Cynata Contracts Leading CRO to Conduct Preclinical Studies
THE ROADHOUSE PHARMACY: Cynata Therapeutics (ASX: CYP) has signed an agreement with WuXi AppTec (NYSE:WX), a leading global biopharmaceutical contract research organisation, to conduct preclinical safety studies with Cynata’s unique Cymerus™ stem cell technology.
The studies will be conducted at WuXi AppTec’s GLP-compliant, FDA-registered facility in St Paul, Minnesota.
Cynata’s preclinical program has been designed following an in-depth review of the current regulatory expectations in major jurisdictions worldwide, which has included direct interaction with regulatory authorities.
The data generated from these studies will be key in supporting Cynata’s planned clinical trial program, which is expected to commence next year.
“We are very pleased to have engaged an organisation as proficient and well regarded as WuXi AppTec to conduct these vital studies,” Cynata vice president, product development Dr Kilian Kelly said in the company’s announcement to the Australian Securities Exchange.
“The team of scientists that will run this project has extensive experience conducting similar studies with other cellular therapy products, which gives us confidence that our program will be conducted to the highest standards.
“We expect these safety studies, as part of the broader preclinical program, to facilitate regulatory clearance of our planned clinical trial in graft versus host disease.”
Cynata explained the Cymerus™ technology facilitates large scale production of MSCs from a single donor, which it says is a key element for pharmaceutical companies as they move into stem cell medicine.
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