PharmAust’s Phase-2 trial of canine B-cell Lymphoma has demonstrated that dogs are living longer than expected when treated solely with Monepantel (MPL) – a novel and safe inhibitor of the mTOR pathway.

A 13-year-old Beagle, Louie, has surpassed one year after being treated only with MPL, and showing no side effects.

PharmAust (ASX:PAA) says Louie was diagnosed with Progressive Disease (PD) at the end of his 28-day trial and the prognosis was “poor”, but has since achieved >365 days of good quality of life.

“It appears that dogs given MPL + prednisolone (or, in Louie’s case, MPL on its own) after the 28-day trial period are living three times longer than expected with good quality of life and no chemotherapy-related side effects,” the company said.

Lymphoma in dogs

B-cell Lymphoma in dogs has a poor prognosis and without treatment, many types of lymphoma are fatal within a few weeks.

Even though chemotherapy can offer extended survival (typically around 12 months), it is only palliative and often results in an unacceptable adverse events profile and substantial costs.

The life expectancy of dogs with B-cell Lymphoma, treated with the standard of care (palliative steroid therapy) typically provides for 42-56 days of survival in association with progression.

PAA says the combination of MPL with prednisolone has extended median survival to these pet dogs of 150 days. More importantly, owner surveys from dogs in the trial indicate an excellent quality of life (QoL) score feedback.

Lymph nodes shrunk 20pc after two weeks on MPL tablets

Louie was diagnosed with lymphoma and given 4-8 weeks to live.

After taking Monepantel tablets for two weeks, it was found that Louie’s lymph nodes had shrunk 20% and there were no side effects from the drug.

Louie’s owner Iain Gibson said Louie still enjoys his walks and “can still manage a decent pace” while sniffing everything in his path.

“Mealtimes are Louie’s favourite part of the day and his second favourite thing is cuddles,” said Gibson said.

“Louie also attends doggy day-care two days a week and loves to chill out with his pack at home, quite happy doing nothing as long as he has someone to do nothing with.”

PharmAust repurposing MPL as an effective cancer treatment  

MPL is already approved for veterinary use for a different indication in food-chain animals and PAA is endeavouring to repurpose MPL as a safe and effective cancer treatment without the associated side effects of chemotherapy.

Principal investigator Dr Kim Agnew said despite Louie being with Progressive Disease at Day 28, the ongoing MPL therapy had helped to stabilise further development of the lymphoma since that time.

“The tumour development slowed and, despite Louie still having evidence of lymphoma, his energy and quality of life remain excellent,” she added.

Looking ahead

PharmAust’s commercial strategy is to take the middle ground in the treatment of B-cell Lymphoma which is achieved by inducing stable disease for 4-6 months with minimal side effects, so that the family and the dog can enjoy the limited time together.

“The trial is 100% the best decision that we could have made for Louie,” Gibson said.

“He deserved a break after the other issues with his knees and spleen he’s had over the years.

“We’ve so enjoyed this extra time we’ve had with Louie and hoping that his eventual passing won’t be quite so painful as a result of this extra time.”

Potential Corporate Outcome on MPL Vet anti-cancer application

Pet ownership has dramatically increased with 62% of all Australians now owning at least one pet. Pet humanisation and premiumisation is driving an increase in spend on pet services and pet needs.

The oral therapeutics market in pets is expected to be US$359 million in 2032.

The highly marketable condition of progression-free-survival in canines as an outcome from trials as well as recurring revenues from commercialisation of MPL for canines is an attractive partnership for big pharma.

PharmAust believes this product concept fills the major gap between untreated animals and chemotherapy. The market for MPL in canine cancer could be in the region of US$50m+pa.

Phase 2 results in B-Cell Lymphoma have shown MPL to be a very safe drug that promotes a high quality of life during treatment, as well as being able to offer progression free survival as a registration end-point. The fact that MPL can act as a cancer suppressor with the potential to be taken for long periods of time at high doses, presents a previously unmatched recurring revenue outcome for a licensing partner that should command a higher premium.

PharmAust in advanced confidential discussions with potential licensing partners for canine cancer. The negotiations to date are consistent with the Company’s strategy of the licensing or sale of MPL’s vet cancer applications following commercially valuable Phase 2 outcomes.

A licensing deal would enable PharmAust to facilitate MPL’s veterinary cancer application while helping fund future human trial in cancer and neurodegenerative diseases. There would be potentially a handsome future royalty income to PharmAust from MPL sales in canines.

Pic: Supplied




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


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