D-Pharm Completes Recruitment of Patients into the first Dosage Tier of its Phase 2 Study with THR-18 in Acute Stroke Patients Treated with tPA
REHOVOT, Israel, January 21, 2014 /PRNewswire/ --
D-Pharm Ltd (TASE: DPRM) announced today, January 21st, 2014, that enrolment of patients into the first tier of its Phase 2 clinical trial with THR-18 in acute stroke patients is complete. The safety data for this dose tier will be assessed when follow-up for the 12th patient is complete, in about one month's time. This will be the first THR-18 safety assessment in stroke patients treated with tissue plasminogen activator (tPA) and, if satisfactory, it will enable D-Pharm to test THR-18 at a higher dose. THR-18 is designed to reduce the life-threatening adverse effects of tPA and improve its safety profile.
This 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. The study is enrolling 30 patients in total, divided into three escalating THR-18 dose groups, each group with an active and placebo arm. Once safety and tolerability of the first dose of 0.18mg/kg body weight is confirmed, the THR-18 dose will be escalated to the next dose of 0.54 mg/kg.
Dr. Gilad Rosenberg, D-Pharm's VP for Clinical Development commented, "I'm very pleased with the rapid enrolment, ahead of schedule, which reflects the dedication and efforts of the clinical investigators and the support team."
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 ICH and brain edema.
Recently, the Office of the Chief Scientist (OCS) of the Ministry of Economy approved an R&D budget of 3.6M NIS for THR-18 to support D-Pharm's development of THR-18. D-Pharm will continue to leverage its clinical development experience, particularly in stroke, to advance this product to market.
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. In addition to the Phase 2 study discussed above, D-Pharm started a second Phase 2 clinical program, for DP-b99 in acute severe pancreatitis, in November, 2013.
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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.
SOURCE D-Pharm Ltd