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D-Pharm Ltd. Reports Enrollment Of First Patient Into Phase 2 Study Of THR-18 In Stroke Patients Treated With Tissue Plasminogen Activator (tPA)
1/2/2014 9:03:53 AM
January 2, 2014 -- D-Pharm Ltd (TASE:DPRM) announced today, January 1st 2014, that the first patient has been enrolled into a Phase 2a clinical study of THR-18, a synthetic therapeutic peptide, in acute ischemic stroke patients being treated with tissue plasminogen activator (tPA). THR-18 is designed to neutralize the life-threatening adverse effects of tPA and improve its safety profile.
The study, at a single site in Kharkov, Ukraine, is enrolling 30 patients in total, divided into three escalating THR-18 dose groups of 0.18, 0.54, 0.90 mg/kg body weight; each group with an active and placebo arm. 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. THR-18 has successfully completed a Phase 1 clinical study in healthy volunteers.
D-Pharm’s VP for Clinical Development, Dr. Gilad Rosenberg added; “I’m happy to be involved in this clinical trial that may ultimately benefit stroke patients and I’m looking forward to swift patient enrolment. Treatment with the new formulation of THR-18 will facilitate its co-administration with tPA and provides a greater chance to improve patients’ recovery. I expect the results to provide some key safety and dosing information, needed to guide THR-18’s further development.”
Tissue plasminogen activator is approved for administration in acute ischemic stroke (AIS), as well as myocardial infarction and pulmonary embolism. In acute stroke patients, however, tPA is used in less than 5% of cases, since the majority is excluded from thrombolytic therapy due to the unacceptable risk of intra-cerebral hemorrhage (ICH), or failure to arrive within the narrow time window approved for treatment.
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, including ICH and brain edema.
D-Pharm’s CEO, Alex Kozak commented, “This is an important milestone for D-Pharm moving its drug candidates into the clinic for testing in the most devastating indications. THR-18 provides a unique opportunity to increase significantly the number of patients treated with tPA, the only approved therapy for acute stroke. Results from a survey of neurologists and payors suggest that, if approved, up to 90% of acute stroke patients treated with tPA would also receive treatment with THR-18. This product, therefore, has enormous potential to penetrate and expand the thrombolytic market.”
D-Pharm is committed to the development of THR-18, and will continue to leverage its clinical development experience, particularly in stroke, to advance this product to market.
D-Pharm Ltd. (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 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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