D-Pharm Ltd., a clinical stage, technology-driven biopharmaceutical
company developing proprietary products for treatment of CNS disorders,
has received the final report for its phase 2 clinical study of THR-18.
THR-18 demonstrated statistically significant reductions in the
incidence of intracranial hemorrhage (ICH), brain swelling (edema) and a
satisfactory safety profile in stroke patients treated with tPA.
Moreover, stroke recovery was improved 2-fold in patients receiving
THR-18, as judged by clinical outcome measures, 30 days following
stroke.
THR-18 is a novel drug-candidate designed to neutralize or reduce the life-threatening adverse effects of thrombolytic therapy with tPA. This double-blind, placebo-controlled, escalating single-dose, Phase 2 study was the first to assess the safety, pharmacodynamics and pharmacokinetics of THR-18 and tPA in AIS patients. The study results were presented last month at the European Stroke Organization conference in Glasgow.
The study successfully defined the maximal tolerated and safe dose of THR-18 in AIS patients. The imaging data as assessed by CT (computed tomography) on day 2 following stroke and tPA treatment indicate that, in contrast to the placebo group, no patients treated with THR-18 had an intracranial hemorrhage, (p=0.02). Similarly, 0.54 mg/kg of THR-18 reduced by more than twice the occurrence of brain edema (p<0.05).
THR-18 is a novel drug-candidate designed to neutralize or reduce the life-threatening adverse effects of thrombolytic therapy with tPA. This double-blind, placebo-controlled, escalating single-dose, Phase 2 study was the first to assess the safety, pharmacodynamics and pharmacokinetics of THR-18 and tPA in AIS patients. The study results were presented last month at the European Stroke Organization conference in Glasgow.
The study successfully defined the maximal tolerated and safe dose of THR-18 in AIS patients. The imaging data as assessed by CT (computed tomography) on day 2 following stroke and tPA treatment indicate that, in contrast to the placebo group, no patients treated with THR-18 had an intracranial hemorrhage, (p=0.02). Similarly, 0.54 mg/kg of THR-18 reduced by more than twice the occurrence of brain edema (p<0.05).
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