Pharmazz, Inc.
Research and Development
Anil Gulati, MD, PhD is the Chairman and Chief Executive Officer at Pharmazz, Inc., Willowbrook, Illinois. He is Professor Emeritus at Midwestern University, the University of Illinois at Chicago, and is a consultant to Advocate Lutheran General Children's Hospital. He invented, developed, and obtained marketing authorization in India for a first-in-class resuscitative agent indicated for patients with massive blood loss. USFDA approved a phase III IND for hypovolemic shock and a phase II IND for ARDS. He leads the research, invention, and development of a novel drug to treat cerebral stroke in the late stages of clinical trials. In addition, he has discovered drugs potentially to treat Alzheimer's disease, hypoxic-ischemic encephalopathy, acute spinal cord injury, cardiac arrest, acute kidney injury, diabetic ketoacidosis, opioid tolerance, and dependence. Dr. Gulati has 54 issued patents. He is a recipient of the Outstanding Faculty Award 2017, Paul R Dawson Biotechnology Award 2014, and the distinguished Littlejohn Award 2014. Dr. Gulati is not only a United States Fulbright Scholar 2008-2009 but also a winner of the International Ranbaxy Research Award 2007. Dr. Gulati was the Scientific Reviewer of the United States Defense Medical Research and Development Program, Combat Casualty Care Research Program in 2016 and 2017. As the Professor and Associate Dean of Research, he promoted the medical research and faculty development of more than 50 faculty members. In addition, Dr. Gulati trained hundreds of medical residents and fellows to be research-oriented physicians and guided researches for more than 100 graduate students. He has ~300 peer-reviewed publications, 6,543 citations, an h-index of 45, an i10-index of 172. Dr. Gulati continues to forge ahead with discovering and developing new therapies for critically ill patients and his contributions to education and research.

Presenter of 3 Presentations

SOVATELTIDE (TYCAMZZI™) INDUCES NEURONAL REGENERATION IN THE ADULT MAMMALIAN CEREBRAL ISCHEMIC BRAIN BY STIMULATING ENDOTHELIN B RECEPTORS

Session Name
0620 - SHORT COMMUNICATIONS 02: ETIOLOGY AND CLINICAL PRESENTATIONS 02 (ID 410)
Session Type
E-Poster
Date
Wed, 26.10.2022
Session Time
10:00 - 11:30
Room
GALLERY
Lecture Time
10:00 - 10:00

SOVATELTIDE (TYCAMZZI™) INDUCES NEURONAL REGENERATION IN THE ADULT MAMMALIAN CEREBRAL ISCHEMIC BRAIN BY STIMULATING ENDOTHELIN B RECEPTORS

Session Type
Clinical Manifestations
Date
Wed, 26.10.2022
Session Time
10:00 - 11:30
Room
Room 332
Lecture Time
10:12 - 10:16

Abstract

Background and Aims

We have demonstrated that sovateltide, an endothelin B Receptors (ETBRs) agonist, effectively treats cerebral ischemic stroke, and its potential to develop as a novel drug for acute cerebral ischemic stroke (ACIS) is being evaluated (NCT04046484). In the present study, we have assessed the effect of sovateltide on neuronal regeneration and repair after ACIS.

Methods

We investigated the effect of sovateltide in permanent middle cerebral artery occluded (MCAO) adult rats. MCAO rats were treated with either sovateltide (5 µg/kg body wt.) or saline (equal volume) through tail vein injection and were assessed at 24 hrs or day 7 post-MCAO.

Results

We observed upregulation of neuronal differentiation markers Doublecortin (DCX) (p=0.00011), HuC/HuD (p=0.0037) along with NeuroD1 (p=0.00002) at 24 hrs post MCAO. Decreased infarct volume and DNA damage in the sovateltide group on day 7 post MCAO was observed. Downregulation of mitochondrial fission marker, DRP1 (p<0.001), increase in fusion marker, MFN2 (p<0.0001), and increase in cross-sectional area x number as well as mitochondrial/tissue area (p<0.05) at 24 hrs and day 7 post MCAO were seen. Increased mitochondrial DNA (MT ATP8; p=0.0418) was observed, indicating better mitochondrial biogenesis at day 7 post MCAO. Sovateltide treated rats had better neurological outcomes and motor functions at day 7 post MCAO. In vitro testing of sovateltide mediated differentiation in cultured rat NPCs demonstrated higher survival and expression of NeuroD1 and NeuN (a mature neuronal marker) after 24 hrs.

Conclusions

Sovateltide promotes differentiation of NPCs and mitochondrial fusion and biogenesis and helps in neuronal regeneration and function restoration following ACIS.

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A RANDOMIZED MULTICENTER STUDY TO DETERMINE THE EFFICACY OF SOVATELTIDE (TYCAMZZI™) IN PATIENTS WITH CEREBRAL ISCHEMIC STROKE

Session Type
Plenary Session
Date
Sat, 29.10.2022
Session Time
11:30 - 13:00
Room
Summit 1
Lecture Time
12:27 - 12:37

Abstract

Background and Aims

Sovateltide (Tycamzzi™) in animal models of acute cerebral ischemic stroke (ACIS) increased cerebral blood flow, had anti-apoptotic activity, and produced neurovascular remodeling when administered intravenously. In addition, it was safe and well-tolerated in healthy human volunteers, and it improved neurological outcomes in patients with ACIS 90 days post-treatment (NCT04046484).

Methods

A phase III study fully enrolled 158 patients with ACIS, of which 138 completed 90-day follow-up. All patients received standard treatment and were randomly assigned to either control (saline; n=70) or sovateltide cohort (n=68). The inclusion and exclusion criteria are at NCT04047563. Clinical outcome parameters NIHSS and mRS for ACIS were determined. Standard treatment and care were provided to all the patients. Sovateltide or normal saline was administered in three doses, each 0.3 μg/kg, as an intravenous bolus over 1 min at an interval of 3 ± 1 h on day 1, day 3, and day 6 post-randomization.

Results

Patient demographics and baseline characteristics were comparable between the two groups, including baseline NIHSS (saline 10.82 ± 0.41; sovateltide 9.79 ± 0.34) scores. The number of patients having a reduction of 2 or more in mRS was 52.86% in control and 72.06% in the sovateltide group (p=0.0199). mRS in the group treated with sovateltide compared to the comparator group at 90 days after treatment was significantly lower (p=0.0081). NIHSS showed similar improvement in the sovateltide group (p=0.0028) compared to the control group at 90 days of treatment.

Conclusions

Sovateltide significantly improved neurological outcomes in patients with acute cerebral ischemic stroke.

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