Israel-based D-Pharm has received approval from the regulatory authorities in the Ukraine to start a Phase IIa clinical trial of THR-18, a synthetic therapeutic peptide derived from plasminogen activator inhibitor-1 (PAI-1).
THR-18 is indicated to be given with the clot buster drug tissue plasminogen activator (tPA) in patients with acute ischemic stroke.
In the double-blind, placebo-controlled, escalating single-dose Phase IIa study, the company will evaluate the safety, pharmacokinetics and pharmacodynamics of THR-18 given with tPA to acute ischemic stroke patients.
Under the trial, 30 patients will be divided into three escalating dose groups, each group with an active and placebo arm.
The Phase IIa trial, which will be carried out at a single site in Kharkov, Ukraine, is scheduled to start on 22 October.
According to the company, THR-18 has completed a Phase I clinical study in healthy volunteers.
Tissue plasminogen activator, which is approved for treatment of myocardial infarction, pulmonary embolism, is claimed to be the only US Food and Drug Administration (FDA) and European Medicines Agency (EMA) approved drug for treatment of acute ischemic stroke.
The company said that, 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).
D-Pharm VP for Clinical Development Gilad Rosenberg said THR-18 is designed to neutralise the harmful effects of tPA, significantly increasing the patient population eligible for thrombolytic therapy.
"We’ve ensured that precious minutes to treatment will not be lost, by developing a new THR-18 formulation suitable for easy preparation and co-administration with tPA," Rosenberg said.
"This study, in thirty patients, will provide crucial information regarding safe doses of THR-18 that may be administered in this critically ill population."
If approved, 90% of patients treated with tPA will likely receive treatment with THR-18, according to the results from a survey of neurologists and payors.
D-Pharm assumed responsibility for THR-18 development in 2012 following its acquisition of clinical stage company Thrombotech.
The company believes that more patients can benefit from THR-18 as it improves the safety and efficacy of the currently available treatment for ischemic stroke patients by significantly decreasing the life-threatening side effects.
Image: CT-scan of the brain with an middle cerebral artery infarct. Photo: courtesy of Sreejithk2000.