TSI finalizes Phase 2 Study Protocol in Myocardial infarction
Myocardial infarction (MI), commonly known as heart attack, occurs due to decrease in blood flow that damages heart muscles. Currently, MI treatment varies from making changes in lifestyle to medication and bypass surgeries. However, various pharmaceutical firms are making some groundbreaking advancements to develop novel clinical therapies for MI. Thrombolytic Science, LLC (TSI) is one such company that has made tremendous development in this field.
Recently, the company revealed that it has successfully made progress with 10 subjects registered in its randomized, prospective, multicenter Phase 2 clinical study, developed to confirm the efficacy and safety of sequential dual-treatment regimen of low-dose HisproUK and tPA (tissue plasminogen activator) in 200 patients that suffer from ischemic stroke.
Reportedly, the study is being led by Erasmus MC Stroke Center’s co-director, Prof. Diederik Dippel. In addition to this, TSI has also announced finalizing the protocol for a multicenter Phase 2 trial in 100 myocardial infarction patients and is expected to enroll its patients in Ukraine by Q1 of 2020.
Apparently, both MI and ischemic stroke are triggered by a blood clot. To regain adequate blood flow, the primary pharmacological treatment currently available consists of dissolving the clot, or thrombolysis, as fast as possible by infusing a dose of tPA, a single natural enzyme. However, studies indicate that natural thrombolysis is achieved by a sequence of tPA plus a second enzyme called proUK.
Speaking on the move, Alexis Wallace, MScEng, MBA, Co-founder and CEO, TSI, said that the company is on schedule with recruitment and initiation for both of its Phase 2 clinical studies that focus on comparing the TSI dual-therapy regimen against the standards regimen in each indication.
Wallace added that their firm has recorded inquiries from probable pharmaceutical partners and is expecting to further their discussions as it advances its clinical programs to improve the treatment of heart attacks and strokes.
Source Credit: https://www.b3cnewswire.com/201910301993/tsi-reports-enrollment-of-first-10-patients-in-its-phase-2-ischemic-stroke-clinical-trial-and-completion-of-its-phase-2-study-protocol-in-myocardial-infarction.html