D-Pharm Ltd. Reports The Successful Interim Analysis Of Its Phase 2 Clinical Study Of THR-18 In Acute Stroke Patients Treated With The Thrombolytic Drug tPA
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 (DPRM.TA) 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.
About D-Pharm
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.
Disclaimer
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.
For further information please contact:
Tami Horovitz
Tel: +972-8-9385100
Fax: +972-8-9300795
Email: thorovitz@dpharm.com
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