Telomerase Peptide Improves Neuropsychiatric Symptoms of Alzheimer Disease in Phase 2 Trial
In a phase 2 trial for Alzheimer disease (AD) treatment with a peptide portion of the enzyme telomerase reverse transcriptase (TERT) (GV1001; GemVax & KAEL Co., Seoul, Korea) resulted in statistically significant improvement in the Severe Impairment Battery (SIB) and Neuropsychiatric Inventory (NPI). Improvement was also seen in AD Cooperative Study-Activities of Daily living (ADCS-ADL), but this did not reach statistical significance. Previously developed as a potential cancer vaccine, this peptide has been previously established as well-tolerated and safe. A phase 3 investigational new drug (IND) application is planned.
This phase 2 clinical trial evaluated the safety and efficacy of subcutaneous injection of 0.56 mg or 1.12 mg of the peptide for 6 months in participants with moderate-to-severe AD who were receiving donepezil for more than 3 months.
Professor Seong-Ho Koh, at Hanyang University Guri Hospital said, "The Severe Impairment Battery (SIB), the primary endpoint of this clinical study, showed an statistically significant greater improvement in the group treated with GV1001 1.12 mg compared with the control group treated with donepezil alone, which showed 7.11 difference in the overall SIB score. Among the secondary outcome results, the group treated with GV1001 1.12 mg had a significantly greater improvement in the Neuropsychiatry Inventory (NPI) scores compared with the control group. Furthermore, although found to be statistically not significant, the other secondary outcome, the AD cooperative study, Activities of Daily living (ADCS-ADL) score showed an apparent trend in improvement similar to the SIB results."
Kim Sang-Jae, chairman of GemVax said, "Combined with the notable improvement in SIB scores in patients with moderate-to-severe AD, these significant results in NPI and ADCS-ADL scores are extremely encouraging. We have decided to submit a phase 3 in Korea to see if it is possible to demonstrate improvement in a larger group of moderate-to-severe patients."