ASX-listed clinical-stage biotech group, PharmAust has put out a call to pet owners who have dogs with B-cell lymphoma to allow their pets to participate in a Phase IIb trial to help the company evaluate its newly formulated anti-cancer drug Monepantel or “MPL”.
Perth-based PharmAust says recent trials have demonstrated that MPL is a safe and effective treatment for dogs that have not undergone any treatment for this type of cancer. The planned Phase IIb trial follows the completion of a Phase I trial in humans and Phase II and IIa trials in pet dogs using the same anti-cancer drug.
Lymphoma is a common cancer diagnosed in dogs, with symptoms including swellings (enlarged lymph nodes), lethargy, weight loss and loss of appetite. According to the Vet Cancer Society , close to 50 per cent of dogs over 10 years old will develop cancer and approximately one in four dogs will at some stage in their life develop cancer.
PharmAust Chief Scientific Officer, Dr Richard Mollard said: “Currently, there is no cure for B-cell lymphoma. Usually, only 50 per cent of dogs with B-cell lymphoma will survive without treatment for around 30 days and the other half will have progressive disease.”
“So far, the initial trials in pet dogs with cancer have proven successful. 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.”
PharmAust explains there were no safety issues encountered in the earlier dog trials, however the drug formula had a particularly unpleasant taste. It reformulated MPL from liquid to a more convenient, easy-to-swallow and a lot tastier anti-cancer tablet for pooches.
Dr Mollard said: “This tablet resolved the taste problem and allowed us to significantly increase the dose being given in a second Phase IIa trial. 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 per cent 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 cancer 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. PharmAust points out MPL is comparatively very gentle.
MPL trial centres have been set up at five vet clinics in WA, NSW and Queensland to analyse the anti-cancer drug in dogs that have been newly diagnosed with B-cell lymphoma and have not undergone any treatment. Two further trial sites, in Melbourne and Sydney, are expected to be established next month or in March.
Dog owners will be required 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 says it will cover all the clinical trial costs, including travel expenses to and from the trial centre as well as post-trial maintenance treatment if pet owners and vets consider it to be beneficial.
The anti-cancer MPL tablets will be administered at home and dog owners will be asked to keep a logbook during the trial period.
Pet owners interested in enrolling their dog in the MPL trial need to contact their vet for a referral to their nearest trial centre, while vets who have questions about patient referrals or trial sites can contact Dr Mollard (at rmollard@pharmaust.com) for assistance.
Veterinary clinics participating in the MPL program now commencing are the Animal Referral Hospital in Homebush, Sydney, the Animal Referral Hospital in Brisbane, Veterinary Specialist Services in Brisbane, Western Australian Veterinary Emergency and Specialties in Success, Perth and Perth Veterinary Specialists in Osborne Park, Perth.
PharmAust says consultations and or treatments will be carried out at the dog’s nearest trial centre.
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By Matt Birney
