PharmAust Ltd (ASX:PAA), a clinical-stage oncology company, says it has executed an agreement with a major US Contract Research Organisation to commence Phase 1 clinical trials with the newly formulated monepantel tablet.
The company said the trial design has four stages covering optimal dietary conditions for administration, safety, and dosing frequency. The final stage will look establis28-day day repeat-dose drug level study to determine optimal tablet administration frequency as a prelude to the commencement of a Phase 2 anticancer study in pet owners’ dogs with cancer.
According to PharmAust chief scientific officer Dr Richard Mollard, “PharmAust is very pleased to enter into this agreement. The trial design should provide the required information to enable the best possible treatment for pet owners’ dogs with cancer in the upcoming Phase II trials.
"Further, because monepantel is now in a tablet instead of a liquid, the safety component of this trial design would potentially form part of the bridging component required for regulatory authorities such as the FDA for establishing an Investigative New Drug Application for clinical trials in humans.”