The interim blinded data covers 122 patients who have received either BiovaxID or control vaccine. The trial showed that approximately 40% of the evaluable patients in the study remained disease-free from 40 months to almost 70 months.
BiovaxID is an anticancer vaccine undergoing testing in a fast-tracked pivotal phase III clinical trial for a target indication of Non-Hodgkin’s Lymphoma. BiovaxID is a personalized, patient-specific vaccine designed to stimulate the patient’s own immune system to recognize and destroy residual cancerous B-cells that remain after the patient has undergone chemotherapy.
Unlike many other approaches to treating non-Hodgkin’s lymphoma, BiovaxID is designed to target only cancerous B-cells. The BiovaxID phase III clinical trial is being conducted at 14 US oncology centers and eight centers in Russia.
Applications for accelerated conditional approval of BiovaxID are planned to be submitted to both the FDA and EMEA by mid-2008. If conditionally approved, BiovaxID could become commercially available in early 2009.