PharmAust has signed an agreement with US company Catalent Pharma Solutions for the GMP-grade manufacture of its “Monepantel” anti-cancer drug for its upcoming clinical trials in dogs. Manufacturing the drugs to GMP standards will enable the resultant data to be admissible to the US FDA in support of new drug registration programs, a key milestone for PharmAust.
ASX listed small cap biotech, PharmAust, has signed an agreement with US company Catalent Pharma Solutions for the GMP-grade manufacture of its promising “Monepantel” anti-cancer drug for its upcoming clinical trials on dogs.
This follows PharmAust’s development of a prototype GMP method for the scale up manufacture of Monepantel and its analogues last month.
Catalent, a USD$5.5bn company listed on the NYSE, is a global provider of drug delivery technology and development solutions for drugs, biologics and consumer health products.
It will provide scaled GMP tablet formulation for the clinical trials from its facility in San Diego.
Manufacturing the tablets to GMP standards is the key to undertaking good clinical practice trials and will enable the data from the trials to admissible to the US Food and Drug Administration to support new drug registration programs.
Initially, sufficient tablets will be made to undertake the required dose escalation Phase I study in healthy Beagle dogs.
This study will determine the numbers of tablets and the optimal frequency of administration to ensure maximum safety and provide information on the optimum dosing levels for the efficacy studies.
Initial tests on the Beagles have already determined that levels of Monepantel in the blood using just one tablet exceeded the amounts predicted to achieve anti-cancer activity from the company’s laboratory work
PharmAust will follow this with Phase II studies that will seek to confirm the anti-cancer activity of Monepantel capsules in dogs with B-cell lymphoma.
A previous study in 2017 also demonstrated that Monepantel in capsules has anti-cancer activity and no demonstrable side-effects.
Chief Scientific Officer Dr Richard Mollard said: “Commencing scale manufacture of GMP grade monepantel tablets is a tremendous milestone. PharmAust has demonstrated that the tablet prototypes can deliver a significant level of drug within the blood of healthy dogs as recently announced in our absorption study on 15th October 2018.”
PharmAust has the bit between its teeth now and is setting a blistering pace on its way towards commercialisation of this very promising anti-cancer drug.