About My Health Careers Internship MedBlogs Contact us
Medindia LOGIN REGISTER
Advertisement

Anti-stroke Drug Proves Safe for Patients

by Shravanthi Vikram on February 21, 2018 at 3:48 PM
Font : A-A+

Anti-stroke Drug Proves Safe for Patients

Anti-stroke drug 3K3A-APC invented by The Scripps Research Institute (TSRI) showed promising results in patients with acute ischemic stroke. It also substantially reduced the incidence of hemorrhage in patients.

"These results lay the groundwork for the next steps toward FDA approval," says John Griffin, PhD, professor at TSRI, whose team invented 3K3A-APC.

Advertisement


Stroke is the fifth leading cause of death in the United States and the number one cause of adult disability. Acute ischemic strokes occur when a clot blocks blood flow to the brain. To date, the FDA has approved only one drug treatment, called tissue plasminogen activator (tPA), to treat acute ischemic strokes. tPA helps break up blood clots if given within a 4.5-hour window after the stroke.

Unfortunately, tPA's use is limited due to this brief treatment window and its potential to cause bleeding in the brain and neuronal cell death. But studies so far show that 3K3A-APC could complement tPA administration. Griffin designed the experimental drug by modifying just three amino acids on a naturally occurring blood protein called protein C, which is both an anticoagulant and a cell protective agent.
Advertisement

"This is an extremely novel drug," says Griffin.

Preclinical testing in collaborative studies involving Griffin's lab and the lab of Berislav Zlokovic, MD, PhD, director of the Zilkha Neurogenetic Institute at the University of Southern California, showed that 3K3A-APC lessens the damage of stroke and protects brain cells from the side effects of tPA. The drug was licensed by TSRI to the pharmaceutical company ZZ Biotech, where Zlokovic was the scientific founder.

To find the maximally tolerated dose, the National Institutes of Health's National Institute of Neurological Disorders and Stroke (NINDS) funded the recent Phase 2 study, called RHAPSODY, through a grant to the principal investigator Patrick Lyden, MD, chair of the Department of Neurology at Cedars-Sinai in Los Angeles, and through a NeuroNEXT Infrastructure Resource Access grant to ZZ Biotech, where Kent Pryor, PhD, served as co-principal investigator. NINDS entered into a Cooperative Research and Development Agreement (CRADA) with ZZ Biotech.

For the placebo-controlled dose-escalation trial, the researchers evaluated 3K3A-APC in patients with acute ischemic stroke treated with intravenous tPA, intra-arterial thrombectomy, or both. The scientists evaluated four doses of the drug: 120, 240, 360 and 540 μg/kg. Study participants, aged 18 to 90, were followed for 90 days. All doses were deemed safe and well tolerated.

As a secondary endpoint, the researchers evaluated cerebral hemorrhage in these patients. They found that total hemorrhage volume and hemorrhage incidence were both substantially reduced in 3K3A-APC-treated patients. The incidence of any hemorrhage was reduced from 86.5 percent in placebo-treated patients to 67.4 percent in the combined treatment arms. Total hemorrhage volume was likewise reduced from an average of 2.1±5.8 mL on placebo to 0.8±2.1 mL in the combined treatment arms.

The next steps for the researchers are to confirm and extend the successful Phase 2 study results in larger clinical trials.

Griffin says the collaborative environment at TSRI made the development of 3K3A-APC possible. "I've been blessed by working with fantastic people. TSRI has been committed to basic research and discovery of new knowledge, especially with translational potential--and that's been my philosophy."



Source: Eurekalert
Advertisement

Advertisement
News A-Z
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
News Category
What's New on Medindia
First-Ever Successful Pig-To-Human Kidney Transplantation
World Osteoporosis Day 2021 -
Spirituality and Mental Health
View all

Medindia Newsletters Subscribe to our Free Newsletters!
Terms & Conditions and Privacy Policy.

More News on:
Drug Toxicity Signature Drug Toxicity Drugs Banned in India 

Recommended Reading
Beauty Parlor Stroke Syndrome
Beauty parlor stroke syndrome is a form of vertebrobasilar insufficiency that causes symptoms of ......
Why Canadian Stroke Victims Die in Rural Hospitals?
The mortality rate of Canadian stroke victims is approximately 25 percent higher for patients who .....
Stroke Risk Higher Among African Americans With AF Than Caucasians
African Americans with atrial fibrillation are more at risk for stroke than Caucasians....
Hemorrhagic Stroke Can Be Treated With Special White Blood Cells
Along with carrying chemicals that could aggravate injury, neutrophils produce and release ......
Drug Toxicity
Drug toxicity is an adverse reaction of the body towards a drug that results as a side effect of a d...
Drugs Banned in India
Several drugs are either banned or withdrawn after introduction in the market....

Disclaimer - All information and content on this site are for information and educational purposes only. The information should not be used for either diagnosis or treatment or both for any health related problem or disease. Always seek the advice of a qualified physician for medical diagnosis and treatment. Full Disclaimer

© All Rights Reserved 1997 - 2021

This site uses cookies to deliver our services. By using our site, you acknowledge that you have read and understand our Cookie Policy, Privacy Policy, and our Terms of Use