PharmAust is basking in the early success of Phase I clinical trials for its flagship anti-cancer drug Monepantel in dogs. Preliminary results show that the blood concentrations of Monepantel in the test subjects already exceeded levels observed to achieve anti-cancer activity after administrating just one tablet. The company has now started the dose escalation component of the Phase I trial on schedule.
The success of biotech companies revolves around clinical studies, and if the preliminary results of the Phase I clinical trials for PharmAust’s flagship anti-cancer drug Monepantel in dogs are any indication, then the sun is on the rise for the ASX-listed company.
Following a single dose administration of one tablet to dogs, blood concentrations of Monepantel exceeded those observed in the previous Phase I clinical trial in humans, which were associated with reduced tumour marker levels in the blood.
Notably, the serum concentrations from this single dose already exceed levels that were observed to achieve anti-cancer activity in mice bearing human cancer xenografts.
Management said that as noted with the earlier prototype tablets, achieving these concentrations was dependent upon the dietary setting where the tablet is preferentially taken during or after a meal.
PharmAust’s new tablet formulation for Monepantel was given the tick of approval by a group of beagles which readily took prototype tablets either directly from administrators’ hands or the floor during recent testing.
With the positive preliminary data now to hand, the company has started the next dose escalation component of the Phase I trial on schedule.
Chief Scientific Officer Dr Richard Mollard said: “This preliminary data set provides early evidence that a single dose of PharmAust’s monepantel tablets can provide sufficient drug levels in serum to achieve anti-cancer activity.”
“This is a pleasing result as it means dosing of canines by their owners will be much less of a challenge using these tablets. PharmAust will next investigate dose escalation and repeat dose administration to align long term administration frequency with these same blood levels, anti-cancer activity and the very good safety setting established for this drug.”
Laboratory testing of Monepantel tablets manufactured using the new process at the Olivia Newton-John Cancer Research Institute, or “ONJCRI”, in Melbourne, demonstrated the drug’s ability to kill cancer cells without affecting non-cancerous cells.
This result is a major leap forward in an industry where many cancer-fighting methods tend to take out the good cells with the bad.
Research by ONJCRI has also demonstrated that Monepantel’s principle end-product, metabolite Monepantel Sulfone, retains the same biological activity as the drug itself, providing enduring and specific effect through a “double kick” to cancer cells.
Whilst it is still early days for PharmAust, the preliminary results suggest that the successes it enjoyed in the laboratory have now carried over to live dogs.