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Contributor: PR Newswire Europe
Tuesday, March 30 2021 - 22:59
AsiaNet
GemVax's highly promising Phase II Alzheimer's disease clinical trial results targeting telomerase published in prestigious Alzheimer's Research & Therapy' journal
SEOUL, South Korea, March 30, 2021 /PRNewswire-AsiaNet/ --

GemVax & KAEL Co., Ltd. (Korea: 082270) ("GemVax") has announced that a paper 
on GV1001, a novel Alzheimer's treatment based on telomerase modification, was 
published on March 26th in the SCI-grade international journal 'Alzheimer's 
Research & Therapy'.

The paper is titled 'Efficacy and safety of GV1001 in patients with 
moderate-to-severe Alzheimer's already receiving donepezil: a phase 2 
randomized, double-blind, placebo-controlled, multicenter clinical trial', and 
contains an analysis of the overall data from the Phase II clinical trial for 
Alzheimer's disease conducted in Korea. Publication in such a prestigious 
peer-reviewed journal is regarded as further vindication of GemVax's decision 
to advance GV1001 into a Phase III trial in Korea later this year.

The phase II clinical trial was conducted at twelve domestic institutions to 
evaluate the safety and efficacy of GV1001, and confirmed statistically 
significant improvements in both the primary and secondary endpoints, the 
Severe Impairment Battery (SIB) (7.1 points) and the neuropsychiatric inventory 
(NPI) score, respectively. In particular, GV1001 was well tolerated without any 
clinically significant side effects or adverse drug events. 

Professor Seong-Ho Koh, the PI of the clinical trial, of the Department of 
Neurology at Hanyang University College of Medicine stated, "We are very 
pleased to have our research being recognized by this world-renowned journal 
for Alzheimer's disease research. As recognition of GV1001's research 
performance as a treatment for Alzheimer's disease continues in Korea and 
abroad, interest in future clinical trials will be higher both domestically, 
and globally."

A GemVax official said: "The publication of GV1001 phase II Alzheimer's disease 
clinical trial results in the highly prestigious journal 'Alzheimer's Research 
& Therapy' is an undisputable success and scientifically meaningful 
achievement. We will continue to strive in the upcoming clinical trials 
domestically and abroad to develop what we hope be a truly breakthrough 
treatment of Alzheimer's disease." 

Meanwhile, GemVax recently submitted GV1001's Phase III clinical trial 
Investigational New Drug (IND) application for Alzheimer's disease to the 
Ministry of Food and Drug Safety and is preparing follow-up procedures. 
Furthermore, GemVax is continuing close consultations with US CROs to expedite 
a Phase II clinical trial in that country following FDA approval to also 
include patients with mild disease.

'Alzheimer's Research & Therapy' is one of the world's top 10% of most 
prominent international journals in the field of Alzheimer's disease. 

Link: https://link.springer.com/article/10.1186/s13195-021-00803-w#citeas  

Contact:  
Richard Hayhurst 
+44 7711 821527 
richard@rhapr.eu 
   
Source: GemVax
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Japanese