Israel-based Kadimastem, a biotechnology company developing cell therapies for the treatment of severe debilitating diseases announced positive interim results from the Phase 2 clinical trial.
The company’s lead product, AstroRx, showed a positive efficacy signal and a good safety profile in a clinical Cohort B Phase 1/2a in ALS.
The comparison between the ALSFRS-R change before and after treatment conveys a clinically meaningful decline of more than 50% in disease progression rate for a period of 3 months for both cohorts,” said Kadimastem CEO Rami Epstein.
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“The effect was even more profound in patients who deteriorate rapidly. Repeated administrations of the treatment, planned to be assessed in future clinical trials, will hopefully extend the duration of the beneficial effect. These results strengthen our commitment to bringing an innovative therapeutic treatment to ALS, a devastating disease currently having no effective treatment.”
“The positive interim results of Cohort A and B strongly support our next global clinical development stages, added Epstein. “We are now focused on advancing strategic FDA regulatory processes that will necessitate the conduct of global multi-center clinical trials. In support, the Company is also dedicating resources to production process scale-up as well as to the development of a 2nd generation of AstroRx as a frozen product that will accelerate our clinical development plan to support market authorization,” he said.