11th March 2019, New Delhi: Pharmazz India Pvt. Ltd during ‘Pharmazz investigator’s meeting’ presented its 09 years of research done for developing life saving drugs. These drugs developed by Pharmazz will be helpful in cases of accidents, maternal mortality, diarrhea, burns, etc. as these can control excessive blood loss or fluid loss from the patient’s body to such an extent that doctors can effectively get extra time of 6 – 7 hours to save the life. The event was attended by medical researchers from all parts of India and some from the US.
20 highly-credentialed Indians are executing human trial tests in 25 major Indian medical institutions, that address shock from serious blood loss, stroke from reduced blood supply to the brain, Alzheimer’s disease and injuries to the spinal cord.
“This conference shows Indian doctors and scientists collaborating on new technological answers to life-threatening challenges faced by millions of Indians,” Pharmazz Co-founder Anil Gulati, PhD, MD, said.
“Millions of Indians are afflicted by these injuries and diseases every year. For instance, we have very high rates of car crashes. People are injured and bleed. Millions have lost their lives from the blood loss. Our drug has already saved lives in clinical trials, and we hope it will be successful and save more,” Dr. Gulati said.
“Our aging population means many more Indian cases of Alzheimer’s disease are ahead. The drug we are testing has shown that in animal models it reduces the impact of the disease. Results in models of spinal cord injury are also encouraging. Human studies for Alzheimer’s disease and acute spinal cord injury are in progress.”
“India’s population is big enough to represent virtually every known medical condition. Our professionals are world-class and devoted to helping solve the biggest challenges we face. Pharmazz is very pleased to contribute to this great task. With success, we will strengthen India’s role in global pharmaceutical advances,” Dr. Gulati said.
The organization is conducting four clinical trials in India, under strict government authority and regulation. Pharmazz’s drug for bleeding out, Centhaquine, is in the final step of trials before consideration by the Drug Controller General of India.
Insight on drugs:
The research work caters to 4 segments: Hypovolemic Shock, Ischemic Stroke, Spinal Cord Injury and Alzheimer’s Diseases. The company has secured 2 International Non-proprietary Names (INNs), Centhaquine for PMZ-2010 and Sovateltide for PMZ-1620, from the World Health Organization. Its potential First-in-Class medicines will be the first, worldwide, to use these INN’s. Two brand names are now under development for worldwide use for Pharmazz’ Shock and Stroke medicines.
Drug product for shock: Centhaquine (PMZ-2010) uniquely and safely constricts veins that are pushing unused blood to the heart. It increases the amount of blood pumped out of the heart and simultaneously dilates the arterial blood vessels. Thereby, it greatly improves the blood perfusion of vital organs such as heart, brain and kidneys, and thus prevents organ failure from massive blood loss. It can be used to control massive blood loss due to trauma, bleeding from accidents, major surgeries, maternal postpartum haemorrhage, gastrointestinal bleeding, burns, extreme fluid loss due to vomiting and diarrhea.
Drug product for stroke: Intravenous administration of Sovateltide (PMZ-1620) activates dormant stem cells in the body’s Central Nervous System which induces regeneration of new neurons and blood vessels in the targeted area. It can be used for Ischemic Brain Stroke, Acute Spinal Cord Injury and Alzheimer’s Disease. Pharmazz’ patented drug products are designed to meet a global annual market estimated at more than $100 billion.
The company has focused on most important surrogate clinical endpoints of hypovolemic shock like blood pressure, blood lactate and base-deficit and survival.
How and when to use these drugs
Centhaquine will be available in vials to be reconstituted in saline and administered intravenously in patients of hypovolemic shock. Similarly, Sovateltide will be available in vials to be reconstituted in saline and administered intravenously in stroke patients. These drug will be available in emergency department of hospitals, trauma centers and ICUs. The drug is given intravenously.
Result of usage of the drugs
The company says considering the preclinical and clinical data till date, the chances of survival are very high. The drug has shown remarkable effects in patients of hypovolemic shock. Three most important surrogate clinical endpoints for hypovolemic shock are blood pressure, blood lactate and base-deficit, and our clinical phase II results demonstrate all three surrogate clinical points significantly (P<0.001) improved compared to standard of care.
The spokesperson(s) at the event were Dr. Anil Gulati (Inventor, founder and director of Pharmazz and Dean of Research at Midwestern University, USA), Dr. Birinder Marwah (Head of Geriatrics and Medical Director at Seasons in the USA), Dr. Suresh Havalad (Former Director of Pediatric Critical Care Division, Advocate Lutheran Hospital, USA) and Mr. Chris Robling, Business Entrepreneur, Illinois, USA.