EpiCept shares plummet; Leukemia drug Ceplene not approved by European committee

Date : 02/28/2008 @ 11:29AM
Source : TFN
Stock : Epicept Corporation (EPCT)
Quote : 0.67  0.03 (4.69%) @ 8:00PM
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EpiCept shares plummet; Leukemia drug Ceplene not approved by European committee

        BOSTON (Thomson Financial) - Shares of EpiCept Corp. plummeted Thursday
after the Tarrytown, N.Y.-based pharmaceutical company said a "slight" majority
vote by members of the European Committee for Medicinal Products for Human Use
(CHMP) did not favor recommending the company's cancer drug, Ceplene, for the
maintenance of remission and prevention of relapse in patients with Acute
Myeloid Leukemia (AML).
    The stock tumbled 26% to $1.10 on volume of 363,000 shares, nearly three
times the issue's 30-day average volume of 125,000 shares. 
    The company recently presented an oral explanation to the CHMP and the
scientific committee of the European Medicines Agency (EMEA) and while the
majority of the CHMP considered the data presented supportive of the product's
efficacy and safety in AML, the committee said the data should be confirmed by
further clinical data from an additional, replicate study. 
    "We are disappointed with the results," EpiCept said. "As we head towards a
final vote on the marketing authorization application next month, we are
assessing potential options to gain approval and, if the final opinion is
negative, whether that decision should be appealed."
Greg Saulnier
gs/vj

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