Biovest International's Phase 3 Therapy for Follicular Lymphoma Receives Independent Support From Newly Published Phase 2 Trial Data.Study using hybridoma-derived vaccine shows first-ever improvement in disease-free-survival following prior relapse for this disease WORCESTER, Mass. -- Biovest International, Inc. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). : BVTI) announced that a publication in the September 20th issue of the Journal of the National Cancer Institute provides support for its ongoing phase 3 trial of BiovaxID, an autologous autologous /au·tol·o·gous/ (aw-tol´ah-gus) related to self; belonging to the same organism. au·tol·o·gous adj. 1. immunotherapy 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 non-Hodg·kin's lymphoma n. Any of various malignant lymphomas characterized by the absence of Reed-Sternberg cells. Non-Hodgkin's lymphoma . The publication, entitled "Clinical Benefit Associated With Idiotypic Vaccination of Patients With 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, " by Susana Inoges, et al (Journal of the National Cancer Institute, Vol. 98, No 18, 2006, pp1292-1301), was based on research conducted at the Oncology Division of the University of Navara, in Pamploma, Spain. In the study 25 patients with indolent indolent /in·do·lent/ (in´dah-lint) 1. causing little pain. 2. slow growing. in·do·lent adj. 1. Disinclined to exert oneself; habitually lazy. 2. follicular lymphoma who had relapsed after chemotherapy (including approximately 1/2 who had received Rituxan therapy) were put into a second remission with CHOP chemotherapy followed by vaccination with anti-idiotype vaccine. Of the 25 patients immunized, 20 developed a measurable anti-idiotype 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. . All of the responders with sufficient follow up for a comparison to be made experienced a second complete response that was significantly longer (P<0.0001) than their first response and than the median length of typical CHOP-induced second complete responses. The authors note that it is highly unusual if not unique that a second remission in this disease would be longer than the first, suggesting that this hybridoma-derived anti-idiotype immunotherapy represents a new treatment paradigm for this disease. Significantly, the median DFS (Distributed File System) An enhancement to Windows NT/2000 and 95/98 that allows files scattered across multiple servers to be treated as a single group. With Dfs, a network administrator can build a hierarchical file system that spans the organization's LANs and for the second vaccine-associated remission has not been reached, but is >33 months; median DFS for 1st remission was 17 months. The authors conclude that "Specific immune response was associated with a dramatic and highly statistically significant increase in disease free survival. This is the first formal demonstration of clinical benefit associated with the use of a human cancer vaccine." (J Natl Cancer Inst 2006; 98:1292-1301). 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. and Chairman commented, "We are very pleased with the results of this new phase 2 trial from the University of Navara. This group used the same hybridoma hybridoma /hy·brid·o·ma/ (hi?brid-o´mah) a somatic cell hybrid formed by fusion of normal lymphocytes and tumor cells. hy·brid·o·ma n. method to produce their anti-idiotype vaccines as we use at Biovest. We are confident that these impressive results are supportive of the great potential value of our therapy, and even suggest a benefit for extended booster immunizations, for which Biovest will be well prepared when we go to market. We are especially pleased to see that the study suggests a benefit of this therapeutic approach even after relapse following administration of Rituxan. This independent validation comes at a pivotal point in out own trial, as we ramp up Ramp Up To increase a company's operations in anticipation of increased demand. Notes: A company might 'ramp up' operations if they just signed a contract creating substantially more demand for their product. See also: Demand, Economies of Scale patient recruitment and prepare for commercial launch following approval. Our unique ability to efficiently manufacture the active component of these vaccines in our AutovaxID instruments will enable us to meet what we believe will be a significant demand in the worldwide market." 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 majority-owned subsidiary A firm in which more than 50% of outstanding voting stock is owned by the parent company. of 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 ), 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 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 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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