GemVax & KAEL said its drug candidate for Alzheimer’s disease got favorable reviews at the Dementia Forum X (DFX), the biggest Swedish international dementia forum, held at COEX in southern Seoul on Thursday.
The new treatment, “GV1001,” is a telomerase-derived peptide consisting of 16 amino acids. Telomerase is known to have various functions, including anticancer immunity, antitoxin effects, and cell protection.
During the forum, Dr. Philip Scheltens, director of Alzheimer Center at Vrije Universiteit, introduced GemVax’s GV1001 and the company’s clinical trials on severe dementia patients.
Its phase 2 clinical trial in Korea showed relative significance in three assessments-- self-injurious behavior (SIB) with a score of 7.11, neuropsychological inventory (NPI) and Alzheimer's disease cooperative study – activities of daily living scale (ADCS-ADL).
Based on the favorable results, the company will apply for its expanded applications to mild Alzheimer’s and mild cognitive impairment (MCI) soon, according to foreign advisors.
Professor Scheltens’ presentation stressed the candidate's competency and potential as a successful therapy for Alzheimer’s disease, according to GemVax. Scheltens explained the importance of the “significant improvement” in patients treated with GV1001 scored 7.11 at the SIB assessment because there were no such results in clinical trials of severe patients.
GemVax is preparing for phase 3 clinical trials in Korea, following the U.S Food and Drug Administration's recent proposal to expand indications for phase 2 clinical trials. Besides, the company plans to apply for additional confirmation on trials for Alzheimer’s patients with severe-and-above levels, for which GemVax has already won approval in the U.S.
“Based on these encouraging results, we will conduct clinical trials of GV1001 in Europe and the U.S., and Europe will include biomarkers in trials at our suggestion and continue to provide adequate assistance in developing new drugs during the process,” a GemVax official said.