Mountain View, CA-based SanBio is poised to start the first global Phase II chronic traumatic brain injury clinical trial to ever be conducted in Japan using a stem cell therapy--a milestone that comes a year after it listed on the Tokyo Stock Exchange.
The trial, using allogeneic stem cells, was cleared by Japan's Pharmaceuticals and Medical Devices Agency (PMDA) following a 30-day Clinical Trial Notification period submitted on March 7 and that "passed without further concern," according to a press release.
The candidate, SB623 or Stemtra, has been used in U.S. clinical trials on chronic stroke patients who have not responded to conventional therapies. The candidate, if approved, would be sold in the U.S by Osaka-based Sumitomo Dainippon Pharma. In Japan, Tokyo-based Teijin bought a 7% stake in SanBio in 2010 for $5 million and would handle any sales in that market.
U.S. enrollment in the safety and efficacy study of SB623 started in October 2015. The overall trial will cover 52 patients, including the Japan leg.
"SanBio's regenerative cell medicine, SB623, has improved outcomes in patients with persistent motor deficits due to ischemic stroke, and our preclinical data suggest it may also help TBI patients," Damien Bates, chief medical officer and head of Research at SanBio, said in a statement.
"This is the first global Phase II clinical trial for TBI with allogeneic stem cells, and the approval to conduct the trial in Japan, as well as in the United States, brings us one step closer to determining SB623's efficacy for treating those who suffer from the effects of traumatic brain injury."
SanBio expects the Japan leg of the trial to start this year, according to the release, adding that a $1 billion credit line arrangement with Mizuho Bank as well as cash raised from the listing in April last year will fund the study.
- here's the release