Patient Enrollment Completed in Phase IIb Trial of EpiCept(TM) NP-1 in Diabetic
Peripheral Neuropathy
Top-line data expected in early 2008
TARRYTOWN, N.Y., Dec. 3 /PRNewswire / -- EpiCept Corporation (Nasdaq and OMX
Nordic Exchange: EPCT) today announced that it has completed patient enrollment
in the Phase IIb "Neuracept" trial for EpiCept(TM) NP-1 cream. 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.
(Logo: http://www.newscom.com/cgi-bin/prnh/20020513/NYM112LOGO )
This Phase IIb trial compares the active ingredients in NP-1 against placebo in
patients suffering from diabetic peripheral neuropathy (DPN), the most common
form of neuropathic pain. Only two medications are currently available in the
United States for the treatment of DPN. The four-week, 200-patient trial is
intended to confirm and expand upon earlier work that provided a preliminary
efficacy signal in this type of neuropathic pain. The primary endpoint for the
Phase IIb trial is the difference between active and placebo changes in pain
intensity from baseline compared to the average over the last seven days of
treatment.
"We are pleased to have reached another key clinical milestone that we
established for 2007, and to have advanced another one of our product
candidates," stated Jack Talley, President and Chief Executive Officer of
EpiCept. "We believe NP-1 holds the largest market potential of the pain
candidates in our portfolio. Treatment of neuropathic pain is a billion dollar
opportunity. We believe that NP-1 has the potential to become a new and
efficacious topical treatment without the inherent systemic side effects of
alternative treatments for the 15 million Americans who suffer from peripheral
neuropathies. We expect to report top-line results from this trial in early
2008."
In addition to the NP-1 trial in DPN, there are two other clinical trials for
NP-1 currently underway.
-- A Phase III trial in chemotherapy-induced peripheral neuropathy (CPN)
is being conducted by the National Cancer Institute (NCI)-funded
Community Clinical Oncology Program. The double-blind, randomized
placebo-controlled study includes approximately 400 patients suffering
from painful CPN for at least 28 days following the conclusion of
chemotherapy. The primary endpoint of the 12-week trial is change in
average daily pain intensity scores from baseline to the endpoint.
This trial is currently enrolling patients.
-- A Phase IIb trial is underway in peripheral herpetic neuropathy. This
500-patient, placebo- and active-controlled trial will compare the
efficacy and safety of NP-1 vs. gabapentin and placebo. The primary
endpoint for this trial is the change in pain intensity over the four-
week duration of the trial. Preliminary results are expected early in
the second quarter of 2008.
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 our NP-1 clinical trials will not be successful, that
NP-1 will not receive regulatory approval or achieve significant commercial
success, 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 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 EPC 2407 will not be successful,
that 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 EpiCept
will not obtain approval to market any of its product candidates, the risks
associated with 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 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- 12/03/2007
/CONTACT: EpiCept Corporation, Robert W. Cook, +1-914-606-3500,
rcook@epicept.com; Media, Greg Kelley, +1-617-577-8110, Feinstein Kean
Healthcare, gregory.kelley@fkhealth.com; or Investors, Kim Sutton Golodetz,
+1-212-838-3777, kgolodetz@lhai.com, or Bruce Voss, +1-310-691-7100,
bvoss@lhai.com, both of Lippert/Heilshorn & Associates /
/Photo: Newscom: http://www.newscom.com/cgi-bin/prnh/20020513/NYM112LOGO/
/Web site: http://www.epicept.com /
(EPCT)
Patient Enrollment Completed in Phase IIb Trial of EpiCept(TM) NP-1 in Diabetic Peripheral Neuropathy
| Quelle: Immune Pharmaceuticals Inc