Regenerative medicine company, Regeneus' (ASX: RGS) shares should open higher today, after gaining approval for its canine cancer vaccine to move to commercialisation in the U.S.
Written confirmation was received from the Center for Veterinary Biologics at the US Department of Agriculture that Regeneus can proceed with the commercialisation of its novel canine cancer vaccine in the U.S.
Significantly, the vaccine has been through pre-clinical testing at the Kolling Institute in Sydney which demonstrated that it could induce remission or significantly slow tumour growth in an aggressive glioma animal model.
The vaccine involves removal of a tumour or biopsy from the dog in order to produce a personalised vaccine. This use of the dog's own tumour proteins as the source of the biological therapy has cleared the way for faster approval and commercialisation.
With cancer accounting for almost half of the deaths of pets over 10 years of age, this provides a large market and a potential prize for Regeneus' cancer vaccine.
Regeneus holds an exclusive worldwide licence for commercialisation of the technology for veterinary applications - and an option over all human applications as well.
The technology was developed at the Royal North Shore Hospital in Sydney by Prof Ross Davey and Dr Chris Weir at the Bill Walsh Translational Cancer Research Laboratories which is part of the Kolling Institute of Medical Research.
The vaccine involves removal of a tumour or biopsy from the dog in order to produce a personalised vaccine.
The vaccine stimulates the dog's immune system to see the cancer cells as foreign and helps prevent further growth of the tumour as well as development of new tumours.
According to the National Canine Cancer Foundation, cancer accounts for almost half of the deaths of pets over 10 years of age, which is roughly the same rate as humans.
Since March 2011, Dr Weir personalised vaccines to treat 40 dogs with a range of life threatening tumours.
Cancers treated include melanoma, bone cancer and liver cancer.
Dr Weir said: "The study demonstrated that there were no adverse side effects from the vaccine and over 80% of dogs treated had increased survival times as compared to published survival data for these types of cancer.
"I'm confident that we'll see positive results from the controlled study planned for early next year."
"This is exciting news as it means we have an accelerated pathway to make our autologous vaccine available to treat dogs with life threatening cancerous tumours in the USA," said Dr Duncan Thomson, Head of Veterinary Health at Regeneus.
Professor Graham Vesey, CEO of Regeneus said: "The success of the vaccine to date in a variety of hard to treat cancers in dogs bodes well for a clinical study of the vaccine for human cancer in the near future."
"The next step is to finalise the planning and initiate our US based marketing study which will generate important data to support the commercialisation of the cancer vaccine. The study is scheduled to commence in early 2014," Thomson added.
That the vaccine has been through pre-clinical testing which demonstrated it could induce remission or significantly slow tumour growth in an animal is significant. That the novel cancer vaccine has been given written approval by the Center for Veterinary Biologics at the U.S. DoA starts to demonstrate how regenerative medicines are turning the traditional vaccine model into a new paradigm.
Using a dog's own tumour proteins as the source of the biological therapy leads to faster approvals for commercialisation; outcomes can be transformed into vaccines and products able to be plied and sold commercially that produce revenues in a faster timeline.
Importantly, Regeneus holds an exclusive worldwide licence for commercialisation of the veterinary technology so the IP is strong.
For this particular application for pets - Regeneus also holds an option over all human applications as well - the potential market for its vaccine is significant as the cancer accounts for almost half of the deaths of pets over 10 years of age.
This is a value-accretive outcome for Regeneus, we consider this to be just the start.
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