PRESS RELEASE:
FDA Gives Permission to Use Very Sensitive Molecular Evidence of Cancer in BiovaxID Pivotal Phase 3 Clinical Trial:
Tuesday May 16, 9:43 am ET
Biovest Intends to Use Blood Test to File Application for Accelerated Approval
Analysis of Combined Clinical Plus Molecular Remission May Provide Early Demonstration of Efficacy for Novel Anti-Cancer Immunotherapy
WORCESTER, Mass.--(BUSINESS WIRE)--May 16, 2006--Biovest International, Inc. (OTCBB: BVTI - News) has been notified by the United States Food and Drug Administration (FDA) that its proposal to utilize molecular remissions data as a new secondary endpoint in its ongoing clinical trial is acceptable to the agency. Biovest is conducting a pivotal Phase 3 trial evaluating BiovaxID(TM), the Company's personalized, targeted anti-cancer immunotherapy for treatment of follicular non-Hodgkin's lymphoma at over 20 major medical centers throughout the U.S. Biovest previously reported positive Phase 2 results for BiovaxID - more than 9 years after treatment 95% of BiovaxID treated patients are still alive. Approximately 70 % of evaluable patients showed no evidence of tumor cells when measured using highly precise molecular remissions data.
Biovest had asked the FDA to review a request to collect data on molecular remissions, combined with physical examination and CT scan evidence of gross tumor remission as part of a revised secondary endpoint for its ongoing trial. Biovest had also proposed that the data be analyzed as part of annual Data Safety Monitoring Board (DSMB) reviews of its clinical trial. Biovest believes that recent advancements in molecular analysis, which enable the detection of small numbers of cancer cells in the blood, can be used to provide a sensitive and early indication of tumor remission. Biovest believes this could lead to a faster demonstration of statistically significant benefit of BiovaxID and to earlier FDA approval of BiovaxID. If the data demonstrate a statistically significant benefit of BiovaxID on combined molecular and clinical tumor-free survival, Biovest will request that the FDA grant approval to BiovaxID. Such approval would allow the Company to commence commercial marketing of BiovaxID while it completes its ongoing Phase 3 study.
Non-Hodgkin's lymphoma (NHL) is a cancer of the lymphatic system involving a type of white blood cell called a lymphocyte. Because of a characteristic chromosomal abnormality in the cancer cells in NHL, as few as 1 malignant lymphocyte in 100,000 normal cells can be detected in the blood using a sensitive molecular test method known as polymerase chain reaction (PCR). The absence of detectable cancer cells in the blood, based on this sensitive test, is referred to as molecular remission. The preponderance of published clinical studies using a variety of therapeutic regimens has demonstrated a strong relationship between molecular remission and the length of tumor-free survival.
Dr. Steve Arikian, Biovest Chairman and CEO commented:
"The FDA's encouragement to move forward with this revised end point and data analysis could allow Biovest to shorten the time it takes to show a difference between treatment and control arms in the ongoing pivotal Phase 3 study. This may allow us to apply for approval of BiovaxID significantly earlier than might otherwise be possible."
Dr. Arikian continued:
"In its Phase 2 trial, BiovaxID successfully induced molecular remission in approximately 70% of the evaluable treated patients - meaning that cancer cells could not be detected in the patient's blood using the most sensitive molecular screening techniques available. Using this same approach in our Phase 3 trial may put us in a position to have an approved indication for BiovaxID substantially earlier than would be possible using traditional clinical endpoints. This means that a potentially life-saving cancer therapy could become available to patients much sooner than would otherwise be the case."
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 - News) 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.
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 AutovaxID, BiovaxID 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.
Contact:
Biovest International, Inc., Worcester
Carl M. Cohen, Ph.D., 508-793-0001, x 448
ccohen@biovest.com
or
The Investor Relations Group, New York
Investors:
Jordan Silverstein, 212-825-3210
jsilverstein@investorrelationsgroup.com
or
Public Relations:
Lynn Granito, 212-825-3210
lgranito@investorrelationsgroup.com
Source: Biovest International, Inc.
