Australian biotech PharmAust has received the key ethics approval from the New South Wales Department of Primary Industry to proceed with the Phase II clinical trials for its anti-cancer drug Monepantel in dogs.
The approval covers the investigation of Monepantel tablets for their short-term and long-term effectiveness in achieving stable disease and progression-free survival or regression of tumours.
While the company previously secured approval to carry out the trial using the approved liquid formulation of Monepantel, this proved to be unpalatable for dogs, leading the company to develop a taste-neutral tablet formulation.
The tablet formulation is considered to be a new veterinary research product, which requires the company to carry out clinical trials to demonstrate compliance with regulatory and ethical standards.
PharmAust already completed successful tablet safety and blood level tests earlier this year and has also completed scaled manufacture of the new Good Manufacturing Practice, or “GMP”, quality tablet.
Tablet shelf-life stability tests will be finalised in mid-August before the tablets can be distributed to veterinarians for administration to dogs with cancer.
Chief Scientific Officer Dr Richard Mollard said: “PharmAust anticipates delivery of the tablets from the USA in August/September and then recruitment can commence for the Phase II trials shortly thereafter. PharmAust aims to first treat dogs with B-cell lymphoma, the most prevalent canine cancer.”
The company previously said that the trials will initially follow a 28-day treatment regimen but could be extended if pet owners request continued treatment of their pets.
Dosing of Monepantel will be based on the company’s experience with the effective level of the drug in previous cancer studies.
In May, the company said that serum levels of both Monepantel and its major metabolite, monepantel sulfone, in healthy beagle dogs given one tablet daily for nine consecutive days during the Phase 1 trials, exceeded the predicted anti-cancer activity target values.
In addition, serum levels in dogs administered five tablets daily were triple the target values while the drug remained well tolerated in all dogs at either dosing level.
Previous laboratory testing of Monepantel tablets at the Olivia Newton-John Cancer Research Institute in Melbourne demonstrated that both Monepantel and monepantel sulfone killed cancer cells while non-cancerous cells remained relatively unaffected.
Monepantel also has proven activity as an anti-parasite drug in livestock animals and has a very good safety record following years of use in that industry.
