D-Pharm Reports Completion of the Second Dose Tier in its Phase 2 Clinical Study of THR-18 in Acute Stroke Patients Treated with the Thrombolytic Drug tPA
REHOVOT, Israel, June 2, 2014 /PRNewswire/ --
D-Pharm Ltd. (TASE: DPRM), Rehovot, Israel, reports today, June 2nd, 2014, the interim results for the second dose tier of stroke patients that completed follow-up in its Phase 2 clinical study of THR-18 and confirms the tolerability of THR-18 at a dose of 0.54 mg/kg, administered together with tissue plasminogen activator (tPA) in acute ischemic stroke (AIS) patients.
The primary goal of the current study is to identify the maximal tolerated and safe dose of the drug suitable for further clinical development. The current interim report indicates that the study may already have achieved this goal. To confirm this finding, the company has elected to recruit more patients at the same dose level and collect more data related to the effect of a high dose of THR-18 in AIS.
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. In this study, so far, patients treated with THR-18 have had fewer cases of ICH and edema compared to the placebo treated group. The groups are, however, too small to demonstrate statistical significance.
Dr. Gilad Rosenberg, D-Pharm's VP for Clinical Development commented, "We are continuing our efforts to define the highest THR-18 dose that may be safely administered to stroke patients. The data collected so far get us closer to this goal."
The Phase 2 clinical study of THR-18 is the first double-blind, placebo-controlled, escalating single-dose, study to assess the safety, pharmacokinetics, and pharmacodynamics of THR-18 in acute ischemic 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 2 products, as well as a rich preclinical development pipeline for Alzheimer's disease, and other types of dementia. In addition to the study discussed above, D-Pharm is currently recruiting patients with acute severe pancreatitis to test its cell protective drug, DP-b99, in a 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