Healthcare Industry News: Accentia Biopharmaceuticals
News Release - October 19, 2006
New Landmark Study Shows the Use of a BiovaxID Formulation Improves Disease Free survival in 80% of Patients Whose Cancer has Relapsed after Chemotherapy Administered With or Without RituxanTAMPA, Fla.--(HSMN NewsFeed)--Accentia Biopharmaceuticals Inc. (NASDAQ:ABPI ) reports that a new study by Dr. Susana Inoges and colleagues at the University of Navarra (Journal of the National Cancer Institute, 98:1292-1301, Sept 20, 2006) has shown that the administration of a BiovaxID(TM) formulation given to patients with relapsed Follicular Non-Hodgkins Lymphoma following chemotherapy, with or without concomitant Rituxan(TM)(1), can induce complete long-lasting remissions. Moreover, these second remissions are uniquely characterized by a duration that exceeds the duration of the first remission (P less than .0001). In the study, 80% of patients achieved an immune response to the Biovaxid formulation, and among these responders, the median time of complete tumor remission has not been reached after 33 months of mean follow-up.
In an accompanying editorial, Idiotype vaccination in follicular lymphoma: knocking on the doorway to a cure, Dr. Dan Longo, National Institutes of Health, characterized the results as "remarkable". "Among the 20 immunologic responders, the median duration of the second complete response has not been reached after nearly 3 years of follow-up (durations range from 20+ to 51+ months) and in every case, the second remissions have been longer than the initial remissions," commented Dr. Dan Longo. "By contrast, all five immunologic non-responders have relapsed, and in every case their second remission was shorter than their first. Long second remissions do not occur at this rate, even after high-dose therapy and autologous hematopoietic stem cell transplant" (Journal of the National Cancer Institute, 98:1263-1265, Sept 20 , 2006).
(1) Rituxan is a registered trademark of Biogen Idec.
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(TM) and BiovaxID(TM). The Company's SinuNase product, in development to treat chronic sinusitis (rhinosinusitis), is a novel application and formulation of a known anti-fungal licensed from the Mayo Foundation for Medical Education and Research. BiovaxID is a patient-specific anti-cancer vaccine focusing on the treatment of follicular non-Hodgkin's lymphoma. BiovaxID, which is being developed by Accentia's subsidiary Biovest International, Inc., is currently in a Phase 3 clinical trial. In addition, Accentia's growing specialty pharmaceutical business, TEAMM Pharmaceuticals, has a portfolio of currently marketed products plus a pipeline of additional products under development by third parties. For further information, please visit our web site: www.accentia.net.
About Biovest International, Inc.
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. (NASDAQ: ABPI ), with its remaining shares publicly traded. Biovest has a foundation in the manufacture of biologics for research and clinical trials. In addition, Biovest develops, manufactures and markets patented cell culture systems, including the innovative AutovaxID(TM), which is being developed as an automated vaccine manufacturing instrument and for production of cell-based materials and therapeutics. Biovest's therapy for follicular non-Hodgkin's lymphoma is currently in a Phase 3 pivotal clinical trial at more than 20 major medical centers throughout the U.S. For further information, visit the Company Web site at www.biovest.com (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 SinuNase(TM), BiovaxID(TM), AutovaxID(TM) and any other statements relating to products, product candidates, product development programs the FDA or clinical trial process including the commencement, process or completion of clinical trials or the regulatory process. 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 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 Accentia undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof.
Source: Accentia Biopharmaceuticals
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