Biotech company PharmAust (ASX: PAA) has officially begun recruitment for the phase IIb trial of its lead anti-cancer drug monepantel (MPL) on canine lymphoma and has put a call out for more dogs to participate.
The trial will test the effects of MPL upon pet owners’ dogs with treatment-naïve B cell lymphoma – that is, dogs that have not undergone any treatment for this cancer.
PharmAust today confirmed “several” dogs have been successfully recruited and have started treatment with MPL tablets.
Meanwhile, six other dogs that were not eligible for the trial have commenced treatment with the tablets on a compassionate basis.
“PharmAust will be pleased to update the market when a sufficient number of dogs with meaningful trial endpoints have completed their treatment regimen,” the company stated.
PharmAust announced the start of the phase IIb trial last month, following a successful phase IIa trial in which tumour regression and stable disease resulted. It also comes after the completion of a phase I trial in humans.
PharmAust chief scientific officer Dr Richard Mollard said the initial trials in pet dogs with cancer had proven successful so far.
“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,” he said.
According to Dr Mollard, there is currently no cure for B cell lymphoma.
“Usually, only 50% of dogs with B cell lymphoma will survive without treatment for around 30 days and the other half will have progressive disease,” he said.
Currently, the best indicated treatment option for canine lymphoma is chemotherapy, which has limitations and adverse events, and unfortunately, relapse can occur within six to 12 months.
MPL has been described by Dr Mollard as “comparatively gentle”.
“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,” Dr Mollard said.
Eligibility for the phase IIb trial
PharmAust said dogs eligible to participate in the phase IIb trial can have any stage of lymphoma but must be feeling generally well.
Immunophenotyping is covered as part of the screening process to analyse whether a canine patient’s cancer is a B cell or T cell type, with dogs only given the treatment if it is B cell based.
To be eligible for the new clinical trial program, dogs must also: have had no previous treatment in the last eight weeks, including corticosteroids; have no other significant concurrent medical problems; have good quality of life; and should weigh more than 11kg.
The MPL program will run in New South Wales, Queensland and Western Australia with consultations and treatments occurring at five sites.
These trial centres are: Animal Referral Hospital in Homebush (Sydney), Western Australian Veterinary Emergency and Speciality in Success (Perth), Perth Veterinary Specialists in Osborne Park (Perth), Animal Referral Hospital in Sinnamon Park (Brisbane) and Veterinary Specialist Services in Underwood (Brisbane).
PharmAust said two other sites in Melbourne and Sydney are anticipated to re-join in February/March.
The MPL tablets will be administered at home and owners will be asked to keep a simple logbook during the trial period.