Biovest International submits amendment request to FDA for use of molecular remission data

Accentia Biopharmaceuticals, Inc. (NASDAQ: ABPI) and its subsidiary, Biovest International, Inc. (OTCBB:BVTI), announces that it has made a formal amendment request to the FDA seeking to use pivotal Phase 3 data on molecular remissions, combined with physical examination and CT scan evidence of gross tumor remission, to gain conditional approval of BiovaxID for treating follicular non-Hodgkin's lymphoma. Biovest has proposed that the data be analyzed as part of the annual Data Safety Monitoring Board (DSMB) review of its clinical trial. If the data show a statistically significant difference in combined molecular and clinical tumor-free survival, then Biovest intends to request that the FDA consider granting conditional approval to BiovaxID. This approval, if granted, would require the company to complete the ongoing Phase 3 study as a condition to continued marketing of BiovaxID.

Non-Hodgkin's lymphoma (NHL) is a cancer of the lymphatic system involving a type of white blood cell called a lymphocyte. Because of a characteristic chromosomal abnormality in the cancer cells in NHL, as few as 1 malignant lymphocyte in 100,000 normal cells can be detected in the blood using a molecular test known as polymerase chain reaction (PCR). The absence of detectable cancer cells in the blood, based on this sensitive test, is referred to as molecular remission. The preponderance of published clinical studies using a variety of therapeutic regimens has demonstrated a strong correlation between molecular remission and the length of tumor-free survival.

"In the National Cancer Institute's (NCI) Phase 2 study of BiovaxID, all the evaluable patients had molecular evidence of residual cancer following chemotherapy. However, after the administration of BiovaxID, 70% of these patients cleared their blood of residual cancer cells," said Steve Arikian, M.D., Biovest Chairman and CEO. "Long-term follow-up of patients who achieved a molecular remission with BiovaxID

Contact: Carl Cohen, Ph.D
508-793-0001 X 448
The Investor Relations Group

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