Women's Health Weekly
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Ovarian Cancer
Pivotal Trial Completed, Primary Analysis Underway
October 4th, 2001
AltaRex Corp. (AXO.TO) announced that it has reached a major milestone in its OvaRex clinical development program - the completion for primary analysis of its designated pivotal 345-patient OvaRex trial. Primary results from the trial will form the foundation of the Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for marketing approval of OvaRex monoclonal antibody (MAb). Submission of the BLA is expected by year end 2001 or early in 2002, assuming the timely scale-up of cell culture manufacturing to establish product comparability. With the patient treatment now complete for this lead trial, an Endpoint...
Source: Women's Health Weekly (2001-10-04)
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