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Cynata Therapeutics Gets Positive European Opinion for Acute Graft Versus Host Disease Trial

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Cynata Therapeutics (ASX:CYP) received a positive opinion from the European Medicines Agency's Paediatric Committee for a plan to develop its CYP-001 product candidate for the treatment of acute graft versus host disease, according to a Wednesday filing with the Australian bourse.

The committee has agreed to the company's proposed pediatric investigation plan, which is a requirement to start a phase 3 clinical trial in the European Union.

CYP-001 is designed for intravenous use to modulate the immune system and improve response rates and survival outcomes in acute graft versus host disease, an often life-threatening complication of bone marrow transplantation and similar procedures, per the filing.

Cynata Therapeutics plans to launch a phase 3 clinical trial first in adults, and once the primary analysis of the adult trial is complete, it plans to start a pediatric clinical trial.

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