BiovaxIDTreatment for non-Hodgkin's Lymphoma
Biovest Announces Mantle Cell Lymphoma as Next Target Indication for Personalized Cancer Vaccine
Files FDA Application Seeking Orphan Drug Status
TAMPA, Fla. & MINNEAPOLIS--(BUSINESS WIRE)--Jun 22, 2010 - Biovest International, Inc. today announced at the Active Immunotherapeutics Forum in Barcelona, Spain, that the Company is targeting mantle cell lymphoma, in addition to follicular lymphoma, as a next indication for its personalized cancer vaccine, BiovaxID. At the conference, the Company reviewed positive data from an open label Phase II mantle cell lymphoma clinical trial and reported plans to meet with the FDA later this year to discuss a pathway to seek regulatory approval for this hematological indication for which there is no current consensus standard-of-care. Biovest is also currently preparing to seek approvals for BiovaxID for the treatment of follicular non-Hodgkin's lymphoma.
According to Biovest's Vice President, Product Development & Regulatory Affairs, Dr. Carlos F. Santos, "There is an urgent unmet need for new and safe treatment options targeting this incurable, aggressive type of non-Hodgkin's lymphoma, as mantle cell patients are currently limited to few treatment options, often consisting of autologous stem cell transplants or aggressive immunochemotherapies which have significant toxicity and mortality risks. Based on encouraging Phase II data for BiovaxID in the treatment of mantle cell lymphoma, we plan to meet with the FDA to discuss a strategy to seek regulatory approval in the most expedited manner possible. In this study, we observed a tumor-specific immune response in 20 of 23 patients vaccinated with BiovaxID, and consistent with all of our other studies, the vaccine was very well tolerated and safe. As these results were obtained following a rituximab-containing chemotherapy (EPOCH-R), the cellular and humoral responses observed suggest that BiovaxID can augment benefits obtained with a rituximab-containing chemotherapy induction regimen."
Biovest recently filed an application with the FDA seeking Orphan Drug status for BiovaxID for the mantle cell lymphoma indication. This aggressive form of lymphoma constitutes about 6% of all non-Hodgkin's lymphoma cases or approximately 7,800 cases per year in the U.S. and Europe combined.
Dr. Santos also reported that, "The median overall survival for mantle cell lymphoma is approximately 36-months, and our Phase II study showed an 89% overall survival rate at a median follow-up of 46-months (n=26). These encouraging outcomes were originally published in 2005*. Follow-up of these patients is continuing, and we expect a study update to be reported later this year."
* Neelapu. et al. Vaccine-induced tumor-specific immunity despite severe B-cell depletion in mantle-cell lymphoma. Nature Medicine 2005
About Biovest International, Inc.
Biovest International, Inc. is an emerging leader in the field of active personalized immunotherapies targeting life-threatening cancers of the blood system. Developed in collaboration with the National Cancer Institute, BiovaxID is a patient-specific, cancer vaccine, demonstrating statistically significant Phase III clinical benefit by prolonging disease-free survival in vaccinated patients suffering from indolent follicular non-Hodgkin's lymphoma, confirming a previous positive Phase II study. BiovaxID has been granted "Fast-Track" status and Orphan Drug Designation for the treatment of follicular lymphoma by the FDA and Orphan Drug Designation by the European EMEA. A BiovaxID Phase II clinical trial treating patients suffering with mantle cell lymphoma, an incurable and aggressive type of non-Hodgkin's lymphoma, also demonstrated promising results.
Biovest is also developing and marketing a proprietary line of automated hollow fiber bioreactor systems, including the innovative AutovaxID™ which is a production platform for the scalable manufacture of difficult-to-produce biologics including personalized medicines, monoclonal antibodies, cell culture vaccines and therapeutics targeting highly infectious agents. Since 1981, Biovest has been offering its clients a wide range of instrumentation and cell culture contract manufacturing services. Headquartered in Tampa, Florida with its bio-manufacturing facility based in Minneapolis, Minnesota, Biovest is publicly-traded on the Over-the-Counter (OTC) market with the stock-ticker symbol "BVTI", and is a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (Other OTC: "ABPIQ").
For further information, please visit: http://www.biovest.com
Special Note: Biovest expects to soon launch its new website.
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, AutovaxID™, events occurring after dates hereof, 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 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 Biovest 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.
Contact: Biovest International, Inc.
Douglas Calder, Director of Investor Relations & Public Relations
Posted: June 2010
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