Regeneus partners with Lonza for manufacturing CryoShot Canine cell therapy product for US FDA trial

Wednesday, 22 January 2014

Regenerative medicine company, Regeneus (ASX: RGS), announced today that Lonza, the world’s largest manufacturer of stem cells will manufacture Regeneus’ off-the-shelf cell therapy, CryoShot® Canine, for registration in the US.

“It is very exciting to be partnering with Lonza, a global manufacturer with specialist experience in manufacturing stem cells to the quality standards that the US and European regulators require for product registration”, said Dr Duncan Thomson, Head of Veterinary Health at Regeneus. “We view this as the start of a long-term relationship in which Lonza will manufacture CryoShot for the world wide canine market. 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.”

The cells will be manufactured at the Lonza facility in Walkersville, Maryland and then distributed to the participating trial veterinarian clinics.

CryoShot Canine is an off-the-shelf allogeneic cell therapy product for the treatment of musculoskeletal conditions in dogs and is currently under pre-registration trial in Australia. The cell therapy is produced from a small amount of adipose (fat) tissue derived from a donor animal. The tissue is processed and cultured to isolate and increase the regenerative cells before being cryogenically frozen and stored in liquid nitrogen. It is delivered to veterinary clinics cryogenically frozen and then thawed for injection by the treating veterinarian.

This follows the Regeneus company announcement on 14 November 2013 that Regeneus can proceed with the commercialisation of its novel canine cancer vaccine in the USA.