Perth-based PharmAust (ASX:PAA), a clinical-stage oncology company, has received ethics approval from the NSW Department of Primary Industry’s Secretary's Animal Care and Ethics Committee to recommence phase 2 clinical trials in pet owners’ dogs with cancer using its newly formulated tablet.
The company previously received ethics approval for its anti-cancer program in dogs using the currently approved liquid formulation of monepantel. It said, despite demonstrating strong signs of anti-cancer efficacy, this formulation was "unpalatable" and could not be used effectively. As a result, it has developed a new taste-neutral tablet now approved for phase 2.
"Authorities consider the newly developed monepantel tablet a new veterinary research product," said the company. "As such rigorous tests to demonstrate compliance with regulatory and ethical standards have been conducted by PharmAust in recent months and include the successful tablet safety and blood level tests as announced on 6 May."
The company said the scaled manufacture of the new GMP quality tablet has been completed.
"The tablet shelf-life stability tests will be finalised mid-August and these are required before the tablet can be distributed to veterinarians for administration to dogs with cancer. Previous batches of the new tablets have passed stability testing so it is expected that this new batch will comply and then be ready to use," it said.
According to PharmAust chief scientific officer, Dr Richard Mollard, “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. PharmAust is looking forward to helping these dogs with cancer admitted to the trials.”