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FEB 26, 2020 6:00 AM PST

Keynote Presentation: Discovery and Development of a Novel First-in-Class Resuscitative Agent

C.E. Credits: P.A.C.E. CE Florida CE
Speaker
  • Chairman & Chief Executive Officer of Pharmazz, Inc.; Adjunct Professor, Colleges of Pharmacy and Graduate Studies, Midwestern University; Department of Bioengineering, University of Illinois
    Biography
      Anil Gulati, MD, PhD is Chairman and Chief Executive Officer of Pharmazz, Inc. and is an adjunct Professor at the Colleges of Pharmacy and Graduate Studies, Midwestern University and Department of Bioengineering at University of Illinois at Chicago, Illinois. He is a consultant to Advocate Lutheran General Children's Hospital. Dr. Gulati is the Scientific Reviewer, United States Defense Medical Research and Development Program, Combat Casualty Care Research Program 2016 and 2017. He is recipient of Outstanding Faculty Award 2017, Paul R Dawson Biotechnology Award 2014 and Littlejohn Award 2014. Dr. Gulati is a United States Fulbright Scholar 2008-2009 and winner of International Ranbaxy Research Award 2007. He has ~300 peer reviewed publications and guided researches of more than 100 graduate students, medical residents and research fellows. He has 5,446 citations, h-index of 41, i10-index of 147, research gate score of 46.58. He has 52 issued patents of which 24 has been issued by the US patent office, and rest by patent offices in Europe, India, China, Japan, Australia and Canada. Some of the discoveries related to endothelin made by him are undergoing clinical phase II trials in the United States and clinical phase III trials in India. Dr. Gulati founded Pharmazz, Inc. and its subsidiary Pharmazz India Private Limited which is developing his inventions for critical care medicine, resuscitation of shock, stroke and complication of diabetes. He was an elected Fellow of American College of Clinical Pharmacology and was Co-Chair of the ET-14: World Endothelin Conference 2015, Savannah, Georgia.

    Abstract

    Centhaquine (previously used names, centhaquin and PMZ-2010; International Non-proprietary Name (INN) recently approved by WHO is centhaquine) is being developed by us as a first-in-class resuscitative agent for treating hypovolemic shock. It acts on the venous α2B-adrenergic receptors and enhances venous return to the heart, in addition, it produces arterial dilatation by acting on central α2A-adrenergic receptors to reduce sympathetic activity and systemic vascular resistance. Enhanced cardiac output and blood flow to the vital organs, prevents organ failure and improves survival and recovery of hypovolemic shock patients. Toxicological studies showed high safety margin in preclinical studies. Its safety and tolerability have been demonstrated in a human phase I study in 25 subjects (NCT02408731). Phase II human studies showed extraordinary efficacy in patients with hypovolemic shock. A prospective, multi-centric, randomized, double-blind, parallel, saline controlled phase II study was carried out with centhaquine as a resuscitative agent for hypovolemic shock (NCT04056065). A total of 50 subjects met inclusion and exclusion criteria and were included in the study. Systolic and diastolic blood pressure in control group improved but in centhaquine group a much more significant increase in systolic and diastolic blood pressure was observed 48 hours after resuscitation. Blood lactate levels decreased from 4.30 ± 0.96 at baseline to 3.19 ± 1.07 (p=0.7729) at day 3 in control and from 4.34 ± 0.78 at baseline to 1.44 ± 0.13 (p=0.0012) at day 3 in centhaquine cohort. Two patients died in control and none in centhaquine cohort. No incidence of drug related adverse event occurred. A phase III multi-centric, randomized, double-blind, parallel, controlled phase-III efficacy clinical study of centhaquine therapy in patients with hypovolemic shock (NCT04045327) has been completed in 105 patients with positive results. Centhaquine is an innovative drug product that is likely to provide significant benefit to an unmet life-threatening medical condition of hypovolemic shock.


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