Accentia Biopharmaceuticals Announces Unblinding and Analysis of Fast Tracked Phase 3 Trial for BiovaxID.After 15 Years of Clinical Studies, Personalized Anti-Cancer Vaccine for Non-Hodgkins Lymphoma Appears to Offer Hope of a Cure for Otherwise Fatal Cancer 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 ) majority owned subsidiary, Biovest International, Inc. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). :BVTI), announced today its regulatory strategy for its Fast Tracked Phase 3 clinical trial phase 3 clinical trial Phase 3 study. See Phase study. of its anti-cancer vaccine for the treatment of 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. The trial was begun by the National Cancer Institute in 2000. The Company performed a data lock in September 2007 and anticipates having a data analysis of unblinded data on the primary endpoint of disease-free survival for BiovaxID completed and publicly disclosed by March of 2008. BiovaxID has been in human clinical studies since 1993. Non-Hodgkins Lymphoma is an 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. but typically fatal cancer despite recent advances including monoclonal antibodies like Rituxan. Independent clinical studies at the National Cancer Institute, Stanford University, and 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 have demonstrated that a BiovaxID formulation used in conjunction with standards of care Standards of care are medical or psychological treatment guidelines, and can be general or specific. They specify appropriate treatment protocols based on scientific evidence, and collaboration between medical and/or psychological professionals involved in the treatment of a given can have substantial clinical benefit measured in terms of additional years of disease free survival and in some cases, with over 9 years of follow-up, long term complete remissions which appear to be cures. BiovaxID is a targeted therapeutic which has an outstanding safety profile because it does not cause collateral damage to normal, non-cancerous cells. In June 2007, the independent Data Monitoring Committee (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) ) for BiovaxID reviewed the available unblinded clinical trial data from the BiovaxID Phase 3 trial. The DMC confirmed that at that time there were no safety concerns. Based on their review of the available data, the DMC recommended implementation of a data lock on the clinical trial data to take effect in September 2007 and requested that an interim analysis of the study's efficacy endpoints and overall safety profile be performed. Accordingly, the Company has temporarily halted recruitment, randomization randomization (ranˈ·d tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. on an unblinded basis pursuant to a compassionate use exemption. Subject to the completion of the anticipated analysis of the unblinded trial data, the Company plans to seek accelerated conditional approval for BiovaxID in the United States, Europe and Switzerland. The Company anticipates scheduling meetings with 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. and 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. to review its revised strategy for early approval of BiovaxID. BiovaxID[TM] is a personalized, patient-specific therapeutic vaccine designed to stimulate the patient's own immune system to recognize and destroy cancerous B-cells that may remain in the body or may arise after the patient has been treated with chemotherapy. Unlike many other approaches to treating NHL NHL Non-Hodgkin's lymphoma, see there , BiovaxID[TM] is designed to kill only cancerous B-cells. The Company acquired its rights to BiovaxID from the National Cancer Institute ("NCI See Liberate. ") through 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. . The NCI commenced the Phase 2 Clinical Trial phase 2 clinical trial Phase 2 study. See Phase study. for BiovaxID 1993 and the pending Phase 3 Clinical Trial was commenced in 2000. BiovaxID[TM] is a therapeutic, anti-cancer vaccine for the indication 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 (NHL). Additionally, we anticipate that BiovaxID could potentially be used to treat other types of B-cell cancers such as Mantle Cell Lymphoma Mantle cell lymphoma (MCL) is one of the rarer of the non-Hodgkin's lymphomas, comprising about 6% of NHL cases.[1] There are only about 15,000 patients presently in the U.S. (The incidence seems to be somewhat higher in Europe. , Chronic Lymphocytic Leukemia chronic lymphocytic leukemia n. Abbr. CLL Lymphocytic leukemia occurring mainly in older adults, characterized by slow onset and gradual progression of symptoms. and Multiple Myeloma. 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 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 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 with an initial indication targeting refractory relapsing-remitting Multiple Sclerosis. Revimmune is based on pulsed, ultra-high dosing of a well-known chemotherapeutic agent 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 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 BiovaxID and AutovaxID and any other statements relating to Biovest's products, product candidates, and product development programs. Such statement 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 Biovest's actual results 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 Biovest's 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 Biovest's filings with the Securities and Exchange Commission. All forward looking statements are qualified in their entirety by this cautionary statement, and Biovest undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. |
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