Regulatory News:
EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) today
announced that it will present data from its Phase Ia trial of
crinobulin at the 45th Annual Meeting of the American Society
of Clinical Oncology (ASCO), taking place May 29 to June 2, 2009 in
Orlando, Florida. Crinobulin is EpiCept’s novel small molecule vascular
disruption agent (VDA) and apoptosis inducer for the treatment of
patients with advanced solid tumors and lymphomas.
Presentation details are as follows:
Abstract #3569 - General Poster Session, Developmental Therapeutics:
Molecular Therapeutics, Saturday, May 30, 2009, 8:00am-12:00pm EDT,
Level 2, West Hall C
Title: "Pharmacokinetic and pharmacodynamic results of a 4-hr IV
administration phase I study with EPC2407, a novel vascular disrupting
agent.”
The authors of the poster evaluated the pharmacokinetic and
pharmacodynamic effects of crinobulin with different dosing schedules.
Prolonged infusion of crinobulin to extend exposure of tumor vasculature
was designed with administration of the compound over four hours for
three consecutive days of a 21-day cycle. Crinobulin demonstrated the
infusion-associated toxicities characteristic of the VDA drug class but
without sustained or cumulative toxicity. Increasing the infusion
duration from 1 hour to 4 hours permitted an approximate 50% increase in
the amount of drug that could be tolerated. Furthermore, this
monotherapy trial in advanced resistant patients showed encouraging
results in selected patients with hepatocellular carcinoma. Early MRI
results also documented a vascular disruptive effect in these patients
as evidenced by decreases in tumor permeability and tumor perfusion.
Jack Talley, President and CEO of EpiCept, commented, "The results of
this study further expands the body of clinical data showing the
clinical promise for crinobulin. We are encouraged by these results and
intend to initiate a Phase 1b combination trial for the compound with
other chemotherapeutic agents in the second half of this year.”
About Crinobulin
Crinobulin has demonstrated potent anti-tumor activity in both
preclinical and early clinical studies. In preclinical in vitro
and in vivo studies, crinobulin has been shown to induce tumor
cell apoptosis and selectively inhibit growth of proliferating cell
lines, including multi-drug resistant cell lines. In April 2008 EpiCept
announced positive clinical data from a Phase I study of crinobulin in
patients with solid tumors.
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 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 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 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.