The expansion of PharmAust’s Phase 2b studies in New Zealand is the first step towards launching a Phase 3 clinical trial of monepantel as a cancer treatment in dogs.
Clinical stage biotech company, PharmAust (ASX:PAA), is moving fast towards a Phase 3 clinical trial for canines with lymphoma, having just expanded its studies into New Zealand.
The company has signed agreements with NZ-based Veterinary Specialists Auckland and Intuit Regulatory, to expand its canine Phase 2b lymphoma studies into the country ahead of the upcoming Phase 3 trial.
The Phase 3 trial is anticipated to start in May 2022.
Specifically, PharmAust signed agreements with Dr Mike Coleman DVM, and Dr Tommy Fluen DVM.
Both are fellows of the Australian and New Zealand College of Veterinary Scientists, as well as being registered specialists in small animal internal medicine.
They both work at Veterinary Specialists Auckland, and can accept dog lymphoma referrals in New Zealand’s North Island.
Meanwhile, the regulatory and ethical compliance aspects of the trial will be overseen by Dr Julia McNab PhD of Intuit Regulatory, who has specialist expertise in Phase 3 design and registration.
Under the deal, PharmAust, along with the three experts, will seek to establish a clinical trial site in New Zealand to study the Phase 2b results in more detail, in preparation of Phase 3.
The NZ patient recruitment is anticipated to commence in December 2021.
“PharmAust is delighted to work with Dr Coleman, Dr Fluen and Dr McNab to establish a clinical trial site in New Zealand,” said PharmAust’s chief scientific officer, Dr Richard Mollard.
“Establishing trial procedures, structures and systems with these groups and receiving their feedback will provide great value to PharmAust in preparing for Phase 3, and potentially later with product roll-out.”
PharmAust’s principal investigator Dr Kim Agnew also says that it’s important to gain knowledge in new markets before the commencement of a Phase 3 trial.
“It is always very beneficial for any product development building towards a Phase 3 study to expand knowledge in new market settings, so having the NZ team combine with our team is very good for the PharmAust program,” Agnew said.
Encouraging Phase 2 results
In October, PharmAust announced encouraging results from its Phase 2 trial of monepantel (MPL) in dogs with B-cell lymphoma.
Data from Phase 2 showed that combining MPL with prednisolone more than doubles the life expectancy of pet dogs, compared with standard-of-care (prednisolone alone).
During the course of the trial, pet dogs were administered MPL as gelatin encapsulated liquid, or as a tablet.
MPL tablets were administered at four doses, and based on this, PharmAust was able to calculate an optimum drug plasma range for anticancer activity that would result in minimal side effects.
Of the seven pet dogs with drug plasma levels in the optimum range, six achieved stable disease progression, and one had a partial response with some tumours even completely disappearing.
The treated dogs have also achieved much higher than expected mean and median survival times, at 125 and 138 days, respectively.
Mollard said quality of life may be the most important outcome for pet dogs, as we don’t know how pet dogs balance expectations of their quality of life with expectations of quantity of life.
From that perspective, he said that extended overall survival time with good quality of life is the most important outcome for pet owners and veterinarians.
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.
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