PharmAust is a clinical-stage company developing novel targeted cancer, neurodegenerative and antiviral therapeutics for humans and cancer therapeutics for animals. PharmAust is repurposing marketed drugs, lowering the risks and costs of development.
Dr Roger Aston, Executive Chairman
PharmAust (PPA) is a clinical-stage company developing therapeutics for both humans and animals.
The company specialises in repurposing marketed drugs lowering the risks and costs of development.
PAA’s lead drug candidate is monepantel (MPL), a novel, potent and safe inhibitor of the mTOR pathway – a pathway having key influences in cancer growth.
MPL has been evaluated in Phase 1 clinical trials in humans and Phase 1 & 2 clinical trials in dogs. MPL treatment was well-tolerated in humans, demonstrating preliminary evidence of anticancer activity.
MPL treatment was well tolerated in dogs and the trials demonstrated objective anti-cancer activity and objective clinical benefits in dogs with treatment naïve B Cell lymphoma. Details of the trial and trial centres can be found on the company website at: https://www.pharmaust.com/petdogtrial/
Phase 2 to 3 Bridging Trial Currently Recruiting
The MPL trial is ongoing and currently transitioning from Phase 2 to Phase 3. Finalisation of dosing optimisation is almost complete, and investigating MPL in combination either with prednisolone or CHOP-based protocols is also possible at selected centres.
The trial involves treatment at home with a consultation at the dog’s nearest trial centre, listed below. Basic Inclusion and Exclusion criteria are also listed. Trial centre veterinarians will provide greater detail about enrolment and the nature of the trial. L- asparaginase, vincristine, cyclophosphamide, prednisolone, and doxorubicin.
More about Monepantel (MPL)
MPL is already approved for veterinary use for a different indication and species. MPL is a very safe drug with very minimal side effects. PharmAust is aiming to repurpose MPL as an approved, effective and alternative cancer treatment.
Currently, the ”gold standard” treatment option for B Cell lymphoma is chemotherapy, which can come with several limitations and adverse events, and unfortunately, relapse can occur within six to 12 months post the chemotherapy treatment
Monepantel has a different mode of action to chemotherapy which means treated dogs do not exhibit the same side effects which can be observed during chemotherapy in dogs. It also has the advantage of being able to be administered at home using a palatable table given daily.
Dr Kim Agnew, Principal Investigator of the MPL trial
Veterinary Trial Centres
The following veterinary trial centres have been set up to evaluate MPL in dogs that have been newly diagnosed with treatment naïve (not undergone any treatment) B cell lymphoma:
Dr Sonya Yu: Animal Referral Hospital, Homebush, Sydney NSW (02) 9758 8666
Dr Kathleen O’Connell: Animal Referral Hospital, Sinnamon Park, Brisbane, QLD (07) 3172 0593
Dr Catherine Chan: Veterinary Specialist Services, Jindalee, Brisbane, QLD
1800 442 648
Dr Sue Bennett: Western Australian Veterinary Emergency and Specialty (WAVES), Success, Perth, WA (08) 9412 5700
Dr Jessica Finlay: Perth Veterinary Specialists, Osborne Park, Perth, WA (08) 9204 0400
“So far, the initial trials in pet dogs with B Cell lymphoma have proven successful,” said Dr Agnew. “We were pleased to see that in the first trial using the original liquid formula, six of seven dogs achieved stable disease over a prescribed 14-day trial period, with six of seven dogs also showing reductions in their tumour sizes. In ongoing investigations, we have better defined an optimal dose and focused on the outcomes of disease progression and the quality of life of the pet during treatment. PharmAust has observed dogs treated at the optimal dose enjoying a good extension and high quality of life after the trial with an ongoing treatment of monepantel in combination with prednisolone over 18 -24 weeks. This is more than twice as long as expected from prednisolone alone.”
No safety issues, improved taste
No safety issues were encountered in the first trial; however, the drug formula had a particularly unpleasant taste. So, the drug was reformulated from liquid to a more convenient and very easy-to-swallow tablet.
“This tablet completely resolved the taste problem and allowed us to significantly increase the dose being given in a second Phase 2a trial,” said Dr Agnew.
“From the trials, using this tablet we were able to identify an optimal dose where anti-cancer activity was maximised. At this dose, one dog’s external lymph node measurements reduced by over 60 per cent and other dogs have exhibited cancer stabilisation combined with good quality of life during this treatment period. It is this dose that have almost finalised during the Phase 2 to 3 bridging trial.”
