GemVax & KAEL said Wednesday that it has completed patient registration for the phase II clinical trial of GV1001 to treat patients who have Alzheimer’s disease.
|GemVax & KAEL headquarters in Seongnam, Gyeonggi Province.|
Alzheimer’s disease is a neurodegenerative disease caused by the accumulation of beta-amyloid and condensation of tau proteins, which cause neuronal and glial cell communication damage, inflammation and cell death. The illness eventually results in the impaired neuronal cell function and decreased cognitive function, which makes normal daily life difficult.
GV1001 is a peptide derived from hTERT (Human Telomerase reverse transcriptase) consisting of 16 amino acids. The enzyme telomerase maintains the length of telomere located at the ends of chromosomes, and the treatment has anti-inflammation, anti-oxidation cellular protective effects, as well as anti-cancer effect.
The completion of registration comes after the company started conducting the phase 2 clinical trials at 12 clinical sites, including Hanyang University Guri Hospital, evaluating the safety and therapeutic efficacy of GV1001 in patients with moderate to severe Alzheimer’s disease in August 2017.
The company plans to evaluate the drug’s safety and efficacy on patients with moderate to severe Alzheimer’s disease who have received a cholinergic drug called donepezil for three months or longer, by subcutaneously administering either 0.56mg or 1.12mg of GV1001.
The trial is the only clinical trial that targets patients with moderate to severe Alzheimer’s disease, among 15 Alzheimer’s disease clinical trials currently conducted in Korea.
The company previously confirmed that GV1001 has various mechanisms for treating Alzheimer’s disease such as inhibition of beta-amyloid accumulation and condensation of tau protein in neurons through basic research.
GemVax expects to complete the trial by the end of this year and publish the result.
“There were difficulties in enrolling subjects and conducting the trial since the patients with moderate to severe Alzheimer’s disease must be accompanied by a caregiver,” GemVax & KAEL CEO Song Hyoung-gon said. “We expect to see meaningful results of this clinical trial to demonstrate the potential of GV1001 as a treatment method for Alzheimer’s disease.”
The company has also worked to submit an investigational new drug (IND) application to the U.S. Food and Drug Administration, and is now in the final stage of filing the related documents, Song added.
According to the GlobalData, a market research firm, the global Alzheimer’s disease market size in the seven major countries -- U.S., France, Germany, Italy, Spain, U.K. and Japan – was about $3 billion in 2016 and will reach $14.6 billion by 2026.
Drugs currently used in clinical practice have the effect of delaying the progression rate of the disease for a certain period, but there are no disease-modifying drugs available to cure the disease altogether.