PharmAust is preparing for a successful Phase 2 completion

PharmAust has hit another milestone in its moves to find a better treatment for dogs with cancer using its lead drug Montepantel (MPL).

PharmAust (ASX:PAA) has announced two dogs have had a partial response (latest dog confirmed yesterday) as assessed by the administering veterinarians. Partial response is a decrease in tumour size (sum of longest diameter as defined by RECIST criteria) of >30%, no new lesions.

Veterinary trial centres have been established in Australia, New Zealand and the US to evaluate the anti-cancer benefit of MPL in dogs newly diagnosed with B-cell lymphoma with two new dogs recently recruited.

PAA is recruiting pet dogs with untreated B-cell lymphoma to finalise the Phase 2 evaluation of the drug MPL, which has demonstrated effective anti-cancer activity and minimal side effects.

So far 33 dogs have been treated using MPL monotherapy (excluding four dogs removed from the study).

With continued positive outcomes, PAA is preparing for a successful Phase 2 completion and the commencement of a subsequent Phase 3 registration trial.

Side effects in the trial have been minimal or not detected. In comparison, the most common side effects of a dog being treated with chemotherapy include gastrointestinal effects, such as vomiting, diarrhoea or loss of appetite and decreases in blood cell counts.

Also, during chemotherapy, owners need to take precautions when handling their pets and their waste.

Drugs may be excreted in the urine and faeces, so it is not advisable for children to play with their pets for the duration of therapy.

PharmAust requires greater than or equal to 18 dogs with an overall clinical benefit out of 46 dogs to meet its statistical endpoint.

Outcome aim to improve quality of life

Results to date have shown that dogs treated with MPL have 2.5 to 3 times the life expectancy than the current standard of care (palliative steroid therapy) that typically provides for 6-8 week survival in association with a range of adverse events.

PharmAust recently reported that two dogs lived for 191 days on MPL + prednisolone which is an outstanding result. Furthermore, the dog’s owners have reported increased quality of life of their pets after using the combination treatment. Median survival time for dogs in the PharmAust trial is 153 days.

In dogs treated with MPL/Prednisone as ongoing therapy after MPL alone, Progressive Disease (PD) outcomes at D28 don’t appear to be associated with poorer clinical outcomes and/or shorter overall survival times over the life of the dog.

PAA said no matter the treatment protocol, most dogs with lymphoma will die from it.

Stabilisation (as opposed to regression) of lymphoma with good quality of life is an excellent outcome.

Short-term priorities

PAA said its short-term priorities now centre around expanding the opportunities for collaboration for Phase 3 trial investment.

PAA is also using in-depth market and competitor research to build greater understanding of the potential new market segment that MPL can use in treating B Cell lymphoma in pets.

An estimated 6 million dogs are diagnosed with cancer each year in the US compared to 1.7 million humans.

Many of the most common cancers in dogs (eg lymphoma, osteosarcoma, mammary) are recognised as being very similar to human cancers.

As such, dogs are increasingly recognised as excellent models for human disease.

PAA’s commercial target is to develop and partner a product that supersedes the current use of Prednisolone alone and/or can reduce or replace the use of chemotherapy in dogs.

The company has received positive feedback from owners of dogs participating in the MPL trial who have said they have seen an increase in the quality of life of their pets.

Meanwhile, the Australian Taxation Office approved PAA’s application for a RDTI for FY22, with $654,109 deemed refundable on research and development undertaken by its wholly owned subsidiaries Epichem Pty Ltd and Pitney Pharmaceuticals.

This article was developed in collaboration with PharmAust, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.