Pharmaust will complete preliminary clinical trials on dogs in the coming weeks to help determine the required dosage for its newly reformulated Monepantel tablets and to confirm that it is non-toxic. The company will also start a Phase I “pharmacokinetic study” with the new tablets during the fourth quarter and it will also follow this up with initiation of its long awaited Phase II clinical trials.
ASX listed biotech Pharmaust, will complete preliminary clinical trials on dogs in the coming weeks to help determine the required dosage for its newly reformulated Monepantel tablets in canine subjects.
Data from the canine trials will help determine the required doses for humans and confirm the non-toxic profile of Pharmaust’s very promising anti-cancer drug Monepantel.
The latest trial will also determine if there are any food associated effects on absorption of the drug into the blood stream and provide potential manufacturers with advice about how compact the tablets need to be.
PharmAust will start the Phase I pharmacokinetic study with the new tablets during the fourth quarter and will follow this with initiation of the Phase II clinical trial.
The company is also completing several optimisation steps required to scale up the manufacture of tablets in accordance with the “Good Manufacturing Practice”, or “GMP” standards.
Whilst GMP manufacturing standards are not required by regulatory authorities for early stage clinical trials, producing the tablets to the highest possible safety standards will help accelerate product development the company says.
In addition, data collected from these studies will be valuable for registration studies by partners.
PharmAust recently reformulated Monepantel into tablet form and made it more palatable for man’s best friend.
Previous testing of Monepantel in dogs with lymphoma successfully achieved safety and effectiveness goals with six out of seven dogs achieving stability of disease and even a reduction in tumour size.