GemVax & KAEL Announces the Decision to Apply for an Expanded Access IND for Its Lead Candidate GV1001 to Include Additional Investigational Groups in Alzheimer's
October 06, 2020 at 06:27 am EDT
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GemVax & KAEL 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). 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.
GemVax & KAEL Co.,Ltd is a Korea-based company mainly engaged in the manufacture of pollution control equipment used in semiconductor manufacturing processes. The Company and its subsidiaries are engaged in the three categories of businesses: pollution control business, which manufactures chemical air (CA) filters, gas scrubbers, resins, coating resins and other environmental equipments and systems; anticancer and anti-inflammation business, which engages in development of cancer vaccines for infectious diseases, such as acquired immune deficiency syndrome (AIDS) and anti-inflammations, and IT business which mainly produces liquid crystal display (LCD) modules. The Company distributes its products within domestic market and to overseas markets.
GemVax & KAEL Announces the Decision to Apply for an Expanded Access IND for Its Lead Candidate GV1001 to Include Additional Investigational Groups in Alzheimer's
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