Six dogs have completed PharmAust’s (ASX: PAA) phase IIb trial evaluating its lead drug monepantel (MPL) in the most prevalent cancer in canines B-cell lymphoma.
During the March quarter, PharmAust revealed six dogs with stage four to five B-cell lymphoma had completed evaluation across five trial sites.
However, one dog was not in compliance with the trial process and was subsequently withdrawn.
PharmAust noted the remaining dogs’ side-effects were less than conventional anti-cancer drugs, with only occasional inappetence reported.
The company said this occasional side effect “appeared insignificant” and was difficult to attribute solely to MPL.
Post-trial the owners have continued with MPL on a compassionate use basis.
Interim analysis has provided “further supportive evidence” that MPL blood plasma was at the level required to suppress B-cell lymphoma growth in canines.
“PharmAust is now in a good position to further optimise treatment levels of MPL to facilitate design and execution of a phase II study,” the company stated.
The company’s strategy is to discuss veterinary collaborations and identify optimal cancers to target commercially with MPL.
Additionally, animal healthcare companies in the US and Germany have shown interest and have approached PharmAust for discussions.
Human cancer trials
As canine trials continue to advance, PharmAust is taking “key steps” to evaluate MPL in human studies.
To progress these, PharmAust has begun engaging with pharmaceutical companies to discuss human collaborations and the best cancers to target with MPL.
The company has identified suitable clinical oncology units in the UK and Italy. These will likely be used to evaluate the new MPL tablets in a phase II trial.
A previous study had demonstrated tumour suppression and prevention of progression but was stopped early due to the unpalatable nature of the liquid MPL formula used.
Since then, PharmAust has since reformulated the drug into a tablet which resolves the palatability issues.
A phase II trial in human cancers is scheduled to begin in the first quarter of next year.
MPL in SARS-CoV-2
During the March quarter, PharmAust continued pre-clinical work, which identified that MPL has a possible antiviral impact on SARS-CoV-2 – the virus behind the COVID-19 pandemic.
In readiness for a phase I clinical trial in humans, PharmAust has developed an executive summary and is preparing an investigator’s brochure.
The company has also been engaging with clinicians in the US and Eastern European and Caucasus countries and the Balkans.
GMP-quality MPL production has already begun at a facility in India and remains on track despite the country’s massive COVID-19 outbreak.
Not stopping at cancer and COVID-19, PharmAust will also evaluate its MPL in motor neurone disease (MND).
The company secured a $881,085 grant from Australia’s largest independent funder of MND research FightMND.
Funds will be used in a phase I trial with preparations already underway. It is expected the trial will begin in the December quarter.
Meanwhile, PharmAust’s subsidiary Epichem has continued to chase opportunities to build its own IP portfolio, which includes a novel waste to fuels technology.
Epichem’s research and development along with PharmAust’s other subsidiary Pitney Pharmaceuticals’ work has resulted in a $755,594 research and development rebate.
All up, PharmAust ended the March quarter with $3.94 million in cash, which it says is adequate to fund its current activities.