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 originally developed as a vaccine for cancer, but failed to show efficacy in the treatment of pancreatic cancer in two clinical trials. The active ingredient of GV1001 is a peptide comprised of 16 amino acids, the building blocks of proteins, that is identical to an amino acid sequence from the enzyme telomerase reverse transcriptase (TERT). Many cancers express higher levels of TERT, so the GV1001 treatment was designed to prime the immune system to recognize the TERT sequence, to better recognize and eliminate cancerous cells that express TERT. Though GV1001 failed as a treatment for cancer, the researchers noted that non-cancerous cells showed lower levels of inflammation and oxidation in the presence of GV1001. Given this effect, the researchers pivoted to investigating whether GV1001 may act as a treatm
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