Biovest International Reaffirms Its Confidence in the Ongoing Unblinding of the BiovaxID(TM) Phase 3 Data Based on a Track Record of Eliciting an Immune Response in 80% of Patients.TAMPA, Fla. -- Biovest International, Inc. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). :BVTI) announced today that it is reaffirming its confidence in the results of the ongoing unblinding of the BiovaxID[TM] pivotal Phase 3 results. Yesterday, Genitope Corporation announced that its recombinant partial copy of the tumor specific antigen for non-Hodgkins lymphoma, MyVax[R], elicited 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. in just 40% of patients and that its Phase 3 clinical study of MyVax failed to meets its primary endpoint of statistically significant progression free survival vs control group. Biovest's BiovaxID differs significantly from MyVax and other recombinant products. BiovaxID is a hybridoma-produced full copy of the tumor specific antigen that has demonstrated in a Phase 2 study at the National Cancer Institute and in an independent study 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 to elicit an immune response in 80% of patients. According to according to prep. 1. As stated or indicated by; on the authority of: according to historians. 2. In keeping with: according to instructions. 3. Dr. Steve Arikian, M.D., Chairman and 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. of Biovest International, "We believe that a strong immune response from a broad population of lymphoma patients requires a complete copy of the tumor specific antigen to induce long lasting disease free survival. This is why we have consistently demonstrated an 80% immune response." Accordingly, Biovest reaffirms its confidence in the clinical efficacy of BiovaxID and that the ongoing unblinding will demonstrate a statistically significant effect. Biovest believes that the unblinding of its pivotal Phase 3 study will provide strong evidence supporting the appropriateness of BiovaxID for accelerated approval in the U.S. under subpart E and conditional approval in the EU. The company is also examining molecular remission data for the purposes of detecting early recurrence of the cancer prior to clinical evidence on physical exam and CT scans. The Company believes that this molecular data will provide additional evidence of efficacy for BiovaxID. The Company intends to prepare an application for accelerated and conditional approval in the U.S. and EU, respectively. The public release of the unblinding of the BiovaxID data is expected in April, 2008. 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., (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 marketed as an automated vaccine manufacturing instrument and for production of cell-based materials and therapeutics. Biovest is currently conducting a pivotal Phase 3 clinical trial phase 3 clinical trial Phase 3 study. See Phase study. for BiovaxID(TM), which is a patient-specific anti-cancer vaccine focusing on the treatment of 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 . BiovaxID(TM) has been granted Fast Track status by 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. . For further information, visit the Company Web site at 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 Revimmune(TM), SinuNase(TM), BiovaxID(TM), AutovaxID(TM), SinuTest(TM) and any other statements relating to products, product candidates, product development programs, the FDA or clinical study 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. The product names used in this statement are for identification purposes only. All trademarks and registered trademarks are the property of their respective owners. |
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