REHOVOT, Israel, December 18, 2014 /PRNewswire/ --
D-Pharm Ltd. (TASE: DPRM) reported today, December 18th, 2014, that its Phase 2 clinical study of THR-18 successfully achieved its primary endpoint in acute ischemic stroke (AIS) patients treated with tissue plasminogen activator (tPA). THR-18 demonstrated statistically significant reductions in the incidence of intracranial hemorrhage (ICH), brain swelling (edema) and a satisfactory safety profile. Moreover, stroke recovery was improved 2-fold in patients receiving THR-18, as judged by clinical outcome measures, 30 days following stroke.
THR-18 is a novel drug-candidate designed to neutralize or reduce the life-threatening adverse effects of thrombolytic therapy with tPA. This double-blind, placebo-controlled, escalating single-dose, Phase 2 study was the first to assess the safety, pharmacodynamics and pharmacokinetics of THR-18 and tPA in AIS patients.
The study has successfully defined the maximal tolerated and safe dose of THR-18 in AIS patients. The imaging data as assessed by CT (computed tomography) on day 2 following stroke and tPA treatment indicate that, in contrast to the placebo group, no patients treated with THR-18 had an intracranial hemorrhage, (p=0.02). Similarly, 0.54 mg/kg of THR-18 reduced by more than twice the occurrence of brain edema (p<0.05).
The clinical outcome following stroke was assessed using the modified Rankin Scale (mRS) and the NIH stroke scale (NIHSS); the former reflecting disability in terms of daily living and the latter neurological deficit. The efficacy data analysis indicates that 0.54 mg/kg of THR-18 doubles the recovery rate assessed both with mRS and NIHSS scales.
Dr. Gilad Rosenberg, D-Pharm's VP of Clinical Development commented, "It is very gratifying see that the reduced rates of brain swelling - an adverse phenomenon likely enhanced by tPA's neurotoxic effects - do translate into less disability and better neurological recovery in tPA-treated stroke patients receiving THR-18."
D-Pharm's CEO, Dr. Alex Kozak added, "These results are the first most encouraging indication of THR-18's potential to make thrombolytic therapy safe and ultimately available to a majority of stroke patients. Now we can move decisively into development of THR-18 to confirm the Phase 2a data in a large-scale clinical study."
tPA is the only FDA approved therapy for treatment of acute stroke patients. Despite this, tPA is underused; it is estimated that less than 5% of patients receive this treatment primarily because of the 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 uncouples the clot-dissolving properties of tPA from its deleterious non-fibrinolytic effects on the blood vessel wall, including intracranial hemorrhage and brain edema, and leaves tPA's catalytic activity intact.
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 three clinical stage (phase 2) products, i.e., THR-18 for thrombolysis, DP-b99 for acute pancreatitis, and DP-VPA for epilepsy, as well as a preclinical development pipeline for misfolded protein disorders such as Alzheimer's disease, and other types of dementia. D-Pharm is currently exploring possibilities to support its development programs with substantial capital increase, privately and publically.
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:
Email: [email protected]
SOURCE D-Pharm Ltd