EpiCept (EPCT) Responds to Negative Opinion From EMEA for Ceplene
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EpiCept Corporation (Nasdaq: EPCT) announced that the European Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), has issued, as expected following the trend vote announced last month, a negative opinion regarding the marketing authorization application (MAA) for Ceplene® (histamine dihydrochloride) for the remission maintenance and prevention of relapse of patients with Acute Myeloid Leukemia (AML) in first remission. Ceplene is designated as an orphan medicinal product in the European Union with respect to this indication.
In reaching this opinion, the CHMP stated that further data are required to support the results from EpiCept’s Phase III clinical study of Ceplene. The CHMP indicated that data from the single pivotal AML trial was not adequately statistically compelling.
In accordance with the rules governing the European Centralized procedure, EpiCept has already requested a re-examination of this opinion through the appeal procedure. No formal decision will be taken by the European Commission, as the European licensing authority, until the appeal procedure has been completed. EpiCept intends to submit a document setting out the “Detailed Grounds for Re-Examination” within 60 days of receipt of the negative opinion and expects its appeal proceeding to take place in the third quarter of this year.
(NOTE - Shares Trade Under $1)[SM]
In reaching this opinion, the CHMP stated that further data are required to support the results from EpiCept’s Phase III clinical study of Ceplene. The CHMP indicated that data from the single pivotal AML trial was not adequately statistically compelling.
In accordance with the rules governing the European Centralized procedure, EpiCept has already requested a re-examination of this opinion through the appeal procedure. No formal decision will be taken by the European Commission, as the European licensing authority, until the appeal procedure has been completed. EpiCept intends to submit a document setting out the “Detailed Grounds for Re-Examination” within 60 days of receipt of the negative opinion and expects its appeal proceeding to take place in the third quarter of this year.
(NOTE - Shares Trade Under $1)[SM]
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