SEOUL, South Korea, March 30, 2021 /PRNewswire/ -- 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.
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