ASX-listed PharmAust has kicked-off its much-anticipated Phase II clinical trials that will study the effectiveness of the new palatable and high dose tablet formulation of its Monepantel anti-cancer drug in dogs.
The company has started recruitment of pet owners with dogs suffering from B cell lymphoma – the most common canine cancer – as the initial target cancer.
This trial is expected to verify the success observed in treating canine lymphoma from an earlier short-term clinical study using the old liquid formulation that had poor palatability.
Management said the new, better-tasting tablet would enable the new study to be of longer duration, permitting the determination of efficacy over a prolonged period of time.
The company will then broaden the trial base to test for low dose maintenance of progression free survival and efficacy in other cancers.
PharmAust is also finalising agreements to expand the trial to other sites in Australia to accelerate accrual rates and enable faster trial endpoint determinations.
In May this year, testing confirmed 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 I trials, exceeded the predicted anti-cancer activity target values it was seeking.
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.
Monepantel and monepantel sulfone have also been found to kill cancer cells while leaving non-cancerous cells relatively unscathed in previous laboratory testing at the Olivia Newton-John Cancer Research Institute in Melbourne.
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