Biovest Announces BiovaxID ASCO Abstract Available On-line; NCI to Present Cancer Vaccine Data from Mantle Cell Lymphoma Study

TAMPA, Fla. & MINNEAPOLIS--(BUSINESS WIRE)--May 18, 2012 - Biovest International, Inc. (OTCQB: BVTI), a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (OTCQB: ABPI), today announced that an abstract reporting new data from the BiovaxID® Phase II mantle cell lymphoma clinical trial conducted by the U.S. National Cancer Institute (NCI) is now available on-line with the significance of these results to be presented by the NCI at the 2012 American Society of Clinical Oncology Annual Meeting (ASCO 2012).

The abstract (#2528), titled, “Association of idiotype vaccine-induced T-cell response with improved survival and time-to-next treatment (TTNT) in untreated mantle cell lymphoma (MCL)”, is now available on-line at the ASCO website at: http://abstract.asco.org/AbstView_114_100528.html.

Biovest will further comment on these results following the NCI's presentation at ASCO on Saturday, June 2nd in a poster presentation session from 8:00 am – 12:00 pm CST in Room S405, followed by a poster discussion session at 12:00 pm CST, also in Room S405, at the McCormick Place Convention Center in Chicago.

According to Biovest's President and CEO, Samuel S. Duffey, Esq., "The long-term commitment of the clinicians at the NCI to the potential of cancer vaccines to treat lymphoma is a tribute to the role of our federal government in the ongoing fight against cancer. BiovaxID was developed under a Cooperative Research and Development Agreement (CRADA) between Biovest and the NCI, and Biovest's ongoing progress is to a large degree due to the pioneering vision of NCI clinicians and their effort that has spanned almost two decades. We are indeed proud to have participated in such an important public/private partnership.”

To meet with Biovest at ASCO 2012, please contact Douglas Calder at 813-507-2633 or dwcalder@biovest.com.

About BiovaxID®

Biovest's lead drug product is BiovaxID®, an autologous active immunotherapy (personalized cancer vaccine) for the treatment of certain B-cell subtypes of non-Hodgkin's lymphoma, an incurable form of blood cancer. Over the past decade, two Phase II clinical trials and a Phase III clinical trial have demonstrated strong and cumulative evidence with regards to BiovaxID's safety and efficacy. With regards to safety, all clinical trials to date demonstrate that BiovaxID vaccination is highly safe and poses a nearly vanishingly small toxicity risk relative to approved anti-lymphoma agents. Moreover, BiovaxID provides substantial and durable clinical efficacy with the Phase III clinical trial demonstrating that BiovaxID significantly improves disease-free survival over 15 months (Check/verify extension) in follicular lymphoma and the Phase II mantle cell lymphoma clinical trial demonstrating that BiovaxID induces strong idiotype-specific T-cell responses which correlate with highly-statistically significant overall survival.

About Biovest International, Inc.

Biovest International, Inc. is an emerging leader in the field of active personalized immunotherapies. In collaboration with the National Cancer Institute, Biovest has developed a patient-specific, cancer vaccine, BiovaxID®, with three clinical trials completed, including a Phase III study, demonstrating evidence of safety and efficacy for the treatment of indolent follicular non-Hodgkin's lymphoma.

Headquartered in Tampa, Florida with its bio-manufacturing facility based in Minneapolis, Minnesota, Biovest is publicly-traded on the OTCQB™ Market with the stock-ticker symbol “BVTI”, and is a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (OTCQB: “ABPI”).

For further information, please visit: http://www.biovest.com

Forward-Looking Statements:

Statements in this presentation/interview that are not strictly historical in nature constitute "forward-looking statements.” Such statements include, but are not limited to, statements about Biovest and its product candidate, BiovaxID® and any other statements relating to products, product candidates, product development programs, the FDA, the EMA, Health Canada 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. In particular (and without limitation), statements regarding the timing of anticipated filing of a Marketing Authorization Application for BiovaxID with the EMA or a New Drug Submission for BiovaxID with Health Canada, pre-filing meetings with the FDA or other jurisdictions and/or commercial plans reflect current expectations but are subject to inherent risks of delay in compilation and finalization of all components of the licensing application. 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.
Corporate Contact:
Douglas Calder, 813-864-2558
Vice President, Strategic Planning & Capital Markets
dwcalder@biovest.com

 

Posted: May 2012

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