D-Pharm Reports the Successful Interim Analysis of its Phase 2 Clinical Study of THR-18 in Acute Stroke Patients Treated With the Thrombolytic Drug tPA
REHOVOT, Israel, March 4, 2014 /PRNewswire/ --
D-Pharm Ltd (TASE: DPRM) announced today, March 4th, 2014, the successful interim analysis of the first group of stroke patients that completed follow-up in the Phase 2 clinical study of THR-18. The interim report confirms the safety and tolerability of THR-18 at a dose of 0.18mg/kg, administered together with tissue plasminogen activator (tPA) in acute ischemic stroke patients. The interim report gives a green light to proceed to recruit the second group of patients for treatment with THR-18 at a higher dose level.
THR-18 is novel drug-candidate designed to reduce or neutralize the life-threatening adverse effects of tPA, such as intracranial hemorrhage (ICH) and brain edema. The current study is the first double-blind, placebo-controlled, escalating single-dose, Phase 2a study to assess the safety, pharmacokinetics, and pharmacodynamics of THR-18 in acute ischemic stroke patients treated with tPA.
Dr. Gilad Rosenberg, D-Pharm's VP for Clinical Development commented, "It is reassuring to see that safety and tolerability of the first dose of THR-18 has been confirmed. It enables us to move forward and test the higher dose of 0.54 mg/kg in stroke patients treated with tPA."
THR-18 corresponds to a fragment of plasminogen activator inhibitor-1 (PAI-1), a natural inhibitor of tPA activity. THR-18 binds at one of the PAI-1 docking sites on tPA that leaves tPA's catalytic activity intact. THR-18 binding uncouples the clot-dissolving properties of tPA from its deleterious non-fibrinolytic effects on the blood vessel wall, including intracranial hemorrhage and brain edema.
D-Pharm (http://www.dpharm.com) is a clinical stage, technology-driven biopharmaceutical company developing proprietary products for treatment of CNS disorders. D-Pharm's pipeline includes clinical stage II products, as well as a rich preclinical development pipeline for Alzheimer's disease, and other types of dementia. D-Pharm is currently enrolling acute severe pancreatitis patients to test DP-b99 in another Phase 2 clinical study.
Statements in this press release that are not historical facts are forward-looking information, as defined in the Securities Law, based on information available to D-Pharm at the time of this press release. The estimations could, some or all, be unrealized, or could be realized in significantly different ways than expected.
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SOURCE D-Pharm Ltd