ASX listed biotech company PharmAust is set to take things up a notch with the start of Phase I clinical trials for its flagship anti-cancer drug Monepantel in dogs later this month after settling on a final tablet format.
The company has executed an agreement with a major US contract research organisation to start the trial, which will be carried out on healthy dogs, on 19 February 2019.
This is designed to provide information on the number of tablets, administration frequency, blood levels and verification of safety for the Phase II trials in pet owners’ dogs with naturally occurring cancers.
Notably, a successful Phase I trial design can also be used as a bridging study to support US Food and Drug Administration Investigative New Drug application for clinical trials in humans.
PharmAust has also finalised its monepantel tablet research and development and has now completed the first scale batch production of 2000 tablets for the Phase I trial.
Chief Scientific Officer Dr Richard Mollard said: “The trial design should provide the required information to enable the best possible treatment for pet owners’ dogs with cancer in the upcoming Phase II trials.”
“Further, because Monepantel is now in a tablet instead of a liquid, the safety component of this trial design would potentially form part of the bridging component required for regulatory authorities such as the FDA for establishing an Investigative New Drug Application for clinical trials in humans”.
Dr Mollard added that defining a process to manufacture a large number of Monepantel tablets was an important step for PharmAust as it allowed the company to proceed with the Phase 1 trial using a standardised and regulatory compliant tablet.
“The production of this tablet further paves the way for the next manufacturing round, to provide Monepantel for the Phase II program and for determination of anticancer efficacy in pet owners’ dogs with naturally occurring cancers,” he said.
Laboratory testing of Monepantel manufactured using the recently determined good manufacturing practice process at the Olivia Newton-John Cancer Research Institute, or “ONJCRI”, in Melbourne continued to kill cancer cells without affecting non-cancerous cells.
This is a major leap forward in an industry where many cancer fighting methods tend to kill the good cells with the bad.
Research by ONJCRI has also demonstrated that Monepantel’s principle end-product, metabolite Monepantel Sulfone, retains the same biological activity as the drug itself, providing enduring and specific effect through a “double kick” to cancer cells.
The upcoming Phase I trial using the final tablet format is a major step forward for PharmAust.
Not only will the company provide the safety and dosage data to proceed with Phase II clinical trials in dogs with cancer, it could also help fast track the road to starting clinical trials of Monepantel in humans.
This is a good example of forward thinking on the company’s part and the next couple of months will certainly be interesting to watch.
