Promising Phase II results underpin GemVax decision to apply for expanded access IND for GV1001 in Alzheimer's Disease
SEOUL, South Korea, Oct. 6, 2020 /PRNewswire/ -- GemVax & KAEL (GemVax) a clinical stage company developing novel immunotherapies based on telomerase modification today announced the decision to apply for an expanded access IND for its lead candidate GV1001 to include additional investigational groups in Alzheimer's, a disease the WHO estimates to affect 24 million people worldwide, in its clinical development program. This pivotal decision is based on an encouraging recent analysis of results from a Phase II trial completed last year in Korea and if granted would apply to a second Phase IIb trial in the US now planned for early 2021.
The clinical report (CSR) by the CRO Paraxel on the Korean trial which involved 90 patients showed the primary endpoint was achieved with vaccinated participants holding steady at 24 weeks on the Serious Impairment Battery (SIB) (0.12 percent drop) whereas those on placebo dropped by 7.23 points. The report also revealed significant improvement in secondary outcomes, including the Neuropsychiatric Inventory (NPI) and Alzheimer`s Disease Cooperative Study-Activities of Daily living (ADCS-ADL).
"The CSR analysis, showing both improvement in SIB scores in patients with Alzheimer's disease and significant results in NPI and ADCS-ADL scores is highly promising," said Kim Sang-Jae, chairman of GemvVax. "It gives us the confidence to expand the range of indications targeted with GV1001 to include mild (not severe) Alzheimer's disease and cognitive impairment and potentially develop a new treatment for dementia."
GemVax had already registered a second Phase II clinical trial last year to be conducted in the US for moderate and severe Alzheimer's disease, but this has been delayed due to COVID-19. Recruitment is now back on track for early 2021 and will be expanded to include patients with mild cognitive impairment and mild symptoms.
About GemVax & KAEL
Based in Seoul, Korea, GemVax Group operates in two main areas: environmental protection and biopharmaceutical drug development. The biopharmaceutical arm, GemVax & KAEL was formed in 1998 and comprises Samsung Pharm, GemVax and FEELingK. It has brought to the market the first-in-class immunotherapeutic drug RIAVAX™inj for pancreatic cancer. Based on telomerase modification, the company's lead candidate GV1001 also has potential other indications in cancer and neurodegenerative diseases. www.gemvax.com
SOURCE GemVax & KAEL