Thrombolytic Science, LLC (TSI) today announced initiation of a Phase 2 clinical trial to confirm the efficacy and safety of its sequential dual-treatment regimen of low-dose tissue plasminogen activator (tPA) and HisproUK (TSI’s mutant prourokinase [proUK]) in patients who have experienced ischemic stroke.
The study follows a recently completed Phase 1 study that confirmed the safety and tolerability of TSI’s regimen in healthy volunteers (n=26).
The Phase 2 study will be led by Prof. Diederik Dippel, MD, PhD, co-director of the Erasmus MC Stroke Center in Rotterdam, The Netherlands, and will compare the TSI regimen against high-dose tPA monotherapy – the current standard of care – following an ischemic stroke in patients with distal blood clots (i.e., those not retrievable with a surgical device). TSI also plans to initiate a Phase 2 study of a pre-hospital dual-treatment regimen in heart attack patients, in 2019, for which the company is currently fund raising.
“Initiation of our Phase 2 trial in ischemic stroke is an important milestone for TSI, the medical community, and patients, as we take a step closer to possibly treating ischemic stroke faster, safely, and with greater confidence,” said Alexis Wallace, MScENG, MBA, TSI co-founder and CEO. “Having been greatly encouraged by the favorable results from our Phase 1 trial of low-dose tPA and HisproUK, we are confident that the Phase 2 study will further characterize the clinical utility of this next-generation clot-dissolving regimen. We look forward to exploring potential partnerships with pharmaceutical companies as we continue to advance the clinical development program for this promising dual-therapy.”
TSI’s flagship product, HisproUK, is a more stable and safer version of proUK. Created by recombinant technology, HisproUK is designed to modulate the high intrinsic activity of proUK, which led to bleeding in previous studies. TSI’s sequential dual-therapy regimen starts with low-dose tPA, which initiates the natural process of thrombolysis. Low dose tPA activates plasminogen into plasmin, which degrades the surface of the clot. HisproUK then activates two additional plasminogen binding sites on the degraded clot surface, a step that accelerates thrombolysis. Together, these natural and synergistic mechanisms enable the process of clot dissolution at low doses.
“Timely and rapid clot dissolution is key to treating ischemic stroke, especially when the clots are distal, a situation that asks for medical treatment with a next generation thrombolytic drug to minimize complications and maximize chances of good outcome,“ explained Prof. Dippel. “That makes this Phase 2 trial particularly important, as we hope to show that sequential dual-therapy with low-dose tPA and HisproUK can initiate thrombolysis safely and effectively.”
The vast majority (roughly 85%) of stroke cases are ischemic, meaning they are caused by an obstruction within a vessel supplying blood to the brain. Stroke claims a life every 10 seconds, and kills more people each year than AIDS, tuberculosis and malaria combined. In the U.S., 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. Currently, there is no effective or safe treatment to dissolve blood clots, a factor that contributes to the low percentages of patients in the U.S. (<5%) and Europe (<10%) who are treated for stroke.
About Thrombolytic Science
Thrombolytic Science, LLC (TSI) is a privately-held vascular health and biotechnology company leading development of a next-generation, life-saving therapy to transform traditional medical approaches for treating blood clots caused by ischemic stroke and heart attacks – interventions that have not changed in decades. The company’s vision is to bring clot-busting therapy directly to the patient quickly, especially following an ischemic stroke, rather than having a patient wait to get to a hospital. TSI's dual, sequential thrombolytic regimen was established based upon research at Tufts University School of Medicine and Harvard Medical School, where scientists designed HisproUK.