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 Rituxan.TAMPA, Fla. -- Accentia Biopharmaceuticals Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :ABPI ABPI Association of the British Pharmaceutical Industry ABPI Associação Brasileira da Propriedade Intelectual (Brazilian Intellectual Property Association; Brazil) ABPI Ankle Brachial Pressure Index ) reports that a new study by Dr. Susana Inoges and colleagues at the University of Navarra The University confers 27 official degrees and administers more than 300 postgraduate programs (including 33 doctoral programs and 13 master's programs) through 10 schools, 2 superior colleges, 2 university schools, its world-renowned graduate business school, IESE ("Instituto de (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 fol·lic·u·lar adj. 1. Relating to, having, or resembling a follicle or follicles. 2. Affecting or growing out of a follicle or follicles. 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<.0001). In the study, 80% of patients achieved an immune response immune response n. An integrated bodily response to an antigen, especially one mediated by lymphocytes and involving recognition of antigens by specific antibodies or previously sensitized lymphocytes. 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 id·i·o·type n. A determinant that confers on an immunoglobulin molecule an antigenic individuality that is analogous to the individuality of the molecule's antibody activity. vaccination in follicular lymphoma follicular lymphoma n. See nodular lymphoma. follicular lymphoma Follicle center lymphoma A heterogeneous group of NHLs arising in follicular center cells, which comprises 50% of all NHLs in adults–US, : 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 autologous /au·tol·o·gous/ (aw-tol´ah-gus) related to self; belonging to the same organism. au·tol·o·gous adj. 1. hematopoietic stem cell Hematopoietic stem cell A cell that can develop into any type of specialized blood cell. Mentioned in: Umbilical Cord Blood Banking 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 chronic sinusitis Chronic sinus infection ENT Inflammation of the sinuses that empty into the nasal cavity Etiology Allergic rhinitis, nasal obstruction, deviated nasal septum, tooth abscesses, URIs (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 non-Hodg·kin's lymphoma n. Any of various malignant lymphomas characterized by the absence of Reed-Sternberg cells. Non-Hodgkin's lymphoma . BiovaxID, which is being developed by Accentia's subsidiary Biovest International, Inc., is currently in a Phase 3 clinical trial phase 3 clinical trial Phase 3 study. See Phase study. . 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>. Forward-Looking Statements 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 FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. 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. |
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