Tuesday, Feb 21, 1984
South San Francisco, Calif. -- February 21, 1984 --Genentech, Inc. announced today that it has begun the first clinical testing of human tissue-type plasminogen activator (t-PA) produced by recombinant DNA technology.
Human evaluations began mid-February on the use of recombinant t-PA in dissolving blood clots in the coronary arteries of patients suffering a myocardial infarction (heart attack). The first patient was treated by Johns Hopkins cardiologist at Baltimore City Hospitals. Patients have also been treated by cardiologists at Johns Hopkins Hospital in Baltimore, Massachusetts General Hospital in Boston and Washington University in St. Louis.
Testing of recombinant t-PA for treatment of peripheral arterial occlusion (blood clots in the arms and legs) will begin shortly at The Cleveland Clinic in Cleveland.
Cardiovascular disease is the leading cause of death in the United States. A heart attack or other life-threatening condition can result when a blood clot suddenly obstructs blood flow through a vessel, such as a coronary artery. There is great need for a potent, specific and easily administered blood-clot-dissolving agent that could potentially save lives and reduce the damage caused by clots.
T-PA is a natural protein found in minute quantities in the body?s circulatory system. It activates the body?s blood-clot-dissolving system at the site of a blood clot and thereby breaks down the clot. Through the use of recombinant DNA technology, t-PA can now be manufactured in sufficient quantity to clinically evaluate its use in the treatment of coronary disease.
Results to date are encouraging. Laboratory and animal studies indicate that Genentech?s t-PA is a potent, specific, clot-dissolving agent that could be safer, more effective and more easily administered than current therapy in breaking down blood clots and restoring blood flow. Clinical evaluations will determine the product?s safety and effectiveness as a medical treatment.
Genentech, Inc. is a leader in the development, manufacture and marketing of recombinant DNA products, principally for human and animal health care. Recombinant t-PA will be manufactured and marketed by Genentech in the U.S. under its own label, in conjunction with Genentech Clinical Partners II, a limited partnership. Contract partners will market the product outside the U.S.
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