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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?


To: dr.praveen who wrote (18613)6/8/2006 10:00:51 PM
From: tnsaf  Respond to of 52153
 
NeoPharm Announces PRECISE Trial Has Reached Criteria for Interim Efficacy Analysis; Independent Data Monitoring Committee to Conduct Interim Efficacy Analysis
6/8/2006 8:40:00 AM EST

BIOWIRE

NeoPharm (Nasdaq:NEOL) today announced that it has received notification that the Company's cintredekin besudotox (IL13-PE38QQR) Pivotal Phase III PRECISE trial for the treatment of Glioblastoma Multiforme (GBM), the most aggressive form of brain cancer, has reached the criterion for the interim efficacy statistical analysis (160 deaths). As a result, the PRECISE trial's independent Data Monitoring Committee (DMC) will assess the study data to date, conduct an interim efficacy analysis, and thereafter provide its recommendation to the Company. The Company currently expects to receive the DMC's recommendation within 10-14 business days.

In accordance with the Study protocol, an interim efficacy analysis will be conducted by the DMC to evaluate potential superiority of long-term patient survival of cintredekin besudotox versus Gliadel(R) Wafer. The DMC will inform the company that it has reached the pre-specified statistical endpoint or continue to the final efficacy analysis at the 215th death, expected to occur in late 2006 or early 2007.