PharmAust (ASX:PAA), a clinical stage oncology company, has announced that its Phase 2 dog lymphoma pilot study has successfully concluded achieving its key primary endpoints of safety and efficacy.
"Six of seven dogs diagnosed with B-cell lymphoma and treated with monepantel (MPL) developed stable disease (86%), one dog developed progressive disease (14%) and there was a median reduction in tumour size of 4%," said the company.
The objective of the trial was to assess the efficacy of its lead molecule, MPL, as a first line therapy in dogs diagnosed with B-cell lymphoma that had not received any previous chemotherapy. The dogs were treated for two weeks with daily doses of MPL as first-line therapy before commencing conventional chemotherapy. The primary endpoints were safety and clinical efficacy.
B-cell lymphoma was chosen as the target indication as it’s the most commonly treated cancer in dogs.
According to principal investigator, Dr Angela Frimberger, “We were pleased to observe that after two weeks of daily treatment with MPL alone, six out of seven dogs achieved stabilisation of their cancers, reductions in tumour sizes and no significant side-effects. This is an extremely progressive cancer; without effective treatment dogs diagnosed with lymphoma would typically show progressive disease after two weeks. So, stabilisation of disease is a positive clinical benefit according to standard criteria for measuring tumour responses.
“Furthermore, given the excellent safety margin we are seeing we expect the optimum clinical dose of the drug, once reformulated, will be substantially higher than the dose we have been using. To me, this means that monepantel has definite potential to benefit dogs with cancer and we should continue into a full clinical trial.”
PharmAust CEO, Dr Richard Hopkins, commented, “We are really pleased with the outcome to this pilot study which, according to our advisory team, strongly supports further clinical evaluation of monepantel. Monepantel will be the first mTOR inhibitor tested as a cancer therapy in dogs and has potential to address a major unmet need for new drugs in the pet cancer market.”
PharmAust added it is expecting to launch its clinical trial program using reformulated MPL in early 2018.