BIOVEST TO EXPAND PRODUCTION OF NCI VACCINE IN PIVOTAL PHASE III STUDY FOR NON-HODGKINS LYMPHOMA
Minneapolis, MN -- October 16, 2003, Biovest International announced the completion of five million dollars of capital investment under its April 10, 2003, Investment Agreement with Accentia, Inc., a Hopkins Capital Group portfolio company. The recently received capital represents the initial tranche of a multi-year, twenty million dollar investment commitment.
Biovest, which is designated the National Cell Culture Center by the National Institutes of Health, is utilizing a portion of this investment to expand its core businesses of contract biologic production and the manufacture and sale of proprietary cell culture production equipment.
Additionally, a portion of the invested capital is being used to support ongoing clinical trials of its tumor specific therapeutic cancer vaccine being developed to potentially empower the patient's own immune system to effectively fight non-Hodgkin's lymphoma. In cooperation with the National Cancer Institute (NCI), the Biovest therapeutic cancer vaccine is currently in a pivotal Phase III clinical trial for low-grade follicular B-cell lymphoma. Biovest believes that an autologous tumor-specific antigen produced from each patient's tumor may offer potential advantages in cancer treatment. Clinical studies to date, including long-term (median follow-up of greater than seven years) follow-up of phase II patients suggests that the vaccine is non-toxic, a supplement to induction chemotherapy, highly targeted, and results in tumor-specific immune responses in 90% of patients. Moreover, initial vaccination, without any boosters in subsequent years, results in unprecedented tumor-free survival of approximately 50% and overall survival of 80% at seven years.
Stephane Allard, MD the President and CEO of Biovest stated, "Biovest's investment relationship with Accentia is allowing us to accelerate our vaccine development. As a result, we are currently closing on a new 14,500 square foot phase III therapeutic facility which will be reconfigured specifically to produce the Biovest personalized therapeutic cancer vaccine required to complete our pending pivotal Phase III trial. The Biovest proprietary hollow-fiber bioreactor technology has successfully made vaccine for every patient in the ongoing phase III study sponsored by the NCI."
Larry W. Kwak, MD, PhD, NCI is the developer of the Biovest vaccine
and Principal Investigator of the pivotal Phase III trial. " Information
about patient enrollment in this clinical trial is available by calling
NCI's toll-free number 1-888-NCI-1937 and/or by visiting the NCI Web
site at: http://www.ncilymphomavaccine.org/ or http://www.nci.nih.gov/search/clinical_trials/search_clinicaltrialsadvanced.aspx
(type NCI-00-C-0050 in the Protocol ID field and then click on "Search
Now")
Larry Kwak, MD, PhD stated, " I am pleased that Biovest has partnered
with Accentia to develop this promising technology. I believe that an
autologous vaccine for non-Hodgkin's lymphoma produced from a hybridoma
using the Biovest bioreactor yields a complete tumor-specific antigen.
This vaccine may offer clinical advantages over other vaccine approaches
such as recombinant techniques, which are typically based on just a
portion of the tumor antigen. The encouraging results with the Biovest
personalized vaccine developed in cooperation with the NCI in earlier
clinical studies should not be extrapolated to recombinant techniques."
Chris Kyriakides, M.D., Vice-Chairman of Biovest said, "Biovest
believes that its patented technology efficiently creates the whole
tumor antigen from hybridomas reducing dependence on alternate production
techniques that use recombinant technology to produce a portion of the
tumor-specific antigen grafted onto a standard fragment, such as those
used by Genitope, Favrille, and other companies."
Biovest International, Inc. is a biotechnology company that develops, manufactures and markets cell culture systems. For the past 10 years the company has been designated, by the National Institutes of Health, as the National Cell Culture Center (NCCC). Through its proprietary technology, Biovest provides cell culture services to research institutions, biotechnology companies and the pharmaceutical industry. The company is the holder of a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute for the commercialization of a personalized biologic therapeutic cancer vaccine for the treatment of non-Hodgkin's lymphoma. For more information on Biovest, go to www.biovest.com.
Accentia, Inc. is a vertically-integrated specialty biopharmaceutical company that provides comprehensive biopharmaceutical services, including product commercialization, clinical manufacturing, contract sales, and product distribution. For more information on Accentia, go to www.accentia.net.
Hopkins Capital Group, LLC is a private equity fund focused on the development
of early-stage significant and disruptive technologies in healthcare.
For more information on Hopkins Capital Group, go to www.hopkinscap.com.
The information in this press release includes certain forward-looking statements concerning the Company's current expectations regarding future events including but not limited to the ongoing and prospective development of the CRADA-based vaccine, ongoing clinical trials and its plans regarding its manufacturing operations. Due to the nature of the product development and the regulatory approval process, the forward-looking statements contained in this press release are subject to risks and uncertainties, including those reflected in the Company's filings with the Securities and Exchange Commission, particularly its Annual Report on Form 10-K for the year ended September 30, 2002.
L.G. Zangani, LLC provides financial public relations service to the Company. As such L.G. Zangani, LLC and/or its officers, agents and employees, receives remuneration for public relations and or other services in the form of monies, capital stock in the Company, warrants or options to purchase capital in the Company.
