US Patents Complement Existing Patent Protection in the US, Europe, Japan, and China
CAMBRIDGE, MA, January 05, 2022 / B3C newswire / -- Thrombolytic Science, LLC (TSI) has been granted a second patent by the USPTO. The patent was granted for a novel treatment applicable to ischemic stroke, one of the leading causes of morbidity and mortality. Thrombolysis, the biological system responsible for dissolving blood clots, is the fastest, simplest, and most economical way to remove an obstructive clot and reestablish blood flow. The natural system uses both fibrinolytic enzymes, tissue plasminogen activator, tPA, and urokinase plasminogen activator, uPA. TSI’s method is based on an improved understanding of the of the natural biological system, which it mimics to make therapeutic thrombolysis more effective and safer.
According to Prof. Victor Gurewich, MD, Co-founder and Scientific Director of TSI, “the current and longstanding treatment for stroke has used tPA alone, which was a mistake since it is neither sufficiently effective nor safe, and fails to recognize that both activators are needed. Because of the complementary modes of action of the activators, their combination has a synergistic and more potent effect, so that smaller doses can be used thereby significantly reducing the bleeding risk. In our newly patented treatment, which utilizes the sequential combination of tPA and uPA, we have for the very first time an effective and safe treatment for ischemic stroke.”
“This additional patent in the United States continues to validate TSI’s innovative science while enabling us to further our partnering efforts to bring TSI’s therapeutic solution to patients,” said Alexis C. Wallace, MScEng, MBA, TSI co-founder and CEO.
Most strokes and heart attacks are caused by an occlusive intravascular clot. Since neither the brain nor heart can survive long without a flow of oxygenated blood, reperfusion must be as rapid as possible, for which fibrinolysis is well-suited, as it can be administered without delay. By contrast, however, the use of surgical device-based solutions is complicated and time-consuming since it requires hospitalization.
The standard fibrinolytic treatment uses a tPA dose of 75-90 mg alone in a 60-minute infusion, which carries a significant bleeding risk, and is not very effective. The study of the biological thrombolysis has shown that its mechanism uses both tPA and uPA in a sequential combination. Replicating this effect, TSI’s therapy requires only a safer 5 mg tPA bolus injection followed by a low dose prouPA infusion and is expected to show improved safety and efficacy in on-going clinical trials.
About Thrombolytic Science (TSI)
Thrombolytic Science, LLC is a privately held cardiovascular health company for improving the treatment of ischemic stroke and heart attacks. TSI's dual, sequential thrombolytic regimen was established by research in the laboratory of Victor Gurewich, MD, Professor of Medicine, Harvard Medical School.
TSI clinical development includes an ongoing Phase II multicenter clinical trial in ischemic stroke patients, comparing TSI’s treatment with that of standard of care, conducted by the neurology department at Erasmus MC, in Rotterdam, NL. To date, the Phase II trial has enrolled 172 out of 200 ischemic stroke patients. A Phase I clinical trial was successfully completed in 2017 at the Center for Human Drug Research in Leiden, NL. TSI anticipates that this same treatment will also be tested in patients with heart attack in the UK.
Keywords: Humans; Blood Coagulation; Stroke; Ischemic Stroke; Myocardial Infarction; Brain Ischemia; Tissue Plasminogen Activator; Urokinase-Type Plasminogen Activator; prourokinase; Thrombosis; Arteries; Fibrinolysis; Solubility; Thrombolytic Therapy; Fibrinolytic Agents; PLAT protein, human; Standard of Care; Stroke; Fibrin Clot Lysis Time; saruplase; Brain; Biotechnology; Pharmaceutical Preparations; Europe; Japan; China; North America
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