Results on Efficacy of PMZ-1620, an Endothelin-B Agonist, from Ongoing Phase II Trial in Patients with Cerebral Ischemic Stroke Presented at International Stroke Conference 2019
Feb 07, 2019, 07:00 ET
NAPERVILLE, Ill., Feb. 7, 2019 /PRNewswire/ -- Pharmazz, Inc., today announced that data from the Phase 2 clinical study in patients with acute cerebral ischemic stroke, were presented in the late breaking Multicenter, Ongoing Clinical Trials Posters II (Board CTP27) session at the International Stroke Conference 2019 in Honolulu, Hawaii February 6-8, 2019.
A prospective, multi-centric, randomized, double-blind, parallel, saline controlled phase II study is in progress with PMZ-1620 as an endothelin-B receptor agonist for cerebral ischemic stroke (CTRI/2017/11/010654). A total of 516 subjects were screened, of which 40 subjects met inclusion and exclusion criteria and were included in the study. All subjects received standard treatment for shock and were randomly assigned to either control cohort (N=20 of which 17 completed 30 and 10 completed 90 day study) that received standard treatment along with normal saline; or PMZ-1620 cohort (N=20 of which 17 completed 30 and 11 completed 90 day study) that received standard treatment along with PMZ-1620. PMZ-1620 administered intravenously was started within 24 hours after the onset of stroke and given till day 6. An improvement in Barthel Index of 50 or more was observed in significantly greater number of patients treated with PMZ-1620 compared to control (standard treatment). The odds ratio, between PMZ-1620 and control, at 30 day treatment was 2.571 (90% CI 0.7647 to 10.03) and at 90 day treatment was 6.75 (90% CI 1.158 to 25.25), indicating that PMZ-1620 is likely to be 575% better than control at 90 day treatment. Similarly, an improvement in modified Rankin Scale of 2 or more was observed in significantly greater number of patients treated with PMZ-1620 compared to control (standard treatment). The odds ratio, between PMZ-1620 and control, at 30 day treatment was 1.042 (90% CI 0.3170 to 3.311) and at 90 day treatment was 3.333 (90% CI 0.6660 to 13.01), indicating that PMZ-1620 is likely to be 233% better than control at 90 day treatment. PMZ-1620 treatment did not have any significant effect on systemic hemodynamics, biochemical or hematological parameters. No incidence of drug related adverse event. Patient enrollment has been completed and full data will be available mid-April this year and will be submitted for publication in a peer-reviewed medical journal.
PMZ-1620 could become the first-in-class therapy to treat cerebral ischemic stroke, through an endothelin (ETB receptor) based mechanism of action, of anti-apoptosis and stimulation of hidden stem cells to repair the damaged brain by formation of new neurons and blood vessels.
About Pharmazz, Inc.
Pharmazz, Inc. is a privately-held company engaged in the development of novel products in the area of critical care medicine. Additional information may be found on the Company's website, www.pharmazz.com.
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