PharmAust has announced it will enter phase three of their trial for treatment of pet dogs with B cell lymphoma.
This follows the success of phase two in which PharmAust identified the ideal combination of monepantel (MPL, an anthelmintic drug) and prednisolone (a steroid medication) more than doubled the life expectancy of pet dogs compared with standard-of-care prednisolone.
During the trial, pet dogs have been administered MPL as gelatin encapsulated liquid or as a tablet across four doses. Based on this, PharmAust has calculated an optimum drug plasma range for anticancer activity and minimal side effects.
Kim Agnew, Trial Principal Investigator, said she was pleased with the results, and they may look to expand the study abroad.
“We have made clear progress in a short timeframe in better understanding the monepantel/B-cell lymphoma dose/response relationship and now have clearer understanding of the effective plasma range required for monepantel as a mono-therapy. It is exciting to begin planning an extension of study sites outside of Australia to explore these findings in more detail. We are actively investigating options for sites in NZ and the US to broaden enrolments.”
Of the seven dogs with drug plasma levels in the optimum range, six achieved stable disease and one had a partial response, with some tumors completely disappearing, while maintaining minimal or no side effects.
Five of the dogs that achieved stable disease continued to take MPL after the completion of the trial with all achieving a migher than expected mean and median survival time, at 125 and 138 days, respectively. All owners reported a much higher quality of life for their pet dogs while taking MPL.
Dr. Richard Mollard, PharmAust’s Chief Scientific Officer, said the trial data was proving interesting.
“Although this analysis examining the effects of combination with prednisolone is retrospective in nature, it enables the making of robust hypotheses and provides justification for their formal testing in Phase 3 studies. Quality of life may be the most important outcome for pet dogs as we do not know how pet dogs balance expectations of their quality of life with expectations of quantity of life. Extended overall survival time with good quality of life is the most important outcome for pet owners and veterinarians.”