Call for cases – MPL clinical trial for dogs with B-cell lymphoma

Veterinary trial centres have been set up across Australia to evaluate the a novel anti-cancer drug, Monepantel (MPL). The drug is already approved for veterinary use for a different indication and species. Biotech company PharmAust is aiming to repurpose MPL as a safe and effective cancer treatment. 

Researchers are recruiting dogs newly diagnosed with B-cell lymphoma that have not started any other treatment.

Early Phase 2 MPL trials in Australia have shown promising results. “During Phase 2a and Phase 2b trials, Monepantel demonstrated effective anti-cancer activity and minimal side effects,” said Dr Kim Agnew, Principal Investigator of the trial. “The commercial target is to develop … a product that supersedes the use of prednisolone alone, providing a caninelymphoma 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.” 

27 pet dogs have now been treated using MPL monotherapy. 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. 

Post-trial, some veterinarians and the respective pet owners have elected to continue the MPL treatment, sometimes in combination with prednisolone, said Dr Agnew. “Pet dogs treated during and after the trial at this optimum level experienced a high quality of life and minimum adverse events were reported.” 

Which cases 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 is covered as part of the initial screening. 

The entry criteria for the new clinical trial program are:

• Dog diagnosed with 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 (needs to be B-cell to confirm enrolment)
• No previous treatment in the previous eight weeks, including corticosteroids (prednisolone)
• No other significant concurrent medical problems
• Good quality of life
• The dog should weigh more than 11kg

The MPL program now commencing involves consultations/treatments at the dog’s nearest trial centre, which currently includes five sites in Australia: 

• 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

Owners will need 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. Testimonials for dogs already treated on the trial can be found here.

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 on rogeraston@pharmaust.com