GMP Bio∙C&R Research Will Begin Alzheimer Treatment Clinical Trial Phase 1/2a in Australia
Plan to Collect Caucasian Data Through Phase 1/2a
Seoul, Korea, October 12, 2018 — GMP Bio, a subsidiary of GMP Co., Ltd., will begin clinical trials in Australia for Alzheimer’s treatment (GB301) through C&R Research, a CRO, using the Regulatory T cell technology.
GMP Bio and C&R Research are planning to collect data on Caucasians in phase 1/2a, which will take place in Australia. Following the confirmation of drug safety and efficacy, they plan to conduct further clinical trials for FDA approval.
According to GMP Bio, the Regulatory T cells from ‘Project GB301’ showed excellent results in animal efficacy assessment of various degenerative brain diseases. Therefore, the company decided to target Alzheimer’s disease, which has the highest unmet medical needs. Currently, GB301 is in the final stage of its toxicity test at the Non-clinical Research Institute of ChemOn, an institute specializing in pre-clinical studies. GMP Bio explained that they should be receiving the final report by November as there were no unusual issues related to toxicity so far.
A GMP Bio official indicated, “Before conducting clinical trials in the U.S., we are planning them in Australia where we can run quick and efficient studies. Our phase 1/2a trial in Australia is the world’s first clinical trial to confirm GB301’s safety and efficacy in the human body. In order to achieve high-quality outcomes, we are discussing clinical protocols and exchanging our insights on the project with 2-3 internationally renowned clinical trial managers from Australia, and we are about to conduct clinical trials based on the discussion.”
In the Australia clinical trial, C&R Research will be in charge of overall project management, data management and statistical analysis using CDISC standards.
A C&R Research official stated, “An increasing number of Korean bio ventures are expanding to global markets through Korean CROs. This collaboration will allow C&R Research to grow and thrive moving forth, and we plan to discover more projects that will contribute to the global pharmaceutical industry.”
Project GB301 is a cell therapy drug that focuses on the aspect that the immune system overreacts to wastes generated by brain activity and obliterates normal brain cells around it. The essence of the project is to run an in vitro culture of Regulatory T cells (CD4+CD25+CD127dimFOXP3+), which are cells with immunosuppressive functions that exist in the blood, using a specialized culture method by GMP Bio to proliferate Regulatory T cells that react to the Alzheimer disease then inject them back in the body.