Oncology company PharmAust (ASX: PAA) has manufactured its first batch of monepantel anti-cancer tablets in readiness for the phase I clinical trial in dogs, which will begin later this month.
The company has produced 2,000 tablets, which will meet the needs of the phase I clinical trial, which is scheduled to begin on 19 February.
To carry out the study, PharmAust executed an agreement with a major US contract research organisation.
The organisation will conduct the research, which is designed to provide information on the tablet number, administration, frequency, blood levels and safety.
“The trial design should provide the required information to enable the best possible treatment for pet owners’ dogs with cancer in the upcoming phase II trials,” PharmAust chief scientific officer Dr Richard Mollard said.
“Further, because monepantel is now in a tablet instead of a liquid, the safety component of this trial design would potentially form part of the bridging component required for regulatory authorities such as the Food and Drug Administration for establishing an investigative new drug application for clinical trials in humans,” Dr Mollard added.
According to PharmAust, monepantel is a small molecule that has already been approved for use in killing gut parasites in livestock throughout Australia, New Zealand, Uruguay and 27 European countries.
PharmAust noted it has a “good safety record” following its years’ of use in these countries.
In addition to destroying gut parasites, laboratory testing identified the molecule’s anti-cancer activity in many different cancers.
PharmAust reformulated the molecule into a drug that is suitable for treating dogs and humans with cancer in a clinic.
Although not in its new tablet form, in it’s previous liquid state, monepantel’s anti-cancer activity was validated in a small phase I human trial and a phase II study in treating canines with lymphoma.
In the canine trials six of the seven dogs treated had smaller tumours and stable disease with no “remarkable adverse events”. However, the drug’s taste was deemed poor and the dose was lower.
With the human research, four people with different cancers that had failed conventional treatments were given monepantel. Three patients revealed stable tumour size, with all patients possessing reduced monepantel anti-cancer activity markets.
Higher doses weren’t carried out, again, due to the poor taste of the liquid.
Due to canines developing similar cancers to humans, PharmAust believes domestic dogs are “excellent models of human complex diseases”.
Additionally, more than US$40 billion is spent on canine health care annually – second, only, to humans.
With more than 65 million dogs and 32 million cats in the US, around 6 million cancer diagnoses are made each year in each species.
Meanwhile, PharmAust anticipates the human anti-cancer market will be worth US$155 billion by 2025.
By mid-morning trade, shares in PharmAust had risen 4.55% to $0.046.