Numbers and Mention of Phase III
PharmAust’s ongoing trials on canine cancer have returned very encouraging results. The company has expanded the study to NZ and the US.
PharmAust (ASX
AA)has announced significant progress in the canine cancer trials of its primary drug candidate, Monepantel (MPL).
Ongoing results from the trials indicate that a combination of MPL and standard of care (prednisolone) can more than double the life expectancy of dogs with cancer.
In addition, dosage refinements have potential to achieve further survival benefits for the dogs.
Following these encouraging results in Australia, and in preparation for Phase 3 registration trials, PharmAust is now recruiting canine patients in New Zealand and expects the first enrolment in the US trial site later this month.
Five dogs have already been successfully recruited in New Zealand.
“During Phase 2a and Phase 2b trials, Monepantel demonstrated effective anti-cancer activity and minimal side effects, which supports continued development into Phase 3 registration trials,” said Dr Kim Agnew, Principal Investigator of the trial.
US sites to expedite completion of Phase 2 trial
In the US, Dr Meighan Daly DeHart and the medical oncology team at the Thrive Pet Healthcare and Heart of Texas (HoT) have commenced screening and recruitment of pet dogs with B-cell lymphoma.
The trial will treat up to 10 dogs, according to FDA pilot program guidelines.
This US expansion builds on PharmAust’s trial sites in Australia and New Zealand, and was designed 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,” said Dr. Agnew.
Phase 3 registration trial in sight
In the Phase 2 trials conducted to date, 27 pet dogs were treated using MPL monotherapy.
Of the 16 pet dogs with optimum blood levels, 13 have achieved stable target lesions. This includes one dog with a partial response (60% regression).
Nine of the 16 dogs with optimum blood levels have achieved stable disease by RECIST (Response Evaluation Criteria in Solid Tumours). Side effects were minimal or not detected.
PharmAust requires greater than or equal to 18 dogs with a clinical benefit out of 46 dogs to meet its statistical endpoint.
Post-trial, some vets and the respective pet owners elected to continue the MPL treatment and, sometimes, in combination with prednisolone.
“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 that typically provides for 6-8-week survival in association with a range of adverse events,” said Dr. Agnew.
Dr. Agnew added that pet dogs treated during and after the trial at this optimum level experienced a high quality of life with minimum adverse events.
With continued positive outcomes, PharmAust is now preparing to take the study to a successful Phase 2 completion, and the commencement of a subsequent Phase 3 registration trial.
Commercial opportunities
PharmAust is currently in confidential exploratory discussions with a leading global pharmaceutical company to co-develop and commercialise MPL for the treatment of veterinary cancers.
Typically, a licensing deal involves an upfront cash payment, plus remuneration of costs spent on developing the drug which would now be around $20m—$25m, as well as a 10-12% royalty on all sales of the drug.
Such a deal would mark a significant commercial outcome for PharmAust, and see it more than fully funded for all foreseeable future clinical trials.
Dialogue is continuing, and the company will also seek input from these potential licensing partners in preparation for the Phase 3 registration trial.
“The commercial target is to develop and partner a product that supersedes the current standard of care (prednisolone),” said Dr. Agnew.
“This is to provide a canine lymphoma treatment option that can be administered daily by the owner and enabling excellent quality of life for the dog during treatment.”
MPL is already approved for veterinary use for a different indication in food-chain animals.
PharmAust is endeavouring to repurpose MPL as a safe and effective cancer treatment without the associated side effects of chemotherapy.
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