GemVax Seeks Expanded Access for Mild Alzheimer’s for Planned GV1001 US Trial

GemVax Seeks Expanded Access for Mild Alzheimer’s for Planned GV1001 US Trial
GemVax & KAEL has filed for expanded access of its U.S. Food and Drug Administration (FDA) investigational new drug (IND) application for GV1001, its experimental treatment for Alzheimer's disease. The company is seeking to include additional investigational groups in its clinical development program. The filing comes following positive results of a Phase 2 clinical trial (NCT03184467) of the therapeutic candidate, conducted in Korea. "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," Kim Sang-Jae, chairman of GemVax, said in a press release. The expanded access would extend to a second Phase 2b trial (NCT03959553) in the U.S. Expected to launch in 2021, that planned trial would involve patients with mild cognitive impairment and mild symptoms caused by Alzheimer's. GV1001 was origi
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