Based on Up to 6 Years of Follow-Up, Biovest Announces Favorable Interim Blinded Data for Fast-Tracked Pivotal Phase 3 Clinical Trial of BiovaxID Anti-Cancer Vaccine for Non-Hodgkin's Lymphoma.Company Believes That When The Data is Unblinded it Will Support Planned Application for Accelerated Approval WORCESTER, Mass. -- Biovest International, Inc. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). : BVTI), a majority owned subsidiary 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 ), announced on June 27, 2007 blinded interim data from the start of its fast-tracked pivotal Phase 3 clinical trial phase 3 clinical trial Phase 3 study. See Phase study. of BiovaxID[TM] for 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 (NHL NHL Non-Hodgkin's lymphoma, see there ) from September 2000 through June 2006. This interim blinded data is the most recent data that has been made available to the Company prior to its latest meeting with the Data Monitoring Committee for the ongoing Phase 3 study. The interim blinded data covers 122 patients who have received either BiovaxID or control vaccine. Randomization randomization (ranˈ·d Dr. Steve Arikian, Biovest Chairman and Chief Executive Officer, stated, "Biovest believes these results are consistent with the expected efficacy of BiovaxID vs. control. Moreover, BiovaxID has the longest Phase 3 follow-up data for patients receiving an active immunotherapy active immunotherapy The administration of substances to evoke a protective immune response in the form of specific antibodies. Cf Passive immunotherapy, Vaccine. 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 of any of the Phase 3 Non-Hodgkin's Lymphoma immunotherapy trials ongoing today. We are greatly encouraged by the blinded interim data presented at the Jeffries Healthcare Conference on June 27th, 2007." BiovaxID is an anti-cancer vaccine undergoing testing in a Fast-Tracked pivotal Phase 3 clinical trial for a target indication of Non-Hodgkin's Lymphoma. BiovaxID is a personalized, patient-specific vaccine designed to stimulate the patient's own immune system immune system Cells, cell products, organs, and structures of the body involved in the detection and destruction of foreign invaders, such as bacteria, viruses, and cancer cells. Immunity is based on the system's ability to launch a defense against such invaders. to recognize and destroy residual cancerous B-cells that remain after the patient has undergone chemotherapy. Unlike many other approaches to treating NHL, BiovaxID is designed to target only cancerous B-cells. The BiovaxID Phase 3 clinical trial is being conducted at fourteen U.S. oncology centers and 8 centers in Russia. Applications for accelerated conditional approval of BiovaxID are planned to be submitted to both the Food and Drug Administration (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. ) and European Medicines Agency The European Medicines Agency (EMEA) is a European agency for the evaluation of medicinal products. Until 2004, the European Medicines Agency was known as The European Agency for the Evaluation of Medicinal Products. Roughly parallel to the U.S. (EMEA (Europe, Middle East, Africa) Refers to that region of the world. For example, one might see products packaged differently for the UK, EMEA and Asia Pacific markets. ) by mid-2008. The DMC DMC Devil May Cry (video game) DMC Detroit Medical Center DMC Darryl McDaniels (rapper) DMC Destination Management Company DMC Del Mar College (Corpus Christi, TX) has agreed to serve as a liaison between the Company and the FDA and the EMEA. If conditionally approved, BiovaxID could become commercially available in early 2009. Members of the investment community, the media, and other interested parties can access the PowerPoint presentation and an audio webcast by visiting Accentia's homepage at www.accentia.net, or for audio only, http://www.wsw.com/webcast/jeff18/abpi. The PowerPoint presentation and audio will be available and archived on Accentia's website for 90 days. 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: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 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 for BiovaxID which is a patient-specific anti-cancer vaccine focusing on the treatment of follicular non-Hodgkin's lymphoma. BiovaxID has been granted Fast Track status by the FDA. For further information, visit the Company Web site at www.biovest.com. About Accentia Biopharmaceuticals, Inc. Accentia Biopharmaceuticals, Inc. and its subsidiaries (collectively referred to as the "Company" or "Accentia") is a vertically integrated biopharmaceutical company focused on the development and commercialization of drug candidates that are in late-stage clinical development and typically are based on active pharmaceutical ingredients that have been previously approved by the FDA for other indications. Usually these drug candidates can access the accelerated 505(b)(2) regulatory approval pathway, which is generally less time-consuming and less expensive than the typical 505(b)(1) pathway that must be used for new chemical entities. The Company's lead product candidate is SinuNase(TM), a novel application and formulation of a known therapeutic to treat chronic rhinosinusitis. SinuNase has been granted Fast Track status by the FDA and it is currently in a pivotal Phase 3 clinical trial. During this fiscal year, the Company also plans to file an Investigative New Drug (IND) for a pivotal Phase 3 clinical trial of Revimmune, to treat numerous autoimmune diseases Autoimmune diseases A group of diseases, like rheumatoid arthritis and systemic lupus erythematosus, in which immune cells turn on the body, attacking various tissues and organs. Mentioned in: Complement Deficiencies, Premature Menopause with an initial indication targeting refractory relapsing-remitting Multiple Sclerosis. Revimmune is based on pulsed, ultra-high dosing of a well-known chemotherapeutic agent chemotherapeutic agent An agent used to treat CA, administered in 'regimens'-one or more 'cycles' that combine 3 or more agents over wks; CAs are toxic to any cell with a high rate of proliferation–the CA itself, the GI tract–causing N&V, under a risk management program. Additionally, through an investment strategy, the Company has acquired the majority ownership interest in Biovest International, Inc. ("Biovest"), (BVTI.OB) and a royalty interest royalty interest The proportional ownership interest by the owner of oil and gas rights in income produced by the asset. See also overriding royalty interest. in Biovest's lead drug candidate, BiovaxID[TM] and any other biologic products developed by Biovest. Biovest is currently conducting a pivotal Phase 3 clinical trial for BiovaxID which is a patient-specific anti-cancer vaccine focusing on the treatment of follicular non-Hodgkin's lymphoma. BiovaxID has been granted Fast Track status by the FDA. In addition to these product candidates, the Company has a specialty pharmaceutical business which markets products focused on respiratory disease and an analytical consulting business that serves customers in the biopharmaceutical industry. For further information, visit the Company Web site at 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 Revimmune(TM) SinuNase(TM), BiovaxID(TM), AutovaxID(TM), CRSFungal Profile(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. |
|
||||||||||||||

Printer friendly
Cite/link
Email
Feedback
Reader Opinion