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PharmAust Ltd

Pharmaust Logo 002

PharmAust Ltd

Contact:
Dr Roger Aston, Executive Chairman

Telephone:
(08) 9202 6814

Email:
rogeraston@pharmaust.com

Website:
https://pharmaust.com/

Address:
1 Kyle Way, Suite 116, Claremont 6010 WA, Australia

PAA’s lead drug candidate is monepantel (MPL), a novel, potent and safe inhibitor of the mTOR pathway – a pathway having key influences in cancer growth.

MPL has been evaluated in Phase 1 clinical trials in humans and Phase 1 & 2 clinical trials in dogs. MPL treatment was well-tolerated in humans, demonstrating preliminary evidence of anticancer activity.

MPL treatment was tolerated in dogs and demonstrated objective anticancer activity and objective clinical benefit in dogs. Details of the trial and trial centres can be found on the company website at: https://www.pharmaust.com/petdogtrial/

Phase 2 to 3 Bridging Trial Currently Recruiting

The MPL trial is ongoing and currently transitioning from Phase 2 to Phase 3. Finalisation of dosing optimisation is underway, and investigating MPL in combination either with prednisolone or CHOP-based protocols  is also possible at selected centres[1].

The trial involves treatment at home with a consultation at the dog’s nearest trial centre, listed below. Basic Inclusion and Exclusion criteria are also listed. Trial centre veterinarians will provide greater detail about enrolment and the nature of the trial.

Phase 3 Trials Starting Soon

The Phase 3 trial is targeting an approximate March 2022 start date and will formally test the combinations for registered use as approved therapeutics.

[1] L- asparaginase, vincristine, cyclophosphamide, prednisolone, and doxorubicin

More about Monepantel (MPL)

MPL is already approved for veterinary use for a different indication and species. MPL is a very safe drug with very minimal side effects. PharmAust is aiming to repurpose MPL as an approved, effective and alternative cancer treatment.

Currently, the best indicated treatment option for B cell lymphoma is chemotherapy, which comes with several limitations and adverse events, and unfortunately, relapse can occur within six to 12 months.

Veterinary Trial Centres

The following veterinary trial centres have been set up to evaluate MPL in dogs that have been newly diagnosed with treatment naïve (not undergone any treatment) B cell lymphoma:

"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 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. In the second trial, we have better defined an optimal dose and three of four dogs at this optimal dose have enjoyed a good extension and high quality of life after the trial in monepantel combination with prednisolone over 18 weeks, with two ongoing. This is more than twice as long as expected from prednisolone alone”

No safety issues, improved taste

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

“This tablet completely resolved the taste problem and allowed us to significantly increase the dose being given in a second Phase IIa trial,” said Dr Mollard. 

Which dogs with lymphoma are eligible?

To participate in these trials, 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 (analysis of whether the cancer is a B cell or T cell type) is covered as part of the initial 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.

Discover more by visiting the PharmAust Australia website www.pharmaust.com

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