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Thrombolytic Science Receives FDA Clearance for mproUK Clinical Trial

• Thrombolytic Science (TSI) has received FDA clearance for its Investigational New Drug application for mproUK, a recombinant fibrinolytic pro-enzyme, confirming its safety profile. • The Phase II trial in the UK for myocardial infarction is set to commence following MHRA approval, building on promising Phase II results from the DUMAS trial in stroke patients in the Netherlands. • mproUK offers a potentially safer and more effective reperfusion option for life-threatening thrombotic conditions, with the possibility of earlier blood flow re-establishment. • The treatment approach combines a mini bolus of r-tPA followed by a low dose of mproUK, showing promise in clinical studies with reduced bleeding risk and rethrombosis.

Thrombolytic Science (TSI) has secured FDA clearance for its Investigational New Drug (IND) application for mutant prourokinase (mproUK), a recombinant fibrinolytic pro-enzyme. This clearance paves the way for U.S. clinical trials and reaffirms the safety and tolerability of mproUK, offering a potentially transformative approach to treating life-threatening thrombotic conditions.

Advancing Fibrinolytic Therapy

Alexis C. Wallace, CEO of TSI, stated, "Our innovative approach to fibrinolytic therapy has the potential to transform the treatment landscape for life-threatening thrombotic conditions, offering patients a faster, safer, and more effective reperfusion option." The company is building on promising Phase II results from the DUMAS trial, which studied stroke patients in the Netherlands. Following MHRA approval, a Phase II trial in the UK focusing on myocardial infarction is planned. This IND clearance marks a significant step toward broader global access to TSI's low-dose fibrinolytic treatment.

Physiological Mechanism and Clinical Potential

The physiological mechanism of clot lysis involves tissue plasminogen activator (tPA) initiating clot lysis, while prourokinase completes the dissolution of the fibrin clot. According to Dr. Victor Gurewich, Co-Founder and Discoverer of Prourokinase at TSI, "tPA is like the starter, whereas prourokinase is the engine. Physiological fibrinolysis requires a mini bolus of r-tPA followed by an infusion of a low dose of mproUK." Recent clinical studies suggest this treatment approach is free of bleeding risk and rethrombosis, potentially re-establishing blood flow earlier and proving more cost-effective than in-hospital surgical solutions.
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Reference News

[1]
Thrombolytic Science Receives FDA Investigational New Drug Clearance
pharmaceuticalmanufacturer.media · Sep 26, 2024

Thrombolytic Science (TSI) received FDA approval for its Investigational New Drug application for mproUK, a recombinant ...

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