Dr Kim Agnew
Which dogs with lymphoma are eligible?
To participate in these trials, dogs can have any stage of lymphoma but must be feeling generally well.
Ultimately, the patient will only be given the treatment if they have B cell lymphoma but immunophenotyping (analysis of whether the cancer is a B cell or T cell type) is covered as part of the initial screening.
The dog entry criteria for the new clinical trial program are:
- Any stage of lymphoma (based on physical exam)
- Substage A (feeling well)
- Immunophenotype can be pending but must be submitted, and needs to be B Cell based on clinical characteristics
- No previous treatment in the previous 8 weeks, including corticosteroids (prednisolone)
- No other significant concurrent medical problems
- Good quality of life
- The dog should weigh more than 11 kg.
Ruby & Ryley’s Stories
Read testimonials from both Ruby and Ryley’s owners in our Testimonial Tab.
Discover more by visiting the PharmAust Australia website www.pharmaust.com
Ruby is our 12-year-old, black and tan Cavalier King Charles Spaniel. She is just the sweetest, gentle girl.
We got Ruby as a mate for our other Cavalier, Lily. They were inseparable, bringing us so much joy and laughter. Besides loving food and sneaking off to steal some of our cat’s dinner, Ruby just spends her time loving on everyone and snuggling up to me.
Ruby was diagnosed with B-cell lymphoma in June 2022 by our local vet at Chelmer Graceville Vets after my daughter Ella found lumps under Ruby’s jaw. She had no other symptoms. This diagnosis was confirmed by Dr Kathleen O’Connell at Animal Referral Hospital (ARH) in Brisbane.
After our consultation and investigation with ARH, I was given two pages of possible treatments. Dr O’Connell discussed the possibility of the Monepantel (MPL) trial over the phone as I was home sick with Covid. I did some research about MPL and found Ryley and Chica’s testimonials which made me feel more comfortable about the trial.
I decided to do the trial as I felt that with her age, pancreatitis issues and thyroid issues, chemotherapy would be too much for Ruby. The Monepantel trial would allow us to have longer with her and with good quality of life, which was very important to me.
So far, our experience on the trial has been very positive. We have been delighted to get an extra four months with Ruby. She still enjoys doing much of what she previously did, albeit a little slower, but she has no health issues since being on the trial and the team at ARH have been wonderful.
Each month that we pop in for her check-up we can’t believe that another month has passed, and we still get to have her in our lives. I try and tell everyone about this trial because I think it is so valuable and is another option that is more cost effective for the average person.
Ryley is our 5-year-old Border Collie x Kelpie. She is friendly, energetic, loyal, obedient, intelligent and inquisitive. She got her name from the country town where she was born – Rylestone.
Ryley is our companion and the reason why we go for walks or runs, even when we don’t feel like it. She loves chasing waves, playing tug of war with her fluffy and squeaky toys, chewing large bones and burying them around the yard, exploring hidden places and greeting everyone walking past our house by racing up and down the fence line.
Ryley was diagnosed with B-cell lymphoma in July 2021 by our local vet. My husband was giving Ryley a pat and noticed a few lumps on her neck. We had also heard her coughing a few times. When we took her to our vet at Burwood Road Veterinary Clinic, we never thought it was anything serious, as she never seemed unwell. She had her usual appetite and energy levels.
We were amazed when our vet said it was lymphoma and that her life expectancy was weeks to months. It was confronting to have that diagnosis. We didn’t want to put her through anything drastic, which would make her more unwell and affect her quality of life. We felt that chemotherapy was not an option as life expectancy is still not much more than 1 year. Our main aim was to hopefully extend her life, but more importantly maintain her quality of life.
We immediately started researching clinical trials and found Dr Sonya Yu (Animal Referral Hospital), who is involved in the MPL Trial. I am a nurse with some experience in clinical trials, so I had a bit of an idea of what I thought would be a suitable trial. This trial guaranteed that she would actually be on the medication – not a placebo – and it didn’t involve an excessive amount of invasive investigations and clinic visits.
The MPL trial has been a positive experience for us. Dr Sonya is fantastic and has been wonderfully supportive to Ryley and us. It’s been easy to give Ryley two tablets a day and fortunately we live quite close to the Animal Referral Hospital, so it’s been easy to take her for the visits.
Our GP vet was also supportive of the trial, and it felt reassuring to do something.