PharmAust (ASX:PAA) has announced an agreement with Pathway Vet Alliance dba as Thrive Pet Healthcare and Heart of Texas (HoT) Veterinary Specialty Centre in the US to join the monepantel (MPL) pet dog B cell lymphoma trial.
PharmAust said it will send sufficient tablets for HoT to treat up to 10 dogs according to FDA pilot program guidelines.
It said the US expansion builds on its 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 also continues in Australia with PharmAust successfully fulfilling interim Phase 2 trial endpoints. 25 pet dogs have now been treated using MPL monotherapy.
PharmAust said it 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," it said.
Trial principal investigator Kim Agnew said, “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. 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 added “PharmAust is delighted to be working with the Heart of Texas Veterinary Speciality Centre to enrol pet dogs for this trial in the USA. We look forward to the successful completion of the Phase 2 trial in the near future. 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.”