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FDA approves secondary endpoint in Biovest's phase 3 trial of BiovaxID in non-Hodgkin's lymphoma
By Lisa Kerner
Erie, Pa., May 16 - The Food and Drug Administration has accepted Biovest International, Inc.'s proposal to use molecular remissions data as a new secondary endpoint in its ongoing pivotal phase 3 trial evaluating BiovaxID for treatment of follicular non-Hodgkin's lymphoma.
Biovest previously reported positive phase 2 results for BiovaxID in which 95% of BiovaxID- treated patients are still alive more than nine years after treatment and 70% of evaluable patients showed no evidence of tumor cells when measured using remissions data, according to a news release.
The company had requested the FDA review data on molecular remissions, combined with physical examination and CT scan evidence of gross tumor remission as part of a revised secondary endpoint for its ongoing trial and as part of annual Data Safety Monitoring Board reviews of its clinical trial.
"The FDA's encouragement to move forward with this revised end point and data analysis could allow Biovest to shorten the time it takes to show a difference between treatment and control arms in the ongoing pivotal phase 3 study," chairman and chief executive officer Steve Arikian said in the release.
"This may allow us to apply for approval of BiovaxID significantly earlier than might otherwise be possible."
Located in Worcester, Mass., Biovest, a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc., develops, manufactures and markets patented cell culture systems.
Accentia, located in Tampa, Fla., develops and commercializes late-stage clinical products in the therapeutic areas of respiratory disease and oncology.
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