On June 26, GemVax & KAEL announced that it plans to provide GV1001 for Compassionate Use in Europe.
GemVax conducted a global Phase 2 clinical trial for Alzheimer's disease in the United States and seven European countries, involving 199 patients with mild to moderate Alzheimer's disease. As of the end of April, all patients had completed dosing.
Some of the clinical investigators for European patients who participated in the trial requested the provision of the treatment for Compassionate Use. GemVax will support GV1001 only for those who participated in the clinical trial.
Previously, in a domestic Phase 2 clinical trial targeting patients with moderate to severe Alzheimer's disease, GemVax demonstrated both efficacy and safety by confirming significant improvements in key evaluation indicators such as the Severe Impairment Battery (SIB) compared to the control group.
A GemVax representative stated, "We are pleased to be able to offer additional treatment opportunities to patients suffering from the disease through Compassionate Use," and added, "We hope to continue expanding treatment options and improving patients' quality of life through various forms of support in the future."
Compassionate Use is a system that allows investigational drugs to be provided to patients suffering from diseases for which there are no available treatments or that are life-threatening.
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