ASX-listed biotech PharmAust’s has received a tidy $672,250 research and development tax refund from the Australian Government for its expenditure on the development of its flagship Monepantel anti-cancer drug.
The refund relates to the company’s successful anti-cancer clinical trials conducted in dogs with the Animal Referral Hospital in Sydney and data evaluation from completed human clinical trials with Cardinal Bio-research in Brisbane.
PharmAust’s reformulation to make a high dose tablet with improved taste, its preclinical tablet testing in rats, development of Good Manufacturing Practice grade Monepantel and aminoacetonitrile derivative analogues and its R&D collaboration program with the Olivia Newton-John Cancer Research Institute in Melbourne also contributed to the refund.
The refund will be used to advance the company’s clinical trial programs in dogs and humans.
It adds to the $2m the company raised through placement and entitlement offer to complete the Phase I and II clinical trials examining the anti-cancer activity of Monepantel in dogs with cancer.
Beagles in the trials have so far displayed no adverse effects or signs of toxicity after they were sequentially treated with either 2, 4, 7 or 10 Monepantel tablets and monitored over three days.
In addition, no apparent taste issues were noted for dogs that were administered ten tablets in one dose, highlighting the high palatability and tolerance of the new tablet formulation when compared to the previously used liquid formulation.
PharmAust has already confirmed that administering just one tablet resulted in dogs having blood concentrations of Monepantel that exceeded those observed in the previous Phase I clinical trial in humans and were associated with reduced tumour marker levels in the blood.
The single tablet dose also resulted in serum concentrations that exceeded levels that were observed to achieve anti-cancer activity in mice bearing human cancer xenografts.