Regulatory News:
EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) today
announced that the United States Adopted Names Council (USAN) has
approved "crinobulin” as the generic name for EPC2407, the company’s
novel, small molecule vascular disruption agent (VDA) and apoptosis
inducer for the treatment of patients with advanced solid tumors and
lymphomas.
Crinobulin has shown promising vascular targeting activity with potent
anti-tumor activity in both pre-clinical and early clinical studies. In
pre-clinical 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.
Murine models of human tumor xenografts demonstrated that crinobulin
inhibits growth of established tumors of a number of different cancer
types.
In terms of clinical activity, the preliminary results of 33 patients
treated in a Phase I dose escalating monotherapy study provided visible
radiographic evidence of vascular disruptive activity. A wide variety of
advanced tumor types, including hepatic, pancreatic, non-small cell
lung, colon, prostate and gastrointestinal cancers, as well as
metastatic melanoma, and parotid carcinoma - have been treated with
crinobulin. Crinobulin, administered over a four-hour intravenous
infusion for a cycle of three days, caused no thrombocytopenia,
leucopenia, or neutropenia at any dose studied. In addition, it did not
cause renal or hepatic dysfunction. Crinobulin has been well tolerated
and administered for up to eight cycles with stable disease for six
month’s duration.
EpiCept is currently evaluating the pharmacokinetic and pharmacodynamic
effects of crinobulin with different dosage schedules from the Phase I
study and expects to initiate a Phase Ib combination trial with
crinobulin in combination with other chemotherapeutic agents in the
second half of 2009.
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 Ceplene®, a cytokine immunomodulator that recently
received marketing authorization in Europe for the remission maintenance
of AML patients, and several pain therapies in clinical development. Two
oncology drug candidates currently in clinical development that were
discovered using in-house 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 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 our announced public offering
will not close, 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 U.S. or Canada, the risk that Ceplene®
will not be launched in Europe in the first 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 will not be successful, the risk that we
will not be able to maintain its final regulatory approval or marketing
authorization, 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 NP-1 or
crinobulin will not be successful, the risk that 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 NP-1 on attractive terms or a timely
basis 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 other
product candidates, the risks associated with our 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 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 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