A sad, but not surprising day for the stem cell field as the biotech StemCells, Inc. announced that it is winding down its operations after terminating its spinal cord injury trial called the Pathway Study. The data generated so far did not justify continuing the trial.
StemCells, Inc. (stock symbol STEM) has struggled financially for quite some time. In February of this year I asked if the company could cheat death given how bad things were looking and what I was hearing through the stem cell grapevine. Unfortunately the answer appears to be “no”.
I interviewed the leadership of the company two years and they were optimistic about the company’s outlook at that point. However, STEM CEO Marty McGlynn departed earlier this year and that was seen as another sign of things not looking bright.
Dr. Stephen Huhn, Chief Medical Officer and VP of Clinical Research was quoted in the press release today that the scientists felt there was some signal of efficacy and they were encouraged by the safety profile:
“Data from earlier clinical trials involving the Company’s proprietary HuCNS-SC® human neural stem cells have demonstrated an early signal of biological activity in multiple disease indications. Our earlier Phase I/II clinical trial in chronic thoracic spinal cord injury showed measureable gains, while the Phase I/II clinical trial in geographic atrophy showed a positive safety profile and favorable preliminary efficacy. Additionally, a Phase I study in children with Batten’s disease showed that transplantation of the cells into the brain was safe and resulted in long term survival of the cells.”
The company has been somewhat controversial on a number of levels as I posted about previously including concerns over the funding ($20 million at one time) it received from CIRM, former CIRM President Alan Trounson joining the leadership of STEM shortly after leaving the agency, and other issues.
The hope is that despite the company ultimately closing that this kind of stem cell clinical science can continue as there is a huge need for new therapies for a variety of conditions including spinal cord injury and paralysis. Perhaps another company will purchase the IP here and build on some of the earlier work.
I’m planning to post more of a kind of thorough post-mortem for the company later this week. There’s a lot to think about here. For instance, a fair question today is how we should now process CIRM’s sizable investment in STEM. Is there anything that can be learned from it for the agency and the field?