ASX listed biotech PharmAust now has sufficient data from testing of different tablet prototypes of its flagship Monepantel anti-cancer drug to take the best performing and most economical tablet for GMP manufacturing.
The company said data emerging from the tests on healthy Beagle dogs in collaboration with BRI Biopharmaceutical Research was better than expected and provides a strong basis to build its therapeutic Monepantel platform.
Levels of Monepantel in the blood using just one tablet exceeded the levels predicted to achieve anti-cancer activity.
These levels were calculated from PharmAust’s laboratory work on human cancer cell lines, animal testing on human cancer cell lines engrafted in mice and earlier clinical trials in human patients with cancer.
This blood analysis was not performed during the company’s earlier reported clinical pilot Phase II study in dogs with B-cell lymphoma due to ethical considerations.
However, extrapolation of the new tablet data indicates that the Monepantel levels in the blood of these healthy Beagle dogs, from a single tablet, exceeded the dose for anti-cancer activity required in the previous pilot study in dogs with B-cell lymphoma.
The selected tablets will be used in formal dose escalation studies in healthy Beagle dogs to determine the maximum dose that can be given and with what safety margin.
The company will then move on to its Phase II efficacy study in the first quarter of 2019.
Chief Scientific Officer Dr Richard Mollard said: “We can now continue on to the next step of formally confirming anticancer activity in target species in clinical trials using a very convenient delivery method and with a tremendous amount of knowledge of how the drug performs in the body.”
PharmAust recently reformulated Monepantel into tablet form and made it more palatable for man’s best friend.
Previous testing of Monepantel in dogs with lymphoma successfully achieved safety and effectiveness goals with six out of seven dogs achieving stability of disease and even a reduction in tumour size.
