Biotechnology company Thrombolytic Science LLC (TSI) said on Monday that it has completed its Phase 1 clinical trial of a new-generation clot-dissolving therapy TS01 for the treatment of clot-induced diseases.
The company said 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.
According to the company, this first-in-man randomised, double-blind, placebo-controlled study demonstrated the overall safety and tolerability of TS01 in healthy adults.
This 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.
In conjunction, 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.
Each year, strokes affect 15 million people worldwide. Approximately 90% of all strokes are caused by blood clots, for which there is no effective and safe treatment.
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