Biovest International Gains Key Regulatory Approval for Clinical Trial Sites in Russia; Biovest to open 14 new clinical sites, accelerating patient recruitment.WORCESTER, Mass. -- Biovest International, Inc. (OCTBB: BVTI) has received regulatory approval from the Russian Ministry of Health and Social Development of the Russian Federation to recruit patients for its ongoing Phase 3 clinical trial phase 3 clinical trial Phase 3 study. See Phase study. of BiovaxID(TM) for the treatment of 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 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 (NHL NHL Non-Hodgkin's lymphoma, see there ). The approval lists 14 of the most highly regarded clinical sites in the Russian Federation, most notably including the Russian Cancer Scientific Center in Moscow and the St Petersburg City Clinical Oncology Dispensary dispensary: see clinic. . During the next 18 months, Biovest expects to recruit up to 175 patients from these sites, located throughout the Russian Federation. Recruitment and logistics will be coordinated by ClinStar Europe. "This regulatory approval marks an important milestone in the implementation of our strategy to aggressively complete enrollment for this trial of BiovaxID," said Dr. Steve Arikian, Biovest Chairman and Chief Executive Officer. "Our research indicates that there are a significant number of NHL patients eligible to participate in the testing of our potentially life-saving therapy. With the addition of these sites in the Russian Federation, and with other initiatives underway in the U.S., we feel confident that we are on track to complete enrollment as planned. In anticipation of the influx of clinical samples from these sites, we have already completed the first phase of the expansion of our vaccine manufacturing facility in Worcester, MA." NHL, a cancer of the lymphatic system lymphatic system (lĭmfăt`ĭk), network of vessels carrying lymph, or tissue-cleansing fluid, from the tissues into the veins of the circulatory system. involving a type of white blood cell called a lymphocyte, affects 65,000 new patients each year in the United States alone. Although positive responses are often seen with current treatments such as chemotherapy, radiation, lymphocyte transplantation and monoclonal antibodies, the cancer invariably in·var·i·a·ble adj. Not changing or subject to change; constant. in·var i·a·bil returns and is usually fatal. BiovaxID is not meant to replace existing therapies, but rather to serve as a complement. It is a targeted therapeutic that stimulates the immune system immune systemCells, 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 seek out and destroy only cancerous B-cell lymphocytes without causing damage to normal B-cell lymphocytes or to other healthy cells. Biovest is currently enrolling patients for its BiovaxID Phase 3 study, being run in collaboration with the National Cancer Institute 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. (CRADA CRADA Cooperative Research And Development Agreement ). Patients who believe they may be eligible to participate in this clinical trial with BiovaxID are encouraged to visit www.biovest.com/BIOVAXID/patientinfo.html, or call 877-654-6052. 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 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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