THR-18 significantly decreases the occurrence of intracranial hemorrhage and brain edema, and enhances recovery in acute ischemic stroke patients
REHOVOT, Israel I December 18, 2014 I 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
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
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.
About D-Pharm
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.
SOURCE: D-Pharm
Post Views: 31
THR-18 significantly decreases the occurrence of intracranial hemorrhage and brain edema, and enhances recovery in acute ischemic stroke patients
REHOVOT, Israel I December 18, 2014 I 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
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
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.
About D-Pharm
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.
SOURCE: D-Pharm
Post Views: 31
