Regeneus lines up manufacturer for US CryoShot trial
Regeneus (ASX:RGS) has teamed up with stem cell manufacturing giant Lonza to pursue US registration for off-the-shelf cell therapy CryoShot Canine in the US.
Under the deal, Lonza will manufacture CryoShot Canine for an upcoming US marketing study of the product.
Regeneus received approval from the US Department of Agriculture in November to proceed with the trial as part of the commercialisation process. The study is scheduled to commence early this year.
Dr Duncan Thomson, Regeneus’ head of veterinary health, said Lonza has specialist experience manufacturing stem cells to the quality standards required by US and European regulators.
“We view this as the start of a long-term relationship in which Lonza will manufacture CryoShot for the worldwide canine market,” he said. “Our clinical trial work in Australia has been rewarding and it is now time to begin registration of the CryoShot product in the US and European markets.”
CryoShot Canine is an allogenic cell therapy for treating osteoarthritis and other musculoskeletal conditions in dogs. It is produced from adipose tissue of a donor animal. Regeneus is currently working on a human version of CryoShot using the same techniques.
Regeneus (ASX:RGS) shares were trading 5.1% higher at $0.515 as of around 1.30 pm on Wednesday.
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