GemVax's highly promising Phase II Alzheimer's disease clinical trial results targeting telomerase published in prestigious Alzheimer's Research & Therapy' journal

PR88771

SEOUL, South Korea, March 30, 2021 /PRNewswire=KYODO JBN/ --

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