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news.An independent monitoring panel has found no safety concerns in its analysis of Biovest's anticancer vaccine BiovaxID, a conclusion that the company is hoping will support its application for an accelerated approval.
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Biovest International, a majority owned subsidiary of Accentia Biopharmaceuticals, added that the independent safety panel has requested an interim analysis of all primary and secondary endpoints. The company said it believes that BiovaxID's strong safety record will be supportive of its planned application for accelerated conditional approval of BiovaxID.
BiovaxID is an anticancer vaccine that is in phase III trials for the indication of non-Hodgkins lymphoma. BiovaxID is a personalized, patient specific vaccine designed to stimulate the patient's own immune system to recognize and destroy cancerous B-cells that may remain in the body or may arise after the patient has been treated with chemotherapy.
The chairman of the Data Monitoring Committee (DMC), Dr Gerry Messerschmidt, said: “There are no identifiable safety concerns in the current BiovaxID phase III pivotal clinical trial at this time in our data review.”
Applications for accelerated conditional approval of BiovaxID are planned to be submitted to both the FDA and European Medicines Agency (EMEA) by mid-2008. The DMC has agreed to serve as a liaison between the Company and the FDA and the EMEA. If conditionally approved by the target date of mid-June 2008, BiovaxID would be commercially available in early 2009.