As part of the preparations for a clinical trial, the company is required to
demonstrate the treatment's efficacy in an animal model that simulates spinal
cord injury in humans.
Therefore, a preliminary efficacy study was conducted as a preparatory step
towards a comprehensive definitive efficacy study (Proof of Concept – POC). A
contusion SCI in immunodeficient (“nude”) rats was conducted to simulate
autologous treatment in humans and examine its effects.
The interim results (8 weeks of follow-up out of 12) demonstrated a significant
advantage for the treatment group in BBB (Basso Beattie and Bresnahan) score, a
scale known for assessing motor function in rats.
The treatment's efficacy was demonstrated both in the percentage of animals
showing improvement and the strength of the improvement compared to the control
group.
The percentage of treated animals that exhibited improvement in the BBB score
was higher by 50% compared to the control group.
In addition, the treatment group exhibited three times the strength of
improvement in motor function compared to the control group.
Gil Hakim, CEO: "The company is investing significant efforts in developing
innovative technology for spinal cord injury treatment, a devastating medical
condition with no therapeutic solution, imposing an economic burden on health
systems estimated at tens of billions of dollars annually. The excellent
interim results are an encouraging sign and an important step towards beginning
the clinical trial".
