Biovest International Presents Long Term Follow up Data on BiovaxID(TM) Treatment of Follicular Non-Hodgkin's Lymphoma at American Society for Clinical Oncology Meeting.WORCESTER, Mass. -- Data Suggest Possible Utility of Molecular Remission as Early Indicator of Efficacy in Clinical Trial Biovest International (OTCBB OTCBB See OTC Bulletin Board (OTCBB). : BVTI) delivered a presentation entitled "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. Vaccine Therapy vaccine therapy A therapeutic strategy to boost the immune response against a particular pathogen to such degree that the vaccine alone is enough to treat the Pt of 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, in First Remission: Association of t(14;18) and Disease Free Survival in a Phase II Cohort" at the annual meeting of the American Society for Clinical Oncology in Atlanta, GA on June 3, 2006. The presentation was authored by BL Gause, SS Neelapu, CM Cohen cohen or kohen (Hebrew: “priest”) Jewish priest descended from Zadok (a descendant of Aaron), priest at the First Temple of Jerusalem. The biblical priesthood was hereditary and male. , LM Katz, TM Watson, AM Stergiou and LW Kwak, from the National Cancer Institute, MD Anderson Cancer Center and Biovest International. The data, representing follow up analysis of patients with follicular lymphoma treated with BiovaxID(TM) in a phase 2 trial, showed that 9.2 years after treatment 95% of BiovaxID(TM) treated patients were still alive and 45% remained disease free. Dr. Steve Arikian, Biovest CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. commented: "In this important study, we were able to preview the utility of the very sensitive t(14;18) chromosomal translocation In genetics, a chromosome translocation is a chromosome abnormality caused by rearrangement of parts between nonhomologous chromosomes. It is detected on cytogenetics or a karyotype of affected cells. marker of molecular remission. Biovest recently received agreement from 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. to utilize patient data for this marker as a secondary endpoint of efficacy in our ongoing phase 3 trial, so we were keenly interested in ascertaining its utility in this patient cohort. We already knew that 73% of evaluable BiovaxID treated patients achieved molecular remission in that trial. This follow up data showed that 53% of the patients who achieved molecular remission remained in clinical remission - that is they were clinically disease free - 9.2 years later. In contrast, for patients who did not achieve molecular remission, none were disease free at this follow up time. While the total number of patients treated was small, we are very encouraged by this result." Dr. Arikian continued: "This study supports a growing body of data suggesting the importance of molecular remission as a sensitive and early indicator of clinical utility in this disease. We expect that the high rate of molecular remissions - and the associated long clinical remissions- seen in our phase 2 trial will be seen in our ongoing phase 3 trial. We are hopeful that the combined use of both clinical and molecular indicators of efficacy in our phase 3 trial will enable us to confirm the utility of BiovaxID(TM) sooner than we could otherwise." Dr. Larry Kwak, a co-author of the study and Chairman of the Department of Lymphoma and Myeloma myeloma /my·elo·ma/ (mi?e-lo´mah) a tumor composed of cells of the type normally found in the bone marrow. giant cell myeloma see under tumor (1). at The University of Texas M.D. Anderson Cancer Center in Houston commented: "We have had a long standing interest in utilizing the t(14;18) molecular marker Molecular marker is a term with a number of uses. It is any kind of molecule indicating the existence of a chemical or physical process. In particular, in the fields of geology and astrobiology, biomarkers (also known as biosignatures) are sometimes understood as molecules as a prognostic indicator of therapeutic utility in this class of cancers. Our most recent analysis of the original National Cancer Institute phase 2 patients treated with BiovaxID(TM) is a positive sign that use of this marker will accelerate the availability of potentially life saving therapies for non-Hodgkin's lymphomas." More than 20 clinical sites within the U.S. are currently enrolling patients with follicular lymphoma in the BiovaxID(TM) Phase 3 trial. Patients interested in receiving more information about the Phase 3 trial can call toll free 877-654-6052, or visit the Company Web site www.biovest.com/BIOVAXID/patientinfo.html. About Biovest International, Inc. Biovest International, Inc. is a pioneer in the development of advanced individualized in·di·vid·u·al·ize tr.v. in·di·vid·u·al·ized, in·di·vid·u·al·iz·ing, in·di·vid·u·al·iz·es 1. To give individuality to. 2. To consider or treat individually; particularize. 3. immunotherapies for life-threatening cancers of the blood system. Biovest is a majority-owned subsidiary majority-owned subsidiary A firm in which more than 50% of outstanding voting stock is owned by the parent company. 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 innovative AutovaxID(TM) C, which is being developed as an automated vaccine-manufacturing instrument and for production of cell-based materials and therapeutics. Biovest's therapy for 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-Hodgkin's lymphoma is currently in a pivotal Phase 3 clinical trial phase 3 clinical trial Phase 3 study. See Phase study. being conducted under a Cooperative Research and Development Agreement “CRADA” redirects here. For other uses, see CRADA (disambiguation). A Cooperative Research and Development Agreement (CRADA) is an agreement between a government agency and a private company to work together. (CRADA CRADA Cooperative Research And Development Agreement ) with the National Cancer Institute at more than 20 major medical centers throughout the U.S. For further information, visit Biovest's Web site: www.biovest.com. 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(TM) 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(TM) is a patient-specific anti-cancer vaccine for the treatment of follicular non-Hodgkin's lymphoma. BiovaxID(TM), 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, visit Accentia's Web site: www.accentia.net. 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 BiovaxID(TM) 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. |
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