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Vical Incorporated Message Board

  • left2rightdoor left2rightdoor Jan 15, 2013 2:09 PM Flag

    Will Vical's top line data release be pre-announced like Celsion

    Celsion said first, we met the number of events, now we will release results in 2 months. Will Vical do the same two-step dance?

    Celsion Announces Phase III HEAT Study of ThermoDox(R) in Primary Liver Cancer Reaches Target Number of Events for Unblinding
    Company Begins Data Collection, Expects to Report Top Line Data in January 2013; Reiterates Strong Balance Sheet Position
    LAWRENCEVILLE, NJ -- (Marketwire) -- 11/09/12 -- Celsion Corporation (NASDAQ: CLSN), a leading oncology drug development company, today announced that it projects that a minimum of 380 events of progression have been realized in the Company's pivotal, Phase III HEAT Study, a multinational, double-blind, placebo-controlled, pivotal study of ThermoDox® in combination with radiofrequency ablation (RFA) for the treatment of hepatocellular carcinoma (HCC), also known as primary liver cancer. According to protocol, 380 events of progression, subject to confirmation by the Study's independent Data Monitoring Committee (DMC), trigger the data collection process, unblinding and final analysis of the results by the DMC. Progression Free Survival (PFS) is the HEAT Study's primary endpoint. The HEAT Study has been granted Special Protocol Assessment by the FDA. Following DMC review, the Company plans to disclose top line results, an announcement that is expected to occur in January 2013.

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    • Because VJ had to push the timelines back twice, I wouldn't be surprised if he pushed the mid year time estimate well past the actual anticipated target date....just to avoid having to do it again. It would not surprise me if the A-7 threshold is attained a few months earlier than the new projection.JMHO

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