Call for dogs to help continued evaluation of exciting new anti-cancer drug

The ongoing Phase 2 trial for the drug monepantel (MPL) is finalising dose optimisation and is a prelude to a multi-institutional canine cancer Phase 3 trial to start early next year.

The trial’s principal investigator Dr Kim Agnew is leading a team of highly qualified veterinary oncologists in New South Wales, Queensland and Western Australia who are evaluating MPL in dogs that have been newly diagnosed with B-cell lymphoma and have not started any treatment.

PharmAust is currently setting up Agreements for additional trial centres in New Zealand and the United States in preparation for the broadened reach required for the Phase 3 trial.

Cancer is the number one cause of death in dogs over the age of 2*. Lymphoma is one of the more common cancers in dogs and occurs in the white blood cells of the immune system. Symptoms can include tumours, lethargy, weight loss and loss of appetite.

National Canine Lymphoma Awareness Month is a reminder to pet owners to regularly inspect your pet for any lumps or bumps and pay attention to sudden changes in appearance and behaviour.

“The key to a good prognosis with canine lymphoma is early diagnosis and this particular form of cancer is very rapidly progressive, so it’s important to act quickly,” said Dr Agnew.

MPL shown to be a safe and effective cancer treatment

MPL 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.

“During the trials to date, over 25 pet dogs have been treated with MPL for lymphoma and the results are very promising,” said Dr Agnew.

“So far, we have shown that the new MPL tablet is very palatable and easy for pet owners to administer at home. Furthermore, at the recently identified optimal drug blood levels, side effects seem to be very minimal and all pet dogs that have maintained these levels over the course of treatment, have been assessed as at least stable disease by the administering veterinarians.

“Some pet dogs have continued after the trial on a combination of this optimum level of MPL and prednisolone, and all have exceeded the life expectancy of dogs that might be administered only prednisolone at diagnosis.”

Veterinary trial testimonies can be found here.

PharmAust inviting more dogs to help complete trial

PharmAust was pleased to successfully meet its predetermined interim goals demonstrating both significant objective clinical benefit and significant overall response rate. It is now inviting more dogs with treatment naïve lymphoma to help complete the final optimisation of the Phase 2 trial in a bridging program before moving into the Phase 3 trial.

“PharmAust’s long term strategy is to develop MPL to treat cancer in both dogs and humans,” said Dr Richard Mollard, CSO of PharmAust and CEO of PharmAust’s wholly owned subsidiary Pitney Pharmaceuticals Pty Ltd.

“In pet dogs with treatment naïve B-cell lymphoma and in humans with treatment refractory cancer, Monepantel displays strong evidence of anti-cancer activity.  However – and perhaps more interestingly following our retrospective analysis of trial data in combination with prednisolone – Monepantel could be capable of doubling the life expectancy of pet dogs with B-cell lymphoma compared to if treated with just prednisolone alone. We now plan to do some more analysis and formally test this hypothesis in the Phase 3 clinical trial.

“Most importantly, all dogs also appear to enjoy a high quality of life while taking Monepantel, with reports of trial participants enjoying camping and playing at the park and at the beach with their owners.”

Program entry criteria

The canine entry criteria for MPL Clinical Trials can be found here and include:

• Any stage lymphoma (based upon physical exam, abdominal ultrasound and thoracic Xray)
• Substage a (feeling well)
• Immunophenotype can be pending, but needs to be B-cell based on clinical characteristics
• No previous treatment, including corticosteroids (prednisolone)
• No other significant concurrent medical problems
• Good quality of life.

The MPL program currently involves three consultations at the clinical trial sites (admission, at two weeks and at four weeks). These clinical trial sites are also listed here.

Owners need to transport their dogs to and from the trial sites for these three consultations.  PharmAust will cover all trial costs, including for pet owners located at some distance to the trial sites, travel expenses as well as overnight hotel stay if needed.

For more information or to enrol, please contact Dr Richard Mollard on rmollard@pharmaust.com

Source: Press Release

Photo: Freepik