COPIAGUE, N.Y., April 6, 1999 -- American Biogenetic Sciences,
Inc. (ABS) (Nasdaq: MABXA) announced today that it has completed development of its rapid point of care version of its proprietary Thrombus Precursor Protein (TpP?) test to detect blood clot formation. Now that development has been completed, the Company will initiate clinical trials with the product. The objective of these clinical trials will be to verify in the clinical setting that the point of care device is effective in both identifying and ruling out the presence of life-threatening blood clots in conditions such as myocardial infarction (MI), deep vein thrombosis (DVT) and pulmonary embolism (PE). The clinical testing is an essential step prior to submission to the U.S. Food and Drug Administration for marketing clearance.
The clinical evaluation of the TpP point of care test will be conducted under the supervision of hematologist Dr. Yale Arkel, Director of the Blood Disorders Center at Overlook Hospital in Summit, New Jersey. Dr. Arkel is a highly respected clinician and investigator in hematology. He was one of the founders and first president of the North American Specialized Coagulation Laboratories Association, and is a long standing member of the American Society of Hematology and the International Society on Thrombosis and Hemostasis. In addition to his duties at the Overlook Hospital, Dr Arkel is an Associate Professor of Clinical Medicine at the College of Physicians and Surgeons of Columbia University in New York.
John S. North, President and CEO of ABS emphasized that the development of the point of care TpP device could be a key milestone for the Company. “This is a critical phase in our quest to provide healthcare professionals with a tool that promises to improve the diagnosis of blood clots, and thereby enhance treatment,” said Mr. North. “The laboratory version of TpP is already FDA approved and has demonstrated the ability to provide doctors with clinical knowledge on whether a clot is forming. The point of care device is expected to offer that information immediately in a variety of settings at a fraction of the time standard diagnostics require.”
Dr. Arkel, who has acted as principal investigator on a number of TpP clinical trials, said that the availability of a point of care test for blood clots could be highly beneficial. “Blood clots are the number one cause of death in the industrialized world,” said Dr. Arkel. “If a patient is developing a life-threatening clot, doctors need to know that, and know it fast. Rapid and accurate identification of clot formation will allow doctors to move more quickly in treating these conditions. Conversely, more than five million Americans present at emergency rooms each year with chest pain, while only 15 per cent are in fact having a heart attack. The ability to differentiate between patients experiencing a heart attack and those who are not, can have major healthcare and economic consequences.”
“The availability of a point of care format would vastly increase the commercial potential of the TpP test,” added Mr. North. “When you consider the full range of possible applications of this diagnostic, including ruling out deep vein thrombosis, pulmonary embolism, and heart attack you arrive at a figure of more than 400 million potential TpP tests per year. That could rapidly translate into substantial annual revenues, especially with the help of a major pharmaceutical company as a partner.”
American Biogenetic Sciences, based in Copiague, New York, researches and develops diagnostic tests for cardiac conditions and infectious diseases, as well as new treatments for neurological disorders including epilepsy, migraine, mania, Parkinson's and Alzheimer's disease. ABS also seeks out new technologies and conducts research and development throughout its Global Scientific Network, in the U.S., Europe, Israel, Russia and China.
Statements in this release that are not strictly historical are “forward-looking” statements within the meaning of the Private Securities Litigation Reform Act of 1995, and should be considered as subject to various risks and uncertainties that could cause actual results to differ materially from those anticipated. For further details and a discussion of these risks and uncertainties, see the Company's Securities and Exchange Commission filings, including its annual report or Form 10-K.