D-Pharm Commences Phase 2 Study with THR-18 In Stroke Patients Treated with Tissue Plasminogen Activator

18-Oct-2013 - Israel

D-Pharm Ltd announced receipt of approval from the regulatory authorities in the Ukraine to commence a Phase IIa clinical study of THR-18, to be given with the clot buster drug tissue plasminogen activator (tPA), in patients with acute ischemic stroke. THR-18 is a synthetic therapeutic peptide derived from plasminogen activator inhibitor-1 (PAI-1).

This is a double-blind, placebo-controlled, escalating single-dose, Phase IIa study to assess, for the first time, the safety, pharmacokinetics and pharmacodynamics of THR-18 given with tPA to patients with acute ischemic stroke. The study will enroll 30 patients divided into three escalating dose groups, each group with an active and placebo arm. The study will be performed at a single site in Kharkov, Ukraine. The site initiation is scheduled for 22nd October, 2013. THR-18 has successfully completed a Phase 1 clinical study in healthy volunteers.

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