The randomized double-blind trial on 30 patients in three groups with increasingly higher dosages is being conducted at a medical center in Ukraine, and will be completed in the second half of 2014. The study's primary endpoint is to show that THR-18 is safe when taken in conjunction with tPA in cerebral stroke patients.
THR-18 is intended to decrease the risk of life threatening bleeding such as intra-cranial hemorrhage and brain edema in patients treated with the clot buster drug Alteplase (tPA). Alteplase, the only approved therapy for dissolution of blood clots in acute ischemic stroke, is also indicated for myocardial infarction and pulmonary embolism.
"Approval of the safety profile of the current dosage of THR-18 is encouraging. It allows us to move forwad to the higher dosage for cerebral stroke patients treated with tPA," said D-Pharm VP clinical development Dr. Gilad Rosenberg.
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