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EpiCept Provides Update on Clinical and Regulatory Progress with Ceplene(TM) and EpiCept(TM) NP-1 Cream
Date:1/22/2008

TARRYTOWN, N.Y., Jan. 22 /PRNewswire-FirstCall/ -- EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) today provided updates on the regulatory and clinical status of Ceplene(TM) (histamine dihydrochloride) and EpiCept(TM) NP-1 Cream.

(Logo: http://www.newscom.com/cgi-bin/prnh/20020513/NYM112LOGO )

EpiCept announced today that its Marketing Authorization Application (MAA) seeking marketing approval for Ceplene in the European Union has advanced to the next important step. The Company has submitted full written responses to the Day 180 List of Outstanding Issues to the Committee for Human Medicinal Products (CHMP). With this response, EpiCept believes it has now addressed all outstanding issues related to the MAA.

The next regulatory milestone for Ceplene will be an Oral Explanation (OE) before all member states of the CHMP reviewing this MAA. The OE will be scheduled for later this quarter. Following this hearing, a recommendation on the approvability of Ceplene will be issued by the CHMP, which will be followed by a final decision by the European Commission.

EpiCept also said today that it expects to unblind and announce the results from its Phase II "Neuracept" trial for EpiCept NP-1 cream in patients suffering from diabetic peripheral neuropathy (DPN) in the near future. This study was designed to collect data on 200 patients; because 231 patients were randomized in this trial, slightly more time than was previously anticipated is required to compile and analyze the data.

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 formation of oxygen radicals from phagocytes, inhibiting NADPH oxidase and protecting IL-2-activat
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