D-Pharm Begins Ukraine Stroke Trial

D-Pharm Ltd. has received approval from 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 trial to assess 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. THR-18 has successfully completed a Phase I clinical study in healthy volunteers.

Tissue plasminogen activator is approved for treatment of myocardial infarction, pulmonary embolism and it is the only drug approved by the FDA and EMA for treatment of acute ischemic stroke. However, in stroke, tPA is used, on average, in less than 5% of patients and within a narrow time window, due to the risk of life-threatening adverse effects, in particular, intra-cerebral hemorrhage (ICH). Results from a survey of neurologists and payors suggest that as many 90% of patients treated with tPA would also receive treatment with THR-18 (if approved). D-Pharm assumed responsibility for THR-18 development in 2012 when the company acquired the clinical stage company Thrombotech Ltd.