GemVax Registers First Patient in Europe for Alzheimer's Disease Treatment Clinical Trial

France, Finland, Portugal IND Additional Approval... Approval Completed in 6 European Countries

GemVax & Kael announced on the 30th that it has registered the first patient in the Alzheimer's disease clinical trial currently underway in Europe.

A GemVax representative stated, "On the 29th, we registered a patient for the Phase 2 clinical trial of the Alzheimer's disease treatment in Spain," adding, "Following the United States, we are officially starting clinical trials in Europe as well."

The global clinical trial of GV1001 registered its first patient in the United States last October and has since completed registration of six patients. Recently, GemVax received approval for the Phase 2 clinical trial plan (IND) of the Alzheimer's disease treatment GV1001 in France, Finland, and Portugal. Additional approvals were obtained in three more countries: Spain, Poland, and the Netherlands.

The Phase 2 clinical trial of GV1001 for Alzheimer's disease conducted in Europe applies the clinical trial protocol approved by the U.S. FDA. The trial plans to recruit 77 patients in the United States and 108 patients in Europe, totaling 185 participants.

The clinical trial targets patients with mild to moderate Alzheimer's disease, administering subcutaneous injections of GV1001 at doses of 0.56mg or 1.12mg over 53 weeks (12 months) to evaluate the efficacy and safety of GV1001.

A GemVax representative said, "Out of the originally planned seven European countries, clinical trial approvals have been obtained in six," and added, "We will proceed with the global clinical trials in the United States and Europe without delay to demonstrate the efficacy and safety of GV1001."

GemVax recently received approval from the Ministry of Food and Drug Safety for the Phase 2 clinical trial plan of GV1001 for progressive supranuclear palsy (PSP). The first PSP clinical trial in Korea is about to begin. Following the actively conducted Alzheimer's disease clinical trials domestically and internationally, GemVax plans to expand the scope of GV1001 to neurodegenerative diseases in general by conducting the Phase 2 clinical trial for PSP.