In this single-arm, Phase 2 study, patients with follicular B-cell Non-Hodgkin's Lymphoma (NHL) in continuous first clinical remission six months following PACE chemotherapy were treated with a series of subcutaneous vaccinations of BiovaxID. BiovaxID is comprised of tumor-derived Id protein (tumor antigen) conjugated to KLH as a carrier protein administered with GM-CSF (granulocyte macrophage colony stimulating factor).
With a median follow-up of 9.2 years, 45 percent of patients remained in continuous first clinical remission at their most recent follow-up (either in 2004-2005), and the overall survival rate was 95 percent. Furthermore, median disease free survival for the patient cohort was 96.5 months (8.0 years). Based on historical data these results suggest a clinically significant advance over current expectations of disease progression.
"The results of this Phase 2 study compare very favorably with chemotherapy alone and with CHOP-R where the median disease-free-survival is 2.2 years and 6.9 years respectively. The ongoing Phase 3 trial of BiovaxID vs. non-specific immune stimulation should help to clarify the role of vaccine therapy in patients with follicular lymphoma," said Barry Gause, M.D., co-investigator for the clinical trial at the National Cancer Institute (NCI).
"We are encouraged by these long term follow-up data from our Phase 2 study," said Angelos Stergiou, M.D., Director of Product Development, Accentia Biopharmaceuticals. "These results underscore the potential of BiovaxID as a promising personalized therapeutic vaccine for follicular lymphoma. Patients, physicians, and payors are understandably requesting that, at some point in the battle against cancer, expensive cancer therapeutics need to start to provide cures. Because this disease is considered incurable with existing therapies we are particularly pleased with the reported rate of overall survival without tumor recurrence, which is the gold standard for cancer therapeutics."
BiovaxID is designed to evoke the power of each patient's immune system, priming it to recognize and eliminate cancerous lymphoma cells, while sparing normal B-cells. BiovaxID uses complete high fidelity copies of each patient's unique tumor antigen produced in a hybridoma cell line exclusively licensed from Stanford University. Other vaccines currently being evaluated for the treatment of follicular lymphoma are made by molecular cloning and splicing, and incorporate only a portion of the patient's tumor antigen. 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 all 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 which 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.
About Accentia Biopharmaceuticals, Inc.
Accentia Biopharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of late-stage clinical products in the therapeutic areas of respiratory disease and oncology. Two of these products are SinuNase
About Biovest International
Biovest International, Inc. is a pioneer in the development of advanced individualized immunotherapies for life-threatening cancers of the blood system. Biovest is a majority owned subsidiary of Accentia Biopharmaceuticals, Inc. with its remaining shares publicly traded. Biovest has a foundation in the manufacture of biologics for research and for clinical trials. In addition, Biovest develops, manufactures, and markets patented cell culture systems, including the AutovaxID, which is being developed as an automated vaccine manufacturing instrument. Biovest's therapy for follicular non-Hodgkin's lymphoma is currently in a Phase 3 pivotal clinical trial at over 20 major centers in the U.S. being conducted under a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute. For further information, please visit Biovest's website: http://www.biovest.com.
Statements in this release that are not strictly historical in nature constitute "forward-looking statements." Such statements include, but are not limited to, statements about BiovaxID and any other statements relating to products, product candidates, and product development programs. Such statements may include, without limitation, statements with respect to the Company's plans, objectives, expectations and intentions and other statements identified by words such as "may," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans" or similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause the actual results of Accentia and/or Biovest to be materially different from historical results or from any results expressed or implied by such forward-looking statements. These factors include, but are not limited to, risks and uncertainties related to the progress, timing, cost, and results of clinical trials and product development programs; difficulties or delays in obtaining regulatory approval for product candidates; competition from other pharmaceutical or biotechnology companies; and the additional risks discussed in filings with the Securities and Exchange Commission. All forward looking statements are qualified in their entirety by this cautionary statement, and neither Accentia nor Biovest undertakes any obligation to revise or update this news release to reflect events or circumstances after the date hereof.
Accentia Biopharmaceuticals, Inc., Tampa, FL
Last reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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