Korean biopharmaceutical firm GemVax & Kael said it has started to recruit patients for phase 2 clinical trial of “GV1001” to treat Alzheimer’s disease, the company said Monday.
The clinical trial will apply a cloud-based integrated data platform from Medidata Solutions for the first time, it said. The solutions used for the platform will comprehensively collect, maintain and report clinical trial data and support randomization to maximize trial effectiveness, according to the company.
GV1001 is a peptide drug derived from hTERT (Human Telomerase Reverse Transcriptase) consisting of 16 amino acids. The drug is highly likely to succeed as a treatment for Alzheimer's disease as it inhibits the accumulation of amyloid beta and suppresses the condensation of tau protein, preventing inflammation in neurons, the company said.
Professor Koh Seong-ho고성호 of neurology at Hanyang University Guri Hospital한양대구리병원 will lead the phase 2 clinical trial at five clinical sites -- Hanyang University Guri Hospital, Korea University Anam Hospital고려대안암병원, Ewha Womans University Mokdong Hospital이화여대목동병원, Inha University Hospital인하대병원,and VHS Medical center중앙보훈병원.
“There are no disease-modifying drugs currently available to treat patients with moderate to severe Alzheimer’s disease and leading biopharmaceutical firms’ various clinical trials have failed,” said Song Hyoung-gon송형곤, chief of the bio business department at GemVax & Kael(CEO: Kim Sang Jae김상재). “Because Alzheimer’s is the one which must be overcome in this aging society, having this clinical trial is very significant. The data we obtained prior to the clinical trial showed that the clinical trial can be successful.”
He added that Medidata’s and data analytics-based innovative solution will be implemented in any future clinical trials to be run by GemVax, and that he will bring all the resources for the success of domestic and the global clinical trial.
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