PharmAust’s (ASX: PAA) phase two trial evaluating its monepantel (MPL) drug in canines with B cell lymphoma has now expanded to the United States.
The expansion comes after an agreement with Pathway Vet Alliance as Thrive Pet Healthcare and Heart of Texas (HoT) Veterinary Specialty Centre in the US.
PharmAust will send sufficient MPL tablets to HoT to treat up to 10 dogs under the country’s Food and Drug Administration pilot program.
The US study builds on a new trial site in New Zealand where the first 28-day treatment of a dog with B cell lymphoma was just completed.
Meanwhile, trial recruitment is continuing in Australia, with PharmAust noting it had successfully filled interim phase two endpoints.
To-date, 25 dogs have been treated using MPL monotherapy, and have continued to display “positive outcomes”.
“One aim of expanding the study sites is to accelerate the enrolment of case numbers required to enable PharmAust to close out the phase two study as quickly as possible,” PharmAust trial principal investigator Kim Agnew explained.
PharmAust chief scientific officer Dr Richard Mollard said the company looked forward to completing the phase two trial in the “near future”.
Combination therapy successful
In addition to evaluating MPL as a monotherapy, eight dogs have been treated post-trial using an ongoing combination of MPL and prednisolone.
Prednisolone is the current standard of care for treating this form of lymphoma.
“The combination of MPL and prednisolone post-trial to-date is doubling average and medium survival times compared to prednisolone alone, enabling a greater number of trial arm options to be prepared for a registration trial,” Dr Mollard noted.
Using MPL and prednisolone has provided average survival times of 140 days or 20 weeks.
PharmAust noted this compares favourably with the eight-to-nine week average survival time for B cell lymphoma canine sufferers that are treated with prednisolone alone.
“Furthermore, high qualities of life for dogs and their owners have been reported on this combination treatment,” the company added.