EpiCept Announces Successful Completion of Enrollment for Phase I Trial of
EPC2407
Follow up Combination Therapy Trial planned for 2008
TARRYTOWN, N.Y., Oct. 8 -- EpiCept Corporation (Nasdaq and OMX Nordic
Exchange: EPCT) today announced that it has completed its Phase I clinical
trial for EPC2407. The trial has met all of its objectives. EPC2407 is
EpiCept's novel small molecule vascular disruption agent (VDA) and apoptosis
inducer for the treatment of patients with advanced solid tumors and lymphomas.
(Logo: http://www.newscom.com/cgi-bin/prnh/20020513/NYM112LOGO )
EpiCept successfully identified the maximum tolerated dose of EPC2407 in
the Phase I study. The maximum tolerated dose was well below the dose which
produced the expected toxicity based on preclinical studies at higher doses.
EPC2407 was administered as a single agent in increasing doses to small cohorts
of patients with advanced solid tumors. A total of seventeen patients were
enrolled in the study. The drug was tested in a variety of cancer types
including melanoma, prostate, lung, breast, colon, and pancreatic cancers. The
study, which was initiated in December 2006, was conducted at three cancer
centers in the U.S.
"We are pleased that this milestone has been reached," stated Jack Talley,
President and Chief Executive Officer. "We are now in the process of meeting
with our advisors to move forward with a Phase Ib combination trial for the
drug with other chemotherapeutic agents. Preclinical data in mouse xenograft
models indicate there is either additive or synergistic activity when EPC2407
is used in combination with other cancer therapeutic agents including
Cisplatin, Sutent(R)* and Avastin(R)*. We anticipate being able to initiate
this combination trial in early 2008."
In addition to determining the maximum tolerated dosage of the EPC2407, the
primary objective of the study was to determine the pharmacokinetic profile of
the drug. Results from the study will also help characterize the
pharmacodynamic effects on tumor blood flow and potentially identify early
signs of objective anti-tumor response as measured by CT scans, MRI or PET, in
advanced cancer patients with well vascularized solid tumors.
Mr. Talley continued, "Our advancement of EPC2407 and the regulatory
progress we announced earlier this month on Ceplene(TM), demonstrates the
opportunities inherent in our pursuit of both early- and late-stage cancer
programs, and, when combined with our pipeline of pain candidates, illustrates
the long-term potential offered by our company."
About EPC2407
EPC2407 was discovered through EpiCept's Anti-cancer Screening Apoptosis
Program (ASAP), a proprietary technology used to rapidly test and generate
product candidates for cancer. EPC2407 has shown promising vascular targeting
activity with nanomolar potencies of anti-tumor activity in pre-clinical in
vitro and in vivo studies. The molecule 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 EPC2407 inhibits growth of established tumors of a number of
different cancer types more effectively than the other VDAs tested and was
synergistic when used in combination with anticancer agents, such as Cisplatin.
EPC2407 is one of two VDA compounds currently in clinical trials discovered
through EpiCept's ASAP technology. The second compound, Azixa(TM), is part of
the EP90745 series of apoptosis inducers, which was licensed by EpiCept to
Myriad Genetics, Inc. as part of an exclusive, worldwide development and
commercialization agreement.
About EpiCept's ASAP Technology
Cancer cells often exhibit unchecked growth caused by the disabling or
absence of the natural process of programmed cell death, which is called
apoptosis. Apoptosis is normally triggered to destroy a cell from within when
it outlives its purpose or it is seriously damaged. One of the most promising
approaches in the fight against cancer is to selectively induce apoptosis in
cancer cells, thereby checking, and perhaps reversing, the improper cell
growth.
EpiCept's proprietary apoptosis screening technology can efficiently
identify new cancer drug candidates and molecular targets that selectively
induce apoptosis in cancer cells through the use of chemical genetics and its
proprietary live cell high-throughput caspase-3 screening technology. Chemical
genetics is a research approach investigating the effect of small molecule drug
candidates on the cellular activity of a protein, enabling researchers to
determine the protein's function. Using this approach with its proprietary
caspase-3 screening technology, EpiCept researchers can focus their
investigation on the cellular activity of small molecule drug candidates and
their relationship to apoptosis.
This combination of chemical genetics and caspase-3 screening technology
allows EpiCept's researchers to discover and rapidly test the effect of small
molecules on pathways and molecular targets crucial to apoptosis, and gain
insights into their potential as new anticancer agents. This screening
technology is particularly versatile and can be adapted for almost any cell
type that can be cultured, as well as measure caspase activation inside
multiple cell types (e.g., cancer cells, immune cells, or cell lines from
different organ systems or genetically engineered cells). This allows
researchers to find potential drug candidates that are selective for specific
cancer types, which may help identify candidates that provide increased
therapeutic benefit and reduced toxicity.
EpiCept has identified several families of compounds with potentially novel
mechanisms that induce apoptosis in cancer cells. Several compounds from
within these families have progressed to lead drug candidate status with proven
pre-clinical efficacies in tumor models and identified molecular targets.
About EpiCept Corporation
EpiCept is focused on unmet needs in the treatment of pain and cancer.
EpiCept has a staged portfolio of pharmaceutical product candidates with
several pain therapies in late-stage clinical trials, and a lead oncology
compound (for acute myeloid leukemia, or AML) with demonstrated efficacy in a
Phase III trial; a marketing authorization application for this compound has
been submitted in Europe. EpiCept is based in Tarrytown, N.Y., and its
research and development team in San Diego is pursuing a drug discovery program
focused on novel approaches to apoptosis.
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 clinical trials for EPC2407 will
not be successful, that EPC2407 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 NP-1
will not be successful, that NP-1 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 reliance on additional outside
financing to meet its capital requirements, 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.; Sutent is a
registered trademark of Pfizer Inc.; Avastin is a registered trademark of
Genentech Inc.
SOURCE EpiCept Corporation
-0- 10/08/2007
/CONTACT: Robert W. Cook, EpiCept Corporation, +1-914-606-3500,
rcook@epicept.com; Media, Greg Kelley, Feinstein Kean Healthcare,
+1-617-577-8110, 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, all for EpiCept /
/Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20020513/NYM112LOGO
PRN Photo Desk, photodesk@prnewswire.com/
/Web site: http://www.epicept.com/
(EPCT)
EpiCept Announces Successful Completion of Enrollment for Phase I Trial of EPC2407
| Source: Immune Pharmaceuticals Inc