TSI Completes Phase 1 Clinical Trial of Novel Clot-dissolving Therapy, TS01
- Category: Proteins and Peptides
- Published on Tuesday, 19 September 2017 09:00
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Novel Mechanism of Action Promotes Enhanced Safety and Efficacy for the Treatment of Stroke and Myocardial Infarction
CAMBRIDGE, MA, USA I September 18, 2017 I Thrombolytic Science, LLC (TSI), a clinical stage vascular health and biotechnology company, today announced the completion of a Phase 1 clinical trial of TS01, a new-generation clot-dissolving therapy aimed at the treatment of clot-induced diseases such as ischemic stroke and acute myocardial infarction or heart attack. This first-in-man randomized, double-blind, placebo-controlled study demonstrated the overall safety and tolerability of TS01 in healthy adults.
The human body's fibrinolytic, clot dissolving, system uses two natural enzymes, tissue plasminogen activator (tPA) and prourokinase (proUK), rather than only one of them.
"The two enzymes have complementary functions and are both required for a full fibrinolytic effect," said Victor Gurewich, MD, Chief Scientific Officer of TSI. "Therefore, TS01 uses Nature's clot-dissolving design, in a safe, low-dose sequence of tPA and Hisprourokinase (HisproUK), a proprietary and safer version of proUK, with the same function as its parent molecule."
The Phase 1 study was conducted at the Centre for Human Drug Research in Leiden, The Netherlands. In this dose-escalation trial, 26 healthy males were given a single dose of HisproUK or a sequential administration of a very low dose of tPA followed by an infusion of HisproUK. No coagulation changes, indicative of safety, occurred.
"Current treatment options for stroke patients are extremely limited," said Alexis C. Wallace, Chief Executive Officer of TSI. "and because TS01 induces rapid clot dissolution using significantly smaller, safer doses than is possible with monotherapy - the current standard method of treatment, we expect TS01's enhanced safety and efficacy to fundamentally alter the treatment paradigm for patients with acute ischemic stroke, TS01's first indication."
Each year, strokes affect 15 million people worldwide. In the United States, it is the leading cause of long-term disability and the fifth-leading cause of death, costing the healthcare system in excess of $73 billion each year. Approximately 90 percent of all strokes are caused by blood clots, for which there is no effective and safe treatment.
TS01 is a proprietary new-generation, clot-dissolving therapy for the treatment of patients with ischemic stroke and other thrombotic diseases. HisproUK, TS01's main component, is a proprietary, rationally designed, single-site mutant of native proUK. TS01 selectively targets occlusive clots that cause strokes and heart attacks.
TSI is a privately-held vascular health and biotechnology company currently developing a new-generation bio-inspired clot-dissolving therapy. TSI intends to develop treatments for ischemic stroke, heart attacks and other thrombotic diseases. TSI's technology is based upon pioneering earlier work on proUK by the Vascular Research Laboratory.
SOURCE: Thrombolytic Science