WEST BRIDGEWATER, Mass., Oct. 11 /PRNewswire/ -- Boston Biomedica, Inc. (Nasdaq: BBII) announced today that BBI Biotech Research Laboratories, its research and development facility in Gaithersburg, MD, has been awarded a subcontract by New England Research Institutes, Inc. (NERI) to provide repository and related services for the Hepatitis C Antiviral Long-term Treatment against Cirrhosis (HALT-C) Trial, a clinical trial funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), an institute of the National Institutes of Health (NIH). The award for the first year is $854,000. Subsequent continuations and modifications are at the discretion of NERI, but BBI currently anticipates similar annual funding levels to April 2004, with reduced funding through April 2007 for storage only. This subcontract is part of an eight year, $28 million contract awarded to NERI, the clinical sites and a virology laboratory by NIDDK to conduct a clinical trial of antiviral drug treatment for chronic Hepatitis C, the largest and longest study of Hepatitis C conducted to date. This carefully controlled trial, conducted at ten clinical sites throughout the country, will study 1,300 patients with chronic Hepatitis C, and is designed to evaluate the effectiveness of long-term antiviral therapy in preventing cirrhosis and liver failure.
Under the terms of the subcontract BBI Biotech will serve as the central repository for the HALT-C Trial. In coordination with NERI, BBI Biotech will manage biological specimen collection, storage and shipping, and will develop and maintain a computerized system to track samples. In addition, BBI will perform alpha-fetoprotein analysis and sophisticated procedures to immortalize cells, providing a reproducible source of DNA for continuing studies of disease progression.
"We are very pleased to have been selected for this work by NERI," commented Dr. Mark Cosentino, Director of Cell Biology at BBI Biotech. "BBI Biotech's expertise in handling and processing infectious material, our strong cell biology experience and expertise, and our reputation in repository management make us ideally suited to supply the necessary support services for this study. Being involved in this clinical trial allows BBI Biotech to blend its strength as a quality provider of various cellular and testing services with its expertise in repository management."
The HALT-C Trial provides a unique opportunity to study the pathogenesis of Hepatitis C and the changes associated with therapy, and to collect and store specimens prospectively from patients who will be undergoing long-term antiviral therapy. Hepatitis C, which is spread primarily by contact with blood and blood products, is found throughout the world and accounts for a substantial proportion of the cases of chronic liver disease. Nearly four million Americans are infected with Hepatitis C, leading to 10,000 deaths and approximately 1,000 liver transplants annually in the US.
"This repository of serum, plasma, liver tissue and lymphocytes collected for the HALT-C Clinical Trial will provide a unique resource for studies on the long-term effects of antiviral therapy on disease pathogenesis," said Elizabeth Wright, Principal Investigator of the NERI Contract and Senior Research Scientist at NERI. "We feel confident that the expertise in repository operations and the extensive state-of-the-art storage facilities brought to this project by BBI will ensure proper preservation of and access to these materials for the current and subsequent studies."
Boston Biomedica, Inc. provides products and services for the detection and treatment of infectious diseases such as AIDS, Lyme Disease, and Viral Hepatitis. The Company has four business units: (1) BBI Diagnostics, an ISO 9001 certified manufacturer and supplier of quality control and diagnostics reagents used to increase the accuracy of in vitro diagnostic tests, (2) BBI Clinical Laboratories, a leading specialty infectious diseases testing laboratory, (3) BBI Biotech Research Laboratories, providing R&D support for the other BBI business units as well as contract research services for third parties, and (4) BBI Source Scientific, an ISO 9001 certified manufacturer of laboratory and diagnostic instrumentation. In addition, the Company is pursuing research and development programs in the areas of Pressure Cycling Technology (PCT) and drug discovery through its subsidiaries BBI BioSeq and Panacos Pharmaceuticals, respectively, with the goal of introducing new solutions for the detection, management and treatment of infectious diseases.
Statements contained in this news release that state the Company's or management's intentions, hopes, beliefs, expectations or predictions of the future are "forward-looking" statements. It is important to note that the Company's actual results could differ materially from those projected in such forward-looking statements. Factors that could cause actual results to differ from those projected include the possibility that BBI may not be awarded the NERI subcontract for subsequent years. Additional information concerning factors that could cause actual results to differ materially from those in the forward-looking statements is contained from time to time in the Company's SEC filing including, but not limited to, the Company's report on Form 10-K for the year ended December 31, 1999 and on Form 10-Q for the periods ended March 31 and June 30, 2000. Copies of these documents may be obtained by contacting the Company or the SEC.
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Richard T. Schumacher, CEO & Chairman Boston Biomedica, Inc.
Kevin W. Quinlan, President & COO (508) 580-1900 (T)
William R. Prather, M.D.,
Sr. VP Finance & Business Dvlp. (508) 580-1110 (F)
SOURCE Boston Biomedica, Inc.
Web site: http: //www.bbii.com
CONTACT: Richard T. Schumacher, CEO & Chairman, or Kevin W. Quinlan, President & COO, or William R. Prather, M.D., Sr. VP Finance & Business Dvlp., of Boston Biomedica, Inc., 508-580-1900