D-Pharm Ltd. Completes Recruitment Of Patients Into The First Dosage Tier Of Its Phase 2 Study With THR-18 In Acute Stroke Patients Treated With tPA.
1/21/2014 10:43:10 AM
January 21, 2014 -- 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 (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.
For further information please contact:
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.
Help employers find you! Check out all the jobs and post your resume.
comments powered by