Cream
| Source: Immune Pharmaceuticals Inc