ASX-listed biotech, PharmAust, has received a shipment of Good Manufacturing Practice, or “GMP”, Monepantel tablets from the US, for its Phase II anti-cancer drug trials in dogs.
The products were delivered to the company’s subsidiary, Epichem, who will now distribute the drugs to veterinarians starting this week, to commence the Phase II studies.
According to PharmAust, the shipment of the tablets occurred after testing demonstrated that the manufactured drugs were consistent in size, shape and content.
The tablets were also shown to be stable and passed appropriate shelf-life requirements to support their performance and hence, will not be compromised under the handling conditions expected following distribution to vets and subsequently, dog owners.
PharmAust Chief Scientific Officer Dr Richard Mollard said: “PharmAust is pleased to accept delivery of the newly developed tablets on schedule at its Epichem facility. Furthermore, PharmAust is looking forward to providing these tablets to veterinarians and commencing the Phase II study, testing anti-cancer efficacy in pet dogs with B cell lymphoma.”
In July, the company received key ethics approvals from the New South Wales Department of Primary Industry to proceed with the Phase II clinical trials for Monepantel in canines.
The approval covers the investigation of Monepantel tablets for their short-term and long-term effectiveness in stabilising disease and progression-free survival or regression of cancerous tumours.
Whilst PharmAust previously secured approval to carry out the trial using the approved liquid formulation of Monepantel, the liquid proved to be unpalatable for dogs, leading the company to develop a taste-neutral tablet formulation.
The tablet formulation is a new veterinary research product, which requires the company to carry out clinical trials to demonstrate compliance with various regulatory and ethical standards.
PharmAust completed successful tablet safety and blood level tests earlier in the year and with the tablet shelf-life stability tests now finalised, it can commence trials.
The work aims to first treat dogs with B-cell lymphoma, which is the most prevalent type of 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 is based on experience with the effective level of the drug from previous cancer studies.
In May, PharmAust management 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 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 whilst 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.
Interestingly, Monepantel also has proven activity as an anti-parasite drug in livestock and has a good safety record following years of use in that industry.
The upcoming period is set to be a watershed moment for PharmAust with the company now poised to finally carry out its Phase II clinical trials of its Monepantel drug in dogs before returning to human trials at a later date.
This is starting to look interesting.
