Biotech company PharmAust is calling for more dogs with B cell lymphoma in aPhase IIb trial to help evaluate its newly formulated anti-cancer drugMonapantel (MPL), shown to be safe and effective for dogs that have notundergone any treatment for this cancer.

This trial comes following the completion of a Phase I trial in humans andPhase II and IIa trials in pet dogs of the same drug. Lymphoma is a commoncancer diagnosed in dogs. Symptoms can include swellings (enlarged lymphnodes), 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 celllymphoma will survive without treatment for around 30 days and the other halfwill have progressive disease¹.”

Veterinary trial centres are set up in New South Wales, Queensland and WesternAustralia to evaluate MPL in dogs that have been newly diagnosed withtreatment naïve (not undergone any treatment) B cell lymphoma. Two other trialsites in Melbourne and Sydney are expected to start up in February/March.

MPL is already approved for veterinary use for a different indication andspecies. PharmAust is aiming to repurpose MPL as a safe and effective approvedcancer 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 theoriginal liquid formula, six of seven dogs achieved stable disease over aprescribed 14-day trial period, with six of seven dogs also showing reductionsin their tumour sizes.”

No safety issues, improved taste

No safety issues were encountered in this first trial; however, the drugformula had a particularly unpleasant taste. So, the drug was reformulatedfrom liquid to a more convenient and very easy-to-swallow tablet.

“This tablet resolved the taste problem and allowed us to significantlyincrease 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 dosewhere anti-cancer activity was maximised. At this dose, one dog’s total tumourburden reduced by over 60 percent and some of the individual tumoursdisappeared, all within 14 days. It is this dose that we are now taking intothe new Phase IIb trial.”

Currently, the best indicated treatment option is chemotherapy, which comeswith its own set of limitations and adverse events, and unfortunately, relapsecan occur within six to 12 months.

“Monepantel is comparatively very gentle and we would like to see dogs doingwell 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 asuccess, 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 oftreatment options for their dogs. PharmAust would like to see dogs feelingconsiderably 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 butmust be feeling generally well. Ultimately, the patient will only be given thetreatment if they have B cell lymphoma but immunophenotyping (analysis ofwhether the cancer is a B cell or T cell type) is covered as part of theinitial 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’snearest 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 trialin the near future.

Owners will have to transport their dogs to their respective centre and paythe cost for initial consultation for diagnosis. Once the pet is diagnosedwith lymphoma, PharmAust will cover all clinical trial costs, including travelexpenses to and from the trial centre as well as post trial maintenancetreatment 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 keepa simple logbook during the trial period.

**Pet owners interested in enrolling their dog in the MPL trial need tocontact 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 [email protected]

DOG CANCER FACTS

**** Close to 50% of dogs over the age of 10 will develop cancer andapproximately 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 orbumps and pay attention to sudden changes in appearance and behaviour, whichcan help with early detection.

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