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BiovaxID Yields 89% Survival in Patients with Aggressive Non-Hodgkin's

Personalized anti-cancer vaccine, BiovaxID, stimulates patient's immune system

NEW YORK, NY -- January 24, 2006 -- Accentia Biopharmaceuticals, Inc. and its subsidiary, Biovest International, Inc., report follow-up data to a Phase 2 trial conducted by the National Cancer Institute (NCI) that shows Biovest's BiovaxID yielded an 89% survival rate in mantle cell lymphoma patients.

The median follow-up was 3.8 years. Historically, patients with this type of lymphoma only have had a 50% chance of surviving 3 years and 20% chance of surviving 5 years. BiovaxID, an investigational personalized anti-cancer vaccine, stimulates the immune system to seek out and destroy tumor cells. The data were published in a recent edition of Nature Medicine (Nat Med.2005; 11(9):986-91).

In this single-arm, open-label phase 2 clinical study, patients with untreated mantle cell non-Hodgkin's lymphoma (NHL) were administered six cycles of dose-adjusted EPOCH-R, a chemotherapy regimen that includes RituxanŽ (rituximab). Of the 26 patients in the study, 23 received vaccinations with BiovaxID commencing at least 3 months after completing their last chemotherapy and Rituxan treatments. Upon the 46-month (3.8-year) follow-up, the overall survival rate was 89%.

This study showed that, despite an almost complete depletion of normal B-cell lymphocytes due to EPOCH-R therapy, BiovaxID did induce anti-tumor T-cell lymphocyte responses in most patients. Depletion of normal B-cell lymphocytes is a consequence of the combination of chemotherapy and Rituxan, but not of BiovaxID therapy. Thus, "it is justifiable to administer vaccines in the setting of B-cell depletion, but vaccine boosts after B-cell recovery may be necessary for optimal humoral responses," concluded the investigators.

Lymphocytes are a type of white blood cell. There are two types of lymphocytes: B-cell lymphocytes, which produce antibodies ("humoral" immunity) in response to immune stimulation; and T-cell lymphocytes, which mediate cell responses to immune stimulation ("cellular" immunity). B-cell lymphocytes can undergo malignant transformation to become Non-Hogkin's lymphoma, multiple myeloma or chronic lymphocytic leukemia.

"This is the first human cancer vaccine study to see T-cell responses in the absence of B-cells," said the study's first author, Sattva Neelapu, MD, Assistant Professor in the Department of Lymphoma at the University of Texas M. D. Anderson Cancer Center. "This paves the way to use vaccines in a number of hematological cancers that are treated by eliminating diseased B-cells."

Biovest is now enrolling patients in a pivotal phase 3 trial to test BiovaxID against follicular non-Hodgkin's lymphoma (NHL). Follicular NHL is an indolent (slow-growing) form of lymphoma not considered curable with existing therapies. The impressive findings from the Phase 2 clinical trial using BiovaxID in mantle cell lymphoma suggest the vaccine could potentially be used to treat other types of NHL, in addition to follicular NHL.

Background on immunotherapeutics for non-Hodgkin's lymphoma
Rituxan is a passive immunotherapeutic consisting of a monoclonal antibody administered intravenously. The monoclonal antibody is directed to an antigen (CD20) present on most B-lymphocytes. Accordingly, Rituxan promotes the elimination of cancerous and normal B-lymphocytes bearing this antigen. Rituxan therapy is typically repeated as necessary at intervals in order to control the lymphoma. Annual sales for Rituxan are about $1.5B.

BiovaxID is an active immunotherapeutic that stimulates the production of anti-tumor antibodies and induces a cell-mediated immune response to cancerous B-lymphocytes but not to normal B-lymphocytes. As an active immunotherapeutic, BiovaxID may also provide ongoing immunosurveillance for recurrent tumors.

BiovaxID is a personalized therapeutic comprised of tumor-derived Id protein (tumor-specific antigen) conjugated (linked) to KLH (keyhole limpet hemocyanin) as a carrier protein administered with GM-CSF (granulocyte macrophage colony stimulating factor). GM-CSF is commercially available for other indications. BiovaxID is administered on an outpatient basis in the oncologist's office by means of a subcutaneous injection similar to an insulin shot.

BiovaxID is a premiere example of a targeted therapeutic. It stimulates the immune system to seek out and destroy only cancerous B-cell lymphocytes without collateral damage to normal B-cell lymphocytes or to other cells.

BiovaxID is produced using a hybridoma cell-line developed by and licensed exclusively from Stanford University. BiovaxID contains high-fidelity copies of a tumor-specific antigen that is unique to each patient and that is found exclusively on the surface of each and every malignant B-lymphocyte but not found on the surface of normal B-lymphocytes or other cells. Competing technologies use recombinant techniques, which are copies of just a portion of the tumor-specific antigen. Biovest believes that a complete copy of the tumor specific antigen results in higher rates of immune responses in patients and more robust clinical outcomes, including molecular remissions.


SOURCE: The Investor Relations Group

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