Hopeful news for dogs in Australia. Maybe the research and clinical trials will prove fruitful and will make their way here.

From Small Caps

By

Lorna Nicholas

February 7, 2019

Oncology company PharmAust (ASX: PAA) has manufactured its first batch of Monepantel anti-cancer tablets in readiness for the phase I clinical trial in dogs, which will begin later this month.

The company has produced 2,000 tablets, which will meet the needs of the phase I clinical trial, which is scheduled to begin on 19 February.

To carry out the study, PharmAust executed an agreement with a major US contract research organisation.

The organisation will conduct the research, which is designed to provide information on the tablet number, administration, frequency, blood levels and safety.

“The trial design should provide the required information to enable the best possible treatment for pet owners’ dogs with cancer in the upcoming phase II trials,” PharmAust chief scientific officer Dr. Richard Mollard said.

“Further, because Monepantel is now in a tablet instead of a liquid, the safety component of this trial design would potentially form part of the bridging component required for regulatory authorities such as the Food and Drug Administration for establishing an investigative new drug application for clinical trials in humans,” Dr. Mollard added.

Monepantel

According to PharmAust, Monepantel is a small molecule that has already been approved for use in killing gut parasites in livestock throughout Australia, New Zealand, Uruguay and 27 European countries.

PharmAust noted it has a “good safety record” following its years’ of use in these countries.

In addition to destroying gut parasites, laboratory testing identified the molecule’s anti-cancer activity in many different cancers.

PharmAust reformulated the molecule into a drug that is suitable for treating dogs and humans with cancer in a clinic.

Although not in its new tablet form, in its previous liquid state, Monepantel’s anti-cancer activity was validated in a small phase I human trial and a phase II study in treating canines with lymphoma.

In the canine trials six of the seven dogs treated had smaller tumours and stable disease with no “remarkable adverse events”. However, the drug’s taste was deemed poor and the dose was lower.

With the human research, four people with different cancers that had failed conventional treatments were given Monepantel. Three patients revealed stable tumour size, with all patients possessing reduced Monepantel anti-cancer activity markets.

Higher doses weren’t carried out, again, due to the poor taste of the liquid.

Development strategy

Due to canines developing similar cancers to humans, PharmAust believes domestic dogs are “excellent models of human complex diseases”.

Additionally, more than US$40 billion is spent on canine health care annually – second, only, to humans.

With more than 65 million dogs and 32 million cats in the US, around 6 million cancer diagnoses are made each year in each species.

Meanwhile, PharmAust anticipates the human anti-cancer market will be worth US$155 billion by 2025.

 

[Here’s another article on the drug Monepantel from StockHead

PharmAust has made 2000 anti-cancer pills that it really hopes dogs won’t gag on

Oncology company PharmAust (ASX: PAA) is finally ready to go large on testing its monepantel anti-cancer tablets on dogs.

PharmAust (ASX:PAA) has had the green light to test its doggy cancer pill since April last year.

It certainly looks like it might work – recent studies showed that in both humans and dogs, the de-worming drug monepantel not only had a cytotoxic effect on cancer cells, it also metabolised to monepantel sulfone.

That metabolite, they found, remained in the body for some time, where it appeared to have the same effect on cancer cells. Just as importantly, it had the same non-toxic effect upon non-cancer cells as monepantel.

That led the team from Olivia Newton-John Cancer Research Institute to say PharmAust’s pills were predicted to “provide an enduring and specific effect through a ‘double kick’ to cancer cells while minimally affecting normal cells in the body”.

All good so far.

The bad news since April has been that it appears dogs would rather die than eat it, because it tastes awful.

And once dogs eat something they don’t like – amazing as it is that such a thing exists – they rarely eat it again.

Some adjustments were made. At the end of 2018, a less vile tablet was formulated. And in January, a new “excipient formulation” resulted in the dogs having to eat less pills.

Excipients are agents included in tablets that help shape or dissolve the tablet but are not the active ingredient itself. Adjusting it meant PharmAust could get twice the amount of monepantel into a single pill.

Now it’s got that right, PharmAust has 2000 less-vile, more powerful pills ready for canine testing in a Phase I clinical trial starting February 19.

A US research team will look to:

• determine whether monepantal works better on a full or empty stomach
• confirm monepantel’s safety at single dose in a dose escalation study
• determine how often a dosage is required to achieve blood levels that could be compatible with anticancer activity; and
• establish a 28 day repeat dose drug level study in prepapration for Phase II studies on dogs with cancer.

Ultimately, PharmAust wants to establish whether monepantel is safe and effective for human use.

But there is certainly a big market for dogs. In the US alone, about 6 million poor doggos a year are diagnosed with cancer, and spending on their health is second only to spending on human health.