Seneca Biopharma has announced its preliminary top-line results of the placebo-controlled phase II stroke study that was conducted in Beijing, China.
According to a company press release, the trial was designed to evaluate the relative safety of Seneca Biopharma’s human neural stem cell therapy (NSI-566) in patients with stable deficits in motor function resulting from ischaemic stroke. Patients were eligible for the trial if they had documented history of ischaemic stroke at least four months, but no more than 24 months, before surgery.
The company states that the study enrolled 23 patients who were randomly assigned to treatment or placebo arms. Patients in the treatment arm received an intracerebral injection of 72 million stem cells, whereas those in the placebo group underwent a sham surgery procedure. Secondary objectives to evaluate efficacy were performed by qualified assessors who were blinded to treatment assignment and included the Fugl-Meyer Motor Score (FMMS), an assessment of upper and lower motor function that comprises a 100 point scale and is widely used following stroke.
Patients enrolled in the treatment and placebo arms had similar baseline FMMS scores before surgery (mean ± SD: 36.80 ± 8.59 and 35.80 ± 4.66, respectively). While most participants showed some improvement in FMMS from pre-surgery scores, the mean improvement after one year was greater in those participants receiving NSI-566 (n=10, mean ± SD: 12.20 ± 14.15) compared to placebo (n=10, 6.30 ± 5.14), though the difference between groups did not reach statistical significance using the approximate Student’s t-test (MMRM) (p=0.231).
Two participants in the treatment arm showed clinically important improvements of 32 and 44 points on the FMMS following treatment with NSI-566, whereas the largest improvement observed in the placebo group was 17 points. Participants in the treatment arm experienced a total of three serious adverse events (SAE) that were considered by the investigator to be probably or possibly related to treatment, whereas no patients in the placebo arm experienced SAEs. Treatment-related SAEs were resolved with standard medical care and were limited to impaired healing at the incision site and wound dehiscence in one patient, and impaired hepatic function in another.
“Stroke is a leading cause of death and disability in China,” said Ruxiang Xu ( Beijing, China), former president of BaYi Brain Hospital and study principal investigator. “Results from this study show NSI-566 may have utility as a treatment for paralysis and motor deficits caused by ischaemic stroke. Additional larger studies will be critical in demonstrating the clinical potential of NSI-566 in this unmet need.”