PharmAust Commences Next Clinical Phase of Monepantel Anti-Cancer Trial for Pet Dogs in New Zealand
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MPL treatment stabilises B cell lymphoma and can make lesions disappear
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Significantly prolongs life and provides excellent quality of life for trial pet dogs during therapy
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Safer than chemotherapy; don’t have to wear gloves or keep the kids away
To date, pet dogs treated with the B cell lymphoma drug Monepantel (MPL) in Australia have enjoyed a high quality of life and significant anti-cancer outcomes while on trial.
Following this success and to prepare for a trial to formally register MPL as an anti-cancer drug in pet dogs, PharmAust is now also conducting this clinical trial in New Zealand while completing late-stage preparations to similarly incorporate sites in the United States.
Data from Phase 2 clinical trials to date have shown that MPL treatment stabilises B cell lymphoma, can make some lesions disappear, prolongs the life of treated pet dogs and can provide a high quality of life for the pet dogs.
Additionally, after the completion of the 28-day clinical trial period, and following consultation with their veterinarians, some owners have asked to continue the treatment of their pet dogs with monepantel in combination with standard-of-care prednisolone.
To date, we have been pleased to support the continued treatment of eight dogs with this combination and see average life expectancy more than quadruple compared to untreated dogs and increase 2.5 times compared to dogs treated with standard-of-care prednisolone alone.
Safe and easy to take-at-home tablet
We spent some time developing a safe and easy to take-at-home tablet for pet owners. At the recommended optimum dose, we see minimal side effects that might be attributable to MPL, with only some weight loss of approximately 2% being reported for some dogs over the 28-day trial period.
The owners of pet dogs that continue on combination treatment with prednisolone really do not report any side effects even after 6 months. Normally one might expect some side effects from prednisolone alone, so this combination is very interesting and something we will follow up on formally in the next trial.
MPL is safer than chemotherapy treatment
Currently, the best-indicated treatment option is chemotherapy, which comes with its own set of limitations and adverse events, and unfortunately, relapse can occur within six to 12 months.
Chemotherapy is toxic with many potential safety concerns for people who handle, give or are exposed to the drug. Pet owners must wear gloves when administering to their dogs and it is often recommended to keep children away from their pets for sometimes even up to 5 days after each treatment.
In comparison, MPL is very safe and dog owners do not have to wear gloves or keep their children away following treatment. It is a very interesting alternative, not only minimising side effects but also maintaining the dogs in good spirits.
Calling vets in NZ…
We are now inviting more dogs in New Zealand with treatment naïve lymphoma to help complete the final optimisation of the Phase 2 trial in a bridging program before moving on to a registration trial.
A veterinary trial centre has been set up in Veterinary Specialists Aotearoa clinic in Sylvia Park, Auckland.
To date, one enrolment has successfully completed a standard 28-day therapy program with Monepantel. The owners were very happy with the quick reduction in the size of the nodes and the improvement in the energy levels of their pet after treatment started. The lymphoma was stabilised by Monepantel after 28 days of treatment.
Which dogs with lymphoma are eligible?
To participate in the Phase 2b trial, 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 11kg.
Owners will have to transport their dogs to their respective centres and pay the cost of the initial consultation for diagnosis. Once the pet is diagnosed with lymphoma, PharmAust will cover all clinical trial costs, including travel expenses to and from the trial centre as well as post-trial maintenance treatment if both pet owners and vets consider this might be beneficial.
The MPL tablets will be administered at home and owners will be asked to keep a simple logbook during the trial period.
Pet owners interested in enrolling their dog in the MPL trial need to contact their veterinarian for a referral to the VSA clinic.
Veterinarians in NZ – for questions about patient referrals or the NZ study site, please email Dr Tommy Fluen or Dr Mike Coleman at medicine@vsnz.co.nz
For questions on the study program, please contact Richard Mollard, Chief Scientific Officer, PharmAust Ltd on rmollard@pharmaust.com or Kim Agnew, Study Principal Investigator, KAP Consulting Pty Ltd on kim@kapconsulting.com.au
Testimonials for dogs already treated on the trial can be found here.
