Calling for dogs for anti-cancer drug trials…
PharmAust anti-cancer drug trials meeting targets, calling more dogs!
Biotech company PharmAust is calling for more dogs with B cell lymphoma in a Phase IIb trial to help evaluate its newly formulated anti-cancer drug Monapantel (MPL), shown to be safe and effective for dogs that have not undergone any treatment for this cancer.
This trial comes following the completion of a Phase I trial in humans and Phase II and IIa trials in pet dogs of the same drug. Lymphoma is a common cancer diagnosed in dogs. Symptoms can include swellings (enlarged lymph nodes), lethargy, weight loss and loss of appetite.
“Currently, there is no cure for B cell lymphoma,” said Dr Richard Mollard, Chief Scientific Officer of PharmAust. “Usually, only 50% of dogs with B cell lymphoma will survive without treatment for around 30 days and the other half will have progressive disease¹.”
Veterinary trial centres are set up in New South Wales, Queensland and Western Australia to evaluate MPL in dogs that have been newly diagnosed with treatment naïve (not undergone any treatment) B cell lymphoma. Two other trial sites in Melbourne and Sydney are expected to start up in February/March.
MPL is already approved for veterinary use for a different indication and species. PharmAust is aiming to repurpose MPL as a safe and effective approved cancer treatment.
“So far, the initial trials in pet dogs with cancer have proven successful,” said Dr Mollard. “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.”
No safety issues, improved taste
No safety issues were encountered in this 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 resolved the taste problem and allowed us to significantly increase the dose being given in a second Phase IIa trial,” said Dr Mollard. “From this trial, using this tablet we were able to identify an optimal dose where anti-cancer activity was maximised. At this dose, one dog’s total tumour burden reduced by over 60 percent and some of the individual tumours disappeared, all within 14 days. It is this dose that we are now taking into the new Phase IIb trial.”
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.
“Monepantel is comparatively very gentle and we would like to see dogs doing well over the first 28-day period, then three and six months, and longer,” said Dr Mollard. “If this trial determining the optimal prescribed dose is a success, PharmAust will embark on a larger Phase III trial. Going forward, owners of pet dogs with B cell lymphoma will then be given a greater choice of treatment options for their dogs. PharmAust would like to see dogs feeling considerably better, with tumours either disappearing or stabilised.”
Which dogs with lymphoma are eligible?
To participate in the Phase IIb 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.
Participating vet clinics
The MPL program now commencing involves consultations/treatments at the dog’s nearest trial centre, which currently includes the following five sites:
Animal Referral Hospital in Homebush, Sydney NSW. Dr Sonya Yu (02) 9758 8666
Western Australian Veterinary Emergency and Specialty (WAVES) in Success, Perth WA. Dr Sue Bennett (08) 9412 5700
Perth Veterinary Specialists, Osborne Park, Perth WA. Dr Jessica Finlay (08) 9204 0400
Animal Referral Hospital in Sinnamon Park, Brisbane QLD. Dr Kathleen O’Connell (07) 3172 0593
Veterinary Specialist Services in Underwood, Brisbane QLD. Dr Catherine Chan (07) 3841 7011
Two other sites in Melbourne and Sydney are anticipated to re-join the trial in the near future.
Owners will have to transport their dogs to their respective centre and pay the cost for 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 their nearest trial centre.
Veterinarians – for questions about patient referrals or trial sites, please contact Dr Richard Mollard at rmollard@pharmaust.com
DOG CANCER FACTS
Close to 50% of dogs over the age of 10 will develop cancer and approximately 1 in 4 dogs will at some stage in their life develop cancer, according to the Vet Cancer Society².
PharmAust offers a reminder to regularly inspect your pet for any lumps or bumps and pay attention to sudden changes in appearance and behaviour, which can help with early detection.