Healthcare Industry News: sinusitis
News Release - May 11, 2006
FDA Grants Accentia Biopharmaceuticals, Inc.'s Majority-Owned Subsidiary Fast Track Status for BiovaxID(TM)Personalized Vaccine for Follicular Non-Hodgkin's Lymphoma Receives Fast Track Status from FDA
TAMPA, Fla.--(HSMN NewsFeed)--May 11, 2006--A majority-owned subsidiary of Accentia Biopharmaceuticals Inc. (NASDAQ: ABPI ), Biovest International, Inc. (OTCBB: BVTI ), has been notified that the United States Food and Drug Administration (FDA) granted Fast Track status to BiovaxID, the Company's personalized biologic therapeutic for follicular non-Hodgkin's lymphoma. The targeted anti-cancer immunotherapy, now undergoing pivotal Phase 3 clinical trials at over 20 major medical centers throughout the U.S., showed extremely positive Phase 2 results - more than 9 years after treatment 95% of BiovaxID treated of treated patients are still alive.
Under the FDA Modernization Act of 1997, a promising therapy may be designated "Fast Track" provided the agency feels that the drug candidate has the potential to address unmet medical needs by treating serious or life-threatening conditions. Granted Fast Track status for BiovaxID, Biovest is now eligible to submit a biologics license application (BLA) on a rolling basis, allowing the FDA to review sections of the BLA in advance of receiving the Company's full submission, and permitting Biovest to apply for the expedited review of its BLA.
Steve Arikian, M.D., Chairman and Chief Executive Officer of Biovest, commented:
"We are extremely pleased at this very positive FDA action. In its letter to us the FDA has indicated that BiovaxID shows the potential to treat a serious and life threatening condition and that our clinical development plan is designed to demonstrate an improvement in disease free survival and an effect on overall survival. This action by the FDA will help us bring BiovaxID to patients more quickly by allowing us to move our regulatory filing forward in stages."
Non-Hodgkin's lymphoma, a cancer of the lymphatic system involving a type of white blood cell called a lymphocyte, is found in 65,000 new patients each year in the United States. And although good response rates are often seen with current treatments like chemotherapy, radiation, lymphocyte transplantation and monoclonal antibodies, the cancer invariably returns and is usually ultimately fatal.
Dr. Arikian adds:
"BiovaxID is not meant as a replacement for existing therapies, but rather as a complement. A premier example of a targeted therapeutic BiovaxID stimulates the immune system to seek out and destroy only cancerous B-cell lymphocytes without causing damage to normal B-cell lymphocytes or to other cells."
Biovest is currently enrolling patients for its BiovaxID Phase 3 study. The study is being run in collaboration with the National Cancer Institute through a Cooperative Research and Development Agreement (CRADA).
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 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 centers in the U.S., and is being conducted under a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute. 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 product, in development to treat chronic sinusitis (rhinosinusitis), is a novel application and formulation of a known anti-fungal licensed from the Mayo Foundation for Medical Education and Research. BiovaxID is a patient-specific anti-cancer vaccine focusing on the treatment of follicular non-Hodgkin's lymphoma. BiovaxID, which is being developed by Accentia 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 the Company Web site at www.accentia.net.
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, AutovaxID and any other statements relating to products, product candidates, and product development programs of Accentia and/or Biovest. Such statement may include, without limitation, statements with respect to either 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 actual results of either Accentia 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 Accentia's and/or 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 filings of Accentia and Biovest 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.
Source: Accentia Biopharmaceuticals
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