GemVax & Kael said on Thursday it completed the first patient registration of phase 2 clinical trials for its Alzheimer's disease treatment, GV1001, in Spain, following registration in the U.S.
GV1001's global clinical trial was first registered in the U.S. in October last year. So far, the company has enrolled six patients in total.
Additionally, GemVax recently received approval for a phase 2 clinical trial plan (IND) for the Alzheimer's disease treatment GV1001 in France, Finland, and Portugal. It also won the nod for the trial in Poland and the Netherlands.
The clinical trial plan approval is proceeding in Italy, which is the last remaining country in Europe.
The phase 2 clinical trial of GV1001 for Alzheimer's disease treatment, which is being conducted in seven European countries, uses a clinical trial plan approved by the U.S. FDA, and recruits 77 people from the U.S. and 108 people from Europe, totaling 185 people.
The trial will evaluate the efficacy and safety of GV1001 as a treatment for Alzheimer's disease by subcutaneous injection of 0.56 mg or 1.12 mg for 53 weeks in patients with mild and moderate Alzheimer's disease.
Following the clinical trial of Alzheimer's disease, which is being actively conducted at home and abroad, the progressive supranuclear palsy (PSP) phase 2 clinical trial will be conducted next, to expand the scope of GV1001 to the more neurodegenerative disease.
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