Gemvax & KAEL, which developed ‘RiaVax’, a pancreatic cancer treatment, is gaining momentum in the development of Alzheimer’s treatment.
Gemvax & KAEL announced on the 30th that it will start a phase 3 clinical trial to evaluate the efficacy and safety of GV1001 in patients with moderate to severe Alzheimer’s disease, which was approved by the Ministry of Food and Drug Safety in January.
The clinical trial will be conducted on 936 patients with moderate to severe Alzheimer’s disease at 50 domestic hospitals, including Inha University Hospital.
He also explained that GemVax is ahead of phase 2 clinical trials overseas.
GemVax has confirmed the safety and effectiveness of GV1001 in patients with moderate to severe Alzheimer’s disease through a phase 2 clinical trial conducted at 12 domestic medical institutions from August 2017 to September 2019.
Statistical significance was confirmed in the superior improvement effect (7.1 points) of the primary endpoint, the Severe Disability Score (SIB), and the neuropsychiatric behavioral test (NPI), a secondary endpoint. In particular, clinically significant side effects and abnormalities in the GV1001 administration group The reaction has not been confirmed.
Gemvax published the results of the Phase 2 clinical trial in the online version of ‘Alzheimer’s Research & Therapy’, a world-renowned international academic journal that ranks in the top 10% of Alzheimer’s disease and an SCI-level international academic journal, in March last year.
A Gembex official said, “We are concentrating all our capabilities for the smooth progress of domestic and overseas clinical trials, and we will do our best until all clinical trials are completed.”
GV1001 was originally developed as an anticancer drug, but it is a new drug candidate under development as a treatment for Alzheimer’s disease through mechanisms such as anti-inflammatory, antioxidant and cytoprotective effects.
GemVax received conditional approval for ‘RiaVax’, a new drug for pancreatic cancer treatment, using GV1001, but the license was canceled in August 2020 because it failed to fulfill the conditions of approval.
Gemvax said that it is in the process of a phase 3 clinical trial for Liabex, and plans to apply for official approval to the Ministry of Food and Drug Safety as soon as the results are obtained.
By Kim Yong-joo, reporter [email protected]
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