TSI Completes Phase 1 Clinical Trial of Novel Clot-dissolving Therapy, TS01

Thrombolytic Science, LLC (TSI) 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.”