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news.Biovest International, a subsidiary of Accentia Biopharmaceuticals, has announced its regulatory strategy for the fast tracked Phase III clinical trial of its anticancer vaccine, BiovaxID for the treatment of non-Hodgkin's lymphoma.
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Subject to the completion of the anticipated analysis of the unblinded trial data, the company plans to seek accelerated conditional approval for BiovaxID in the US, Europe and Switzerland. The company anticipates scheduling meetings with the Food and Drug Administration and European Agency for the Evaluation of Medicinal Products (EMEA) to review its revised strategy for early approval of BiovaxID.
Dr Angelos Stergiou, Biovest’s executive director of medical affairs and clinical research, said: “BiovaxID is a promising personalized therapeutic vaccine for follicular lymphoma. With the previously-announced Phase II efficacy follow-up data of more than 9 years with a survival rate of 95% and the current outstanding safety profile of the Phase II and Phase III trials, along with our large sample size of over 200 subjects to date, we are encouraged by BiovaxID’s risk-benefit ratio for treatment of follicular non-hodgkin’s lymphoma.”