PharmAust Limited (ASX: PAA) has reached an agreement with Pathway Vet Alliance dba as Thrive Pet Healthcare and Heart of Texas (HoT) Veterinary Specialty Centre in the USA to join the MPL pet dog B cell lymphoma trial.
PharmAust will send sufficient tablets for HoT to treat up to 10 dogs according to FDA pilot programme guidelines.
This US expansion builds on PharmAust’s new trial site in New Zealand. The New Zealand site recently completed its first 28 day treatment of a dog with B cell lymphoma for a successful trial outcome.
Trial recruitment continues in Australia with PharmAust successfully fulfilling interim Phase 2 trial endpoints. 25 pet dogs have now been treated using MPL monotherapy.
With continued positive outcomes, PharmAust is preparing for a successful Phase 2 completion and the commencement of a subsequent registration trial.
In addition to the trial MPL monotherapy, eight dogs have now been treated post-trial using ongoing MPL in combination with standard of care prednisolone. This MPL and prednisolone combination has to date provided median and average survival times of approximately 140 days or 20 weeks. This compares favourably with the eight to nine week median and average survival times expected for dogs with B cell lymphoma treated with prednisolone alone.
Furthermore, high qualities of life for dogs and their owners have been reported on this combination treatment.
One aim of expanding the study sites is to accelerate the enrolment of case numbers required to enable PharmAust to close out the Phase 2 study as quickly as possible,” Trial Principal Investigator Kim Agnew said.
“The HoT and Pathways teams have been great to work with during the study planning phase, and we are excited to bring Monepantel for canine lymphoma to the US for the first time.”
PharmAust’s Chief Scientific Officer, Dr Richard Mollard, said 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.
