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BiovaxID?yields 89 percent survival in patients with aggressive non-Hodgkins

Accentia Biopharmaceuticals, 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 Rituxan® (rituximab). Of the 26 patients in the study, 23 received vaccinations with BiovaxID commencing at least three 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-Hogkins
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Source:The Investor Relations Group


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