Corestem applies for US FDA Phase 3 clinical trial of 'Neuronata-AL'

[Asia Economy Reporter Hyunseok Yoo] Stem cell bio company Corestem announced on the 19th that it has submitted a clinical phase 3 plan approval request to the US FDA for its stem cell treatment for amyotrophic lateral sclerosis (ALS), 'Neuronata-AL'.

Corestem stated that once approvals are completed, the phase 3 clinical trial, approved simultaneously by both countries, will be conducted domestically, and based on the clinical results, a Biologics License Application (BLA) will be submitted to the US FDA. Furthermore, based on these results, Corestem will submit the same clinical data to the Ministry of Food and Drug Safety (MFDS), fulfilling the post-approval confirmatory clinical trial obligations granted under the fast-track system in 2014 when conditional marketing approval was received.

Kwon Kwangsoon, Head of Corestem's Business Strategy Division, said, "We prioritized consultations with the MFDS regarding matters discussed in last year's meeting with the US FDA, incorporated all recommendations from the relevant department, and then established the clinical plan before submitting it to both countries." He added, "If approvals are obtained from both countries, it will be a pioneering case and a great opportunity for domestic clinical standards to be recognized globally." He further explained, "Conducting the clinical trial domestically means reducing the time and cost required for the US FDA marketing approval application by 50%, and after clinical approval, negotiations for technology transfer with global pharmaceutical companies will gain momentum."

He stated, "The biggest business goal this year is to start the US phase 3 trial in the first half and conclude a technology transfer agreement within the year," emphasizing, "Advanced bio-therapies such as cell therapy and gene therapy are sold at high prices overseas, so technology transfer agreements can receive high valuation."