Medipost said Monday that it has received U.S. Food and Drug Administration (FDA)’s approval to conduct phase 1 and 2a clinical trials for Neurostem, an Alzheimer's disease treatment.
Neurostem is a drug based on mesenchymal stem cells derived from allogeneic umbilical cord blood.
With the approval, the company expects to conduct phase 1 and 2a clinical trials to evaluate the safety and efficacy of Neurostem in patients with mild to moderate Alzheimer's disease in the U.S.
The company plans to inject the drug in three-dose regimens in nine to 18 Alzheimer's patients that are expected to participate in the clinical trials.
The treatment is also undergoing phase 1 and 2a clinical trials in Korea. “As we are already conducting two clinical trials of stem cell treatment in the U.S., the clinical trials of Neurostem is expected to go smoothly,” a company official said.
According to a nonclinical animal study conducted in Korea, Neurostem’s applications included a variety of causative agents and pathological features of dementia such as reduction of amyloid beta protein, inhibition of tau protein hyperphosphorylation and aggregation, and inhibition of neuronal cell death.
Medipost also expects that the drug will be able to treat and prevent neural proliferation by helping the neural progenitor cells in the brain to differentiate into neurons, which will help in areas such as neuronal regeneration, the company said.