Ann: Phase I Dog Trial with New Monepantel Tablets Commences, page-12

PAA Trial
7th February 2019 – Perth, Australia: PharmAust Ltd (ASXAA),
a clinical-stage oncologycompany, has executed an agreement with a major US Contract Research Organisation, tocommence Phase I clinical trials with the newly formulated monepantel tablet.
The Phase I trial design has four stages:
(i) validating the optimal dietary conditions for monepantel administration – e.g. totake on a full or empty stomach,
(ii) confirming the safety of monepantel at single dose in a dose escalation study,
(iii) determining the frequency of dosing required (every second or third day, forexample) to achieve blood levels predicted to be compatible with anticanceractivity, and
(iv) based upon (i), (ii) and (iii), establish a 28 day repeat-dose drug level study todetermine optimal tablet administration frequency as a prelude to commence thePhase II anticancer studies in pet owners’ dogs with cancer.
PharmAust’s Chief Scientific Officer Dr Richard Mollard commented, “PharmAust is verypleased to enter into this agreement. The trial design should provide the required informationto enable the best possible treatment for pet owners’ dogs with cancer in the upcomingPhase II trials. Further, because monepantel is now in a tablet instead of a liquid, the safetycomponent of this trial design would potentially form part of the bridging component requiredfor regulatory authorities such as the FDA for establishing an Investigative New DrugApplication for clinical trials in humans”.