ENGLEWOOD CLIFFS, N.J., Nov. 1 /PRNewswire-FirstCall/ -- EpiCept
Corporation (Nasdaq and OMX Stockholm: EPCT) today announced successful
validation of the Marketing Authorization Application (MAA) for Ceplene(TM)
(histamine dihydrochloride) by the European Medicines Agency for the
Evaluation of Medicinal Products (EMEA). Ceplene is EpiCept's lead oncology
product candidate that administered in conjunction with low dose
interleukin-2 (IL-2) will be indicated for use in the maintenance of first
remission in patients with Acute Myeloid Leukemia (AML). This positive
outcome of validation signifies that the EU centralized evaluation
procedure for this MAA will start at the published date of October 25,
2006. Validation of the application means that the EMEA has reviewed the
application for completeness, selected the reviewers for the application
and set a timetable for the review of the product candidate.
(Logo: http://www.newscom.com/cgi-bin/prnh/20020513/NYM112LOGO )
"We are pleased to have executed on another important milestone for
this product candidate and for our company overall," remarked Jack Talley,
President and Chief Executive Officer. "With the validation of our MAA
achieved, we anticipate that we will be able to obtain further insights
into the approvability of the compound during the first half of 2007."
The MAA submission for Ceplene will be reviewed under the EU
centralized procedure, and if approved, would provide a marketing
authorization valid in all EU member states, together with Iceland,
Liechtenstein and Norway. The European Commission has previously granted
orphan drug status to Ceplene for use in the treatment of AML.
About Acute Myeloid Leukemia (AML)
AML is the most common form of acute leukemia in adults. There are
approximately 47,000 AML patients in the EU, with 14,000 new cases
occurring each year. Prospects for long-term survival are poor for the
majority of AML patients. Once diagnosed with AML, patients are typically
treated with chemotherapy. Although approximately 75 percent of patients
achieve a complete remission after such treatment, the leukemia frequently
recurs ("relapse"), usually within 1-2 years. Because of the high rate of
relapse among patients with AML, only approximately 20% will survive
long-term. There are currently no approved remission maintenance therapies
for AML patients.
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 oxygen radical formation and release
of phagocytes by inhibiting NADPH oxidase, thus protecting IL-2-activated
NK-cells and T-cells from oxygen radical-induced inhibition and apoptosis.
About EpiCept Corporation
EpiCept is an emerging specialty pharmaceutical company focused on
unmet needs in the treatment of pain and cancer. The Company has a staged
portfolio of product candidates with several pain therapies in late-stage
clinical trials, and a lead oncology compound (for acute myeloid leukemia,
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 New Jersey, and the Company's 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 contains certain forward-looking statements that
involve risks and uncertainties that could cause actual results to be
materially different from historical results or from any future results
expressed or implied by such forward-looking statements. Such
forward-looking statements include statements regarding the regulatory
status of Ceplene, the efficacy, safety, and intended utilization of the
Company's other product candidates, the conduct and results of future
clinical trials, the sufficiency of the Company's existing capital
resources, plans regarding regulatory filings, future research and clinical
trials and plans regarding partnering activities. Factors that may cause
actual results to differ materially include the risk that Ceplene will not
receive regulatory approval or marketing authorization in the EU, the risk
that 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 the Company will not obtain
approval to market its product candidates, the risks associated with
reliance on outside financing to meet capital requirements, and the risks
associated with reliance on collaborative partners for further clinical
trials, development and commercialization of product candidates. You are
urged to consider statements that include the words "may," "will," "would,"
"could," "should," "believes," "estimates," "projects," "potential,"
"expects," "plans," "anticipates," "intends," "continues," "forecast,"
"designed," "goal," or the negative of those words or other comparable
words to be uncertain and forward-looking. These factors and others are
more fully discussed in the Company's periodic reports and other filings
with the SEC.
EPCT-GEN
SOURCE EpiCept Corporation
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