The recently-developed stroke treatment ‘Neu2000’ has received approval for its 2nd phase clinical test from MFDS, Korea’s Ministry of Food and Drug Safety.
This approval has paved the path for treatment of patients within eight hours of discovering that they have suffered a stroke.
This is the first clinical study to prove the efficiency of the brain cell protection medicine on ischemic stroke patients receiving revascularization treatment.
The CEO of the company, Byung-ju Kwak, says, “Most people have failed in this area. However, we expect the 2nd phase of clinical test to provide us details of the precise effectiveness of the medicine.”
GNT Pharma is a company specializing in development of research products in the pharma field. The company will be starting Phase 2 of Clinical Study on stroke treatment having received approval from MFDS on the 2nd phase clinical study. The clinical study is being undertaken to prove the effect of the new stroke treatment ‘Neu2000’, which contains a new research medical substance that can give extended relief to those who have suffered a stroke.
This phase 2 clinical study will be performed on ischemic stroke patients that receive revascularization. The first clinical study was done to prove the effect of medicine on the brain cell.
The stroke clinical study of Neu2000 will be performed on 204 patients in Ajou University Hospital, Kyungpook University Hospital, Gacheon University Gil Medical Center, Keimyung University Hospital, Chosun University Hospital, and Chungbuk National University Hospital.
GNT Pharma was accredited for safety of the new medicine after they completed the first phase 1 clinical study of Neu2000. It was done on 165 healthy people, including elders in the U.S. and China.
GNT Pharma’s stroke treatment Neu2000 is known as the world’s first multi-target drug that suppresses toxicity of active oxygen and glutamate, which is a substance that induces brain cell damage after a stroke. Neu2000 has the ability to minimize brain damage. It also helps in administering antioxidants to suppress active oxygen or glutamate.
The company explains that in tests involving ischemic animals, the effect of the medicine is seen for eight hours. With Neu2000, the 3-hour golden time can be extended to maximum of 8 hours. This means patients can survive a stroke for longer period with this new wonder drug.
In this clinical study, Neu2000 is administered on patients receiving revascularization treatment within 8 hours being confirmed as having suffered a stroke through a CT scan. The effect of medicine will be evaluated for its level of disability, stroke index, daily life performance ability, and cerebral hemorrhage for a period of 12 weeks.
GNT Pharma CEO, Byung-ju Kwak, stated, “During the last 20 years, there were more than 200 clinical studies on stroke based on brain cell protection medicine. However, there were serious adverse effects and the golden hour time was short and this is where most studies failed.” He added, “This phase 2 clinical study is very crucial because we are doing in a challenging medical research area. We expect to give hope to many patients waiting for a breakthrough stroke medicine by accurately proving the effect of Neu2000 through this study.”
About GNT Pharma:
GNT Pharma is a company that specializes in developing groundbreaking medicines. The company was established in 1998 by 8 professors. They were researchers in neuroscience, pharmaceutical science, ophthalmology, and cell biology. The company that is currently developing ‘Neu2000’ and has applied for approval for phase 2 clinical tests in China through Zhejiang Apeloa Medical Technology which was affiliated with the top 500 groups of China in 2014. In Korea, the company has set a goal for completing Phase 2 clinical test within this year.
Definition of Terms
Glutamate is an excitant neurotransmitter that exists in the brain nerve cell. When stroke occurs, excessive amount of glutamate is discharged. It results in extinction of nerve cells through excessive activation of glutamate receptor. Due to this, stroke patients may suffer from permanent disability or death.
NMDA Receptor is a neuro-receptor known to control signal delivery between extinction of cells and normal cells.
Distributed by PRWorldwire
Company Name: GNT Pharma
Contact Person: Choi Won-seok
Phone: +82 10 9921 3570