Policy & Regulation
Pharmazz Inc begins Phase III trial of PMZ-1620 in cerebral ischemic stroke patients
19 July 2019 -

Critical care medicine company Pharmazz Inc said on Thursday that it has received clearance to launch a prospective, multicentric, randomized, double-blind, parallel, phase III clinical study to assess efficacy of PMZ-1620 in patients of acute ischemic stroke in India.

PMZ-1620 (IRL-1620; INN sovateltide) is a highly selective endothelin-B receptor agonist that has been found to be safe in human phase I and II trials.

Under the company's prospective, multi-centric, randomized, double-blind, parallel, saline controlled phase II study in 40 patients with cerebral ischemic stroke, all patients received standard treatment and were assigned to either control or PMZ-1620 cohort and received saline or PMZ-1620 within 24 hours of onset of stroke.

A rapid improvement in clinical outcome was observed in patients treated with PMZ-1620. The treatment did not have any effect on hemodynamic, biochemical or hematological parameters. PMZ-1620 has the potential to be a first-in-class neuronal progenitor cell therapeutics with anti-apoptotic activity that improves cerebral blood flow and neurological outcome in cerebral ischemic stroke patients, according to the company.

In conjunction, the company announced publication of a key article titled "Anti-apoptotic activity of ETB receptor agonist, IRL-1620, protects neural cells in rats with cerebral ischemia" in Scientific Reports. Full-text access to paper is at the following link: https://rdcu.be/bKOYh.

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