PharmAust’s MPL trials show doubled life expectancy for dogs with cancer
PharmAust has begun the screening and recruitment process to expand its canine study to the US.
The latest results from PharmAust’s (ASX: PAA) canine trials have revealed that a combination of the company’s lead drug candidate monepantel (MPL) and standard of care can more than double the life expectancy of dogs with cancer.
In addition, the clinical-stage biotechnology company believes further dosage refinements could have the potential to achieve an even better survival benefit.
PharmAust has set up veterinary trial centres in Australia, New Zealand and the United States to evaluate the anti-cancer benefit of MPL in dogs newly diagnosed with B-cell lymphoma which have not received any previous cancer treatment.
Principal investigator Dr Kim Agnew said MPL demonstrated effective anti-cancer activity and minimal side effects during phase 2a and 2b trials.
Then post-trial, some vets and respective pet owners chose to continue treatment with MPL, and sometimes, in combination with prednisolone, which is considered a standard pain relief treatment for dogs with cancer.
“The combination of MPL with prednisolone, which has provided average extension of survival to these pet dogs of 16-24 weeks, more than doubles the life expectancy than standard of care (palliative steroid therapy) that typically provides for six-to-eight-week survival in association with a range of adverse events,” Dr Agnew said.
“Pet dogs treated during and after the trial at this optimum level experienced a high quality of life with minimum adverse events,” he added.
Current trial
MPL is already approved for veterinary use for a different indication in food-chain animals, although PharmAust is seeking to repurpose the drug as a safe and effective cancer treatment without the associated side effects of chemotherapy.
The company is preparing for a successful phase two completion after a total of 27 pet dogs have been treated using MPL monotherapy, and will commence a subsequent phase three registration trial.
Of 16 pet dogs with optimum blood levels, 13 were reported to have achieved stable target lesions. The company requires greater than or equal to 18 dogs with a clinical benefit out of 46 dogs to meet its statistical endpoint.
US expansion
PharmAust has also commenced the screening and recruitment of up to 10 pet dogs with B-cell lymphoma in Texas, in accordance with US Food and Drug Administration (FDA) pilot program guidelines.
This US expansion will build on the company’s trial sites in Australia and New Zealand. Dr Agnew said one aim of expanding the study is to speed up the enrolment of case numbers required for PharmAust to close out the phase two study.
“The Heart of Texas (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,” he said.
PharmAust is expected to seek input for the canine cancer registration (phase three) trial from potential licencing partners.
The company also revealed it is in confidential “exploratory” discussions with a leading global pharmaceutical company to co-develop and commercialise MPL for the treatment of veterinary cancers.