News | Antiplatelet and Anticoagulation Therapies | September 07, 2018

Thrombolytic Science Initiates Phase 2 Trial of Novel Ischemic Stroke Treatment Regimen

Study seeks to confirm efficacy and safety of next-generation clot-dissolving therapy consisting of low-dose tPA and HisproUK

Thrombolytic Science Initiates Phase 2 Trial of Novel Ischemic Stroke Treatment Regimen

September 7, 2018 — A new Phase 2 clinical trial looks to confirm the efficacy and safety of Thrombolytic Science LLC’s (TSI) sequential dual-treatment regimen of low-dose tissue plasminogen activator (tPA) and HisproUK (TSI’s mutant prourokinase [proUK]) in ischemic stroke patients. 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, M.D., Ph.D., co-director of the Erasmus MC Stroke Center in Rotterdam, The Netherlands. It 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 raising funds.

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 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.”

For more information: www.tsillc.net

Related Content

Fragmin (dalteparin sodium) injection was cleared by the FDA for use in pediatric patients. It was initially approved by the FDA in 1994 for adults and is a type of heparin.

Fragmin (dalteparin sodium) injection is now cleared by the FDA for use in pediatric patients. It was initially approved by the FDA in 1994 for adults and is a type of heparin.

Technology | Antiplatelet and Anticoagulation Therapies | May 17, 2019
May 17, 2019 — The U.S.
PhaseBio Receives FDA Breakthrough Therapy Designation for Ticagrelor Reversal Agent
Technology | Antiplatelet and Anticoagulation Therapies | April 30, 2019
PhaseBio Pharmaceuticals Inc. announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy...
People With Heart Disease at Risk When Pharmacies Close
News | Antiplatelet and Anticoagulation Therapies | April 24, 2019
April 24, 2019 — New research from the University of Illinois at Chicago shows that when pharmacies close, people sto
Study Finds Only Six Percent of Patients Taking Statins as Directed
News | Antiplatelet and Anticoagulation Therapies | April 18, 2019
A recent study found patients with atherosclerotic cardiovascular disease cut their risk of a second major adverse...
HonorHealth Research Institute Launches SynIVUS-DAPT Study
News | Antiplatelet and Anticoagulation Therapies | April 16, 2019
HonorHealth Research Institute announced the first patients have been enrolled in the SynIVUS-DAPT Study. The clinical...
Lack of Physician Guidance, Fear of Side Effects Influence Statin Compliance
News | Antiplatelet and Anticoagulation Therapies | April 15, 2019
Despite national guidelines indicating statins can lower risk of heart attack and stroke, many patients who could...
Stopping DAPT After One Month Improved Outcomes in Stent Patients
News | Antiplatelet and Anticoagulation Therapies | March 25, 2019
Patients who stopped taking aspirin one month after receiving a stent in the heart’s arteries but continued taking the...
Apixaban Effective in Specific Cohort of Non-Valvular Atrial Fibrillation Patients
News | Antiplatelet and Anticoagulation Therapies | March 19, 2019
The Bristol-Myers Squibb-Pfizer Alliance announced results from the Phase 4 AUGUSTUS trial evaluating Eliquis (apixaban...
Researchers Develop Reversible, Drug-Free Antiplatelet Therapy
News | Antiplatelet and Anticoagulation Therapies | February 19, 2019
A new reversible, drug-free antiplatelet therapy could reduce the risk of blood clots and potentially prevent cancer...
FDA Approves Portola Pharmaceuticals' Prior Approval Supplement for Andexxa Generation 2 Manufacturing Process
News | Antiplatelet and Anticoagulation Therapies | January 02, 2019
The U.S. Food and Drug Administration (FDA) has approved Portola Pharmaceuticals’ Prior Approval Supplement (PAS) for...
Overlay Init