(Yicai) April 8 -- Chinese biotech firm UniXell Biotechnology’s new cell therapy for intractable, or hard-to-treat, epilepsy has been cleared for clinical trials in both China and the United States, making the drug the first medicine in its field to reach the clinical stage in both countries.

UniXell’s allogeneic induced pluripotent stem cells-derived cell therapy, called UX-GIP001, was approved today by the National Medical Products Administration for clinical testing in China, the Shanghai Observer reported. Earlier, on March 12, the US Food and Drug Administration had already given it the green light to begin trials there as well.

There are about 70 million people worldwide living with epilepsy, which is caused by abnormal electrical activity in the brain and can lead to sudden loss of consciousness and involuntary movements of the limbs. Around a third of these patients suffer from intractable epilepsy, for which current therapies such as medication, surgery and neurostimulation are often ineffective.

The iPSC-derived cell therapy developed by Shanghai-based UniXell offers a completely new way of treating the condition. It involves implanting stem cells that can grow into specific types of inhibitory neurons into the damaged areas of a patient’s brain to repair the brain’s neural circuits and potentially cure epilepsy.

In animal studies, the results have been promising. About six months after the stem cells were implanted into mice, around 90 percent of seizure-related brain activity had disappeared. After eight months, the epileptic waves were almost undetectable, the report said.

UniXell was founded in 2021 by Chen Yuejun, a senior researcher at the Center for Excellence in Brain Science and Intelligence Technology under the Chinese Academy of Sciences who specializes in how stem cells develop into neurons. In February, the firm bagged CNY140 million (USD20.5 million) in an A+ round of financing that will be used to advance clinical trials of cell therapies for both epilepsy and Parkinson’s disease.

The company runs a research and development center and a Good Manufacturing Practice facility covering an area of 4,000 square meters in the China (Shanghai) Pilot Free Trade Zone. Its iPSC-derived cell therapy for Parkinson’s disease started Phase I clinical trials last year.

Editor: Kim Taylor