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