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PharmAust is calling for pet dogs with B cell lymphoma for the next clinical phase of promising anti-cancer trial running in Australia, New Zealand and now the USA
Biotech company PharmAust is continuing recruitment of pet dogs in Australia and New Zealand with untreated B cell lymphoma to finalise the evaluation of a promising, newly formulated anti-cancer drug.
Lymphoma is a common and aggressive cancer diagnosed in dogs. Symptoms can include swellings (enlarged lymph nodes), lethargy, weight loss and loss of appetite.
“There is no cure for B cell lymphoma at the moment. Usually, only 50% of dogs with B cell lymphoma will survive without treatment for around 30 days and the other half will mostly have severe progressive disease*,” said Dr Roger Aston, Executive Chairman of PharmAust.
“Currently, the best-indicated treatment option for canine lymphoma is chemotherapy, which comes with its own set of limitations and adverse events, and unfortunately, relapse can occur within six to 12 months of treatment.”
Furthermore, the most common side effects of a dog being treated with chemotherapy include gastrointestinal effects (vomiting, diarrhea or loss of appetite) and decreases in blood cell counts.
Veterinary trial centres in Australia, NZ & the USA evaluating the use of Monepantel in dogs
Veterinary trial centres have been set up in Australia, New Zealand and the United States to evaluate the anti-cancer drug Monepantel in dogs that have been newly diagnosed with B-cell lymphoma and have not started any other treatment. The drug is already approved for veterinary use for a different indication and species. PharmAust is aiming to repurpose MPL as a safe and effective cancer treatment.
Following early Phase 2 success in Australia and to prepare for a trial to formally register MPL in pet dogs, PharmAust is now also conducting this clinical trial in New Zealand and expects the first enrolment in the United States trial site in August.
“During Phase 2a and Phase 2b trials, Monepantel demonstrated effective anti-cancer activity and minimal side effects, which supports continued development into Phase 3 registration trials,” said Dr Kim Agnew, Principal Investigator of the trial.
“The commercial target is to develop and partner a product that supersedes the use of prednisolone alone, providing a canine lymphoma treatment option that can be administered daily by the owner and allowing the dog to maintain an excellent quality of life during treatment. Survival expectations are anticipated to align to a range of single active chemotherapy programs in dogs.”
Dogs in MPL treatment had a high quality of life
Post-trial, some veterinarians and the respective pet owners have elected to continue the MPL treatment and, sometimes, in combination with prednisolone, said Dr Agnew.
“The combination with prednisolone, which has provided average extension of survival to these pet dogs of 16-24 weeks, more than double the life expectancy than standard of care (palliative steroid therapy) that typically provides for 6–8-week survival in association with a range of adverse events,” he said. “Pet dogs treated during and after the trial at this optimum level experienced a high quality of life and minimum adverse events were reported.”
Twenty-seven pet dogs have now been treated using MPL monotherapy. With continued positive outcomes, PharmAust is preparing for a successful Phase 2 completion and the commencement of a subsequent registration trial.
Of the 16 pet dogs with optimum blood levels, 13 have achieved stable target lesions. This includes one dog with a partial response (60% regression). Nine of the 16 dogs with optimum blood levels have achieved stable disease by RECIST (Response Evaluation Criteria in Solid Tumours). Side effects were minimal or not detected.
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)
Dogs of any sex and at least one year of age
Immunophenotype can be pending but must be submitted, and needs to be B-cell to confirm enrolment
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 five sites in Australia, one site in New Zealand and one site in the United States:
Animal Referral Hospital in Homebush, Sydney NSW
Western Australian Veterinary Emergency and Specialty (WAVES) in Success, Perth WA
Perth Veterinary Specialists, Osborne Park, Perth WA
Animal Referral Hospital in Sinnamon Park, Brisbane QLD
Veterinary Specialist Services in Jindalee, Brisbane QLD
Heart of Texas Veterinary Specialty Centre, Texas USA
Owners will have to transport their dogs to their respective centre 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. Testimonials for dogs already treated on the trial can be found here
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 Principal Investigator, Dr Kim Agnew at kim@kapconsulting.com.au
For questions about the MPL trial program, please contact Dr Roger Aston, Executive Chairman, PharmAust Ltd atrogeraston@pharmaust.com
Dr Roger Aston currently serves as Executive Chairman of PharmAust. Dr Aston brings more than 20 years experience in the pharmaceutical and healthcare industries in senior roles in the UK, Asia Pacific and Australia. He has had extensive experience on boards and as Chief Executive Officer of many private and publicly listed biotechnology companies. During his career, he has been closely involved in start-up companies and major pharmaceutical companies. Aspects of his experience include FDA and EU product registration, clinical trials, global licensing agreements, fundraising through private placements, and a network of contacts within the pharmaceutical, banking and stock broking sectors. Dr Aston holds a B.Sc. (Hons) and Ph.D. degrees from the University of Manchester from 1975 to 1981.
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