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EpiCept Corp. (EPCT) Receives Positive Opinion for Adult Leukemia Drug Candidate

EpiCept Corp. (Nasdaq: EPCT) develops drug candidates for the treatment of cancer and pain. The company’s Ceplene compound was designed to combat acute myeloid leukemia (AML), the most common type of leukemia in adults, by protecting lymphocytes that cause the destruction of residual leukemic cells. According to the company, there are roughly 40,000 AML patients in the European Union, with 16,000 new cases occurring each year.

The company today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has issued a second opinion regarding the marketing authorization for Ceplene following a request by EpiCept to re-evaluate the committee’s initial negative report in March 2008.

After a re-examination, CHMP released a positive opinion for the remission maintenance and prevention of a relapse in adult patients with AML. In the first remission, Ceplene is administered with low-dose interleukin-2 (IL-2).

“We are thrilled with the positive opinion reached by the CHMP and are pleased by the overwhelming support for Ceplene we received from key opinion leaders in hematology across Europe during this successful re-examination effort,” Jack Talley, president and CEO of EpiCept stated in the press release. “Ceplene, in conjunction with IL-2, is the first therapy shown to significantly prolong leukemia-free survival and prevent relapse in AML patients in first remission.”

Securing designation as an orphan medicinal product allows EpiCept to exclusively market Ceplene in the EU for up to 10 years, as granted by CHMP. Per the agreement, EpiCept has marketing authorization under Exceptional Circumstances, in which it must perform two post-approval clinical studies.

One study is expected to assess biomarkers in AML patients in first remission; the second will assess the effect of Ceplene/IL-2 on the development of minimal residual disease. CHMP will forward its opinion to the European Commission for issuing a marketing authorization for clinical usage in Iceland, Liechtenstein and Norway.

“We are highly optimistic about the commercial prospects for Ceplene and we intend to pursue its commercial introduction as expeditiously as possible,” Talley stated. “We are evaluating all of our strategic options for the marketing of Ceplene, and will continue to work towards realizing the drug’s potential to fulfill an important unmet medical need for AML patients in Europe.”

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