SanBio, a regenerative medicine company in Mountain View, California, has announced the randomization of the first enrolled patient in the ACTIsSIMA Phase 2B clinical trial. This trial will examine the efficacy of SanBio’s proprietary SB623 product in patients who suffer from chronic motor deficits as a result of strokes. SB623 consists of modified adult bone-marrow-derived stem cells. A secondary purpose of this trial is to evaluate the safety of SB623 in these patients.
Ischemic strokes account for about 87 percent of all strokes in the United States. Ischemic strokes occur when there is an obstruction in one or more of the blood vessels that provide blood and oxygen to the brain. On the order of 800,000 cases of ischemic stroke occur in the United States every year, and it is the leading cause of acquired disability in the United States. Present drug treatments for stroke either try to prevent strokes or address patients who have recently suffered a stroke. Unfortunately, there are no medical treatments currently available for people who live with the effects of stroke, months or even years after suffering a stroke.
SB623 cells are derived from bone marrow mesenchymal stem cells extracted from healthy donors. These cells are designed to promote recovery from injury by triggering the brain’s natural regenerative ability. SB623 cells have been genetically engineered to express a modified version of the Notch gene (NICD) that conveys upon the cells the ability to promote the formation of new blood vessels and the survival of endothelial cells that form these new blood vessels (see J Transl Med. 2013, 11:81. doi: 10.1186/1479-5876-11-81).
SB623 was tested in a Phase 1/2A clinical trial in which SB623 was implanted into stroke patients and produced some improved motor function.
This follow-up trial, ACTIsSIMA, will treat stroke patients with SB623 cells in order to examine the safety and efficacy of SB623 cells. All patients in this trial have suffered from a stroke anywhere from six months to five years. Also, all patients must exhibit chronic motor impairments.
Damien Bates, M.D., Chief Medical Officer & Head of Research at SanBio, said, “Our previous trial suggested there was potential for SB623 to improve outcomes for patients with lasting motor deficits following an ischemic stroke. Randomization of the first subject marks an exciting step toward further evaluating this treatment as a promising new option for patients.”
For this trial, SanBio is collaborating with Sunovion Pharmaceuticals, Inc. Sunovion is a wholly owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd., and SanBio and Sumitomo Dainippon Pharma have entered into a joint development and license agreement for exclusive marketing rights in North America for SB623 for chronic stroke.
The ACTIsSIMA trial will include approximately 60 clinical trial sites throughout the United States, and total enrollment is expected to reach 156 patients.