Positive, Clinically Significant Phase III Results for Personalized Anti-Cancer Vaccine, BiovaxID®, Presented at ASCO Plenary Session

Business Wire, May 31, 2009

• First lymphoma vaccine to demonstrate disease-free survival benefit
• Compassionate-use program to soon launch in Europe

TAMPA, Fla. -- Biovest International, Inc. (Other OTC: BVTI), a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (Other OTC: ABPIQ) today announced that an eight year pivotal, randomized, multi-center, double-blind, controlled Phase III clinical study has shown that BiovaxID® (personalized therapeutic anti-cancer vaccine) significantly prolonged disease-free survival in follicular non-Hodgkin’s lymphoma. The study, which is being featured at today’s American Society of Clinical Oncology (ASCO) Annual Meeting Plenary Session, found that patients who received BiovaxID experienced a median disease-free survival of 44.2 months compared to 30.6 months for those who received a control vaccine – an increase of 47 percent. In the study, with a median follow-up of 4.7 years, patients receiving BiovaxID experienced a 38% lower risk of disease recurrence compared to patients receiving the control vaccine. BiovaxID is the first ever vaccine targeting lymphoma to demonstrate such a disease-free survival benefit.

BiovaxID is individually manufactured from a tissue biopsy obtained from a patient’s own tumor, and selectively targets only the cancerous B-cells, while sparing healthy cells. BiovaxID is highly specific in its anti-lymphoma attack because the vaccine “trains” the body’s own immune system to recognize as foreign the unique protein (idiotype) expressed only on the cancerous B-cells, thus stimulating and recruiting the patient’s own immune system to destroy the cancer cells and potentially prevent recurrence. In contrast, other existing chemotherapeutic and monoclonal antibody therapies destroy most of the healthy B-cells in addition to the cancerous cells, and may result in serious adverse side-effects. Because the BiovaxID vaccine is comprised of the patient’s own cells (autologous), the therapy has been demonstrated to be safe and well-tolerated.

The final vaccine is administered as a subcutaneous injection along with granulocyte-macrophage colony-stimulating factor (GM-CSF) and keyhole limpet hemocyanin (KLH), which together enhances the potency of the immune response induced by BiovaxID. A previous Phase II study demonstrated that patients receiving the BiovaxID vaccine developed a highly-specific immune response against tumor cells, with 95 percent of patients showing significant T-cell activity against their lymphoma and 75 percent of patients showing a humoral immune response. Furthermore, with a median follow-up of 9.2 years, 45 percent of patients remained in continuous first complete remission with a median disease-free survival of 8 years.

“With this vaccine, we’ve now moved into an era where we can safely use a patient’s immune system to effectively fight follicular lymphoma and enhance the response to conventional chemotherapy,” said Stephen J. Schuster, M.D., Associate Professor at the University of Pennsylvania School of Medicine and the study’s lead author. “Because this vaccine uniquely recruits the patient’s immune system to seek and destroy only tumor B-cells, this approach may be applicable to the treatment of other B-cell lymphomas.”

The completed Phase III study achieved its primary endpoint of prolonging disease-free survival in patients who were vaccinated with at least one injection of BiovaxID as compared to patients who received control. In the study, 177 patients with follicular lymphoma who had achieved a complete response to PACE (prednisone, doxorubicin, cyclophosphamide and etoposide) chemotherapy were randomized to the BiovaxID vaccine (Id-KLH/GM-CSF) or to the control study arm (KLH/GM-CSF). As prospectively identified, investigators analyzed the cohort of 117 randomized patients who, as required by the study protocol, maintained a complete response to chemotherapy for at least six months and who received active (N=76) or control (N=41) vaccine. After a median follow-up of 4.71 years (56.6 months, range: 12.6 - 89.3 months), the median disease-free survival in the BiovaxID arm was 44.2 months compared with 30.6 months in the control arm, which is a clinically and statistically significant difference (p=0.045).

BiovaxID demonstrated a favorable safety profile and was very well-tolerated by patients. Further studies are planned to examine the role of BiovaxID in patients with other B-cell lymphomas such as mantle cell lymphoma, chronic lymphocytic leukemia and multiple myeloma. In addition, new lymphoma studies will evaluate the addition of BiovaxID booster maintenance therapy, which is expected to even further improve survival benefits by maximizing the chance of continuously maintaining complete remissions.