UPDATE : Friday, November 15, 2019
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FDA OKs Gemvax & Kael's Alzheimer treatment for P2 trials
  • By Lee Han-soo
  • Published 2019.05.07 16:09
  • Updated 2019.05.07 17:37
  • comments 0

Gemvax & Kael has obtained U.S. Food and Drug Administration's investigational new drug (IND) approval to conduct a phase 2 clinical trial on GV-1001, an Alzheimer treatment.

Gemvax & KAEL headquarters in Seongnam, Gyeonggi Province.

With the approval, the company plans to confirm the drug's safety and efficacy on 90 patients at 20 medical institutions in the U.S.

Alzheimer's disease is a neurodegenerative disease caused by the accumulation of beta-amyloid and condensation of tau proteins, which cause neuronal and glial cell communication damage, inflammation and cell death. The illness eventually impairs neuronal cell function and reduces cognitive function, which makes normal daily life difficult.

GV1001 is a peptide derived from hTERT (Human Telomerase reverse transcriptase) consisting of 16 amino acids. The enzyme telomerase maintains the length of telomere located at the ends of chromosomes, and the treatment has anti-inflammation, anti-oxidation cellular protective effects, as well as anti-cancer effect.

The company had been working with several dementia researchers to investigate the action mechanism of GV1001 on Alzheimer's disease. In Korea, too, the company is conducting phase 2 clinical trials with 12 medical institutions and expects to confirm the result by the end of this year.

"We have been working hard to develop GV1001 as an innovative treatment for Alzheimer's disease," a company official said. "We will do our best to ensure that clinical trials are successful in the U.S."


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