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17 JUL 2008: Biovest International, Inc. (OTCBB:BVTI), a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI), today announced clinically and statistically significant unblinded data from its randomized controlled pivotal Phase 3 Fast-Tracked clinical trial of BiovaxID® (personalized anti-idiotype vaccine) for the treatment of indolent follicular non-Hodgkin’s lymphoma (NHL), an often fatal blood cancer. Biovest's BiovaxID prolonged disease-free survival in patients with follicular lymphoma, meeting the primary endpoint of a pivotal Phase III trial. In the randomized, double-blinded placebo-controlled trial, 629 follicular lymphoma patients in first remission received either injection with BiovaxID plus granulocyte macrophage colony-stimulating factor (GM-CSF), or injection with keyhole limpet hemocyanin (KLH), which acted as the placebo, plus GM-CSF. The median disease-free survival in patients who received BiovaxID was 33.8 months, an increase of one year compared to patients in the control arm, whose disease-free survival was 21.2 months. Three years after injection, the rate of disease-free survival was approximately 100% higher in the BiovaxID arm. Both of these results reached statistical significance. BiovaxID is a personalized therapeutic vaccine that combines a tumor-specific idiotype protein, derived from the patient's lymph node biopsy tissue, and KLH, a protein carrier. Biovest, a majority-owned subsidiary of Accentia, is developing the drug, and now intends to seek accelerated and/or conditional approvals in the US and EU for follicular lymphoma. Follicular lymphoma is one of the most common types of non-Hodgkin's lymphoma (NHL), with a forecast incidence of approximately 30,000 in the seven major pharmaceutical markets in 2008. Current treatment options for the disease are rarely curative, and nearly all patients eventually suffer relapse following first-line therapy. Median overall survival is typically between eight and 10 years. Related Research Cancer Vaccines: Aim and Shoot Cancer Vaccines: Drug Pipeline Update 2008 Triple Analysis: Apoptosis Agents, Antibodies and Vaccines in Oncology Triple Analysis: Protein Kinase Inhibitors, Antibodies and Vaccines in Oncology Triple Analysis: Melanoma Therapeutics, Antibodies and Vaccines in Oncology |
