Ann: FDA Guidance on NUZ-001 IND Application, page-6

Just hoping the additional animal data is from the Beagle Study that PAA/NUZ undertook.. as that is all PAA/NUZ owned and would be a simple fix ,,NZT

	Phase I Monepantel Tablets Demonstrate High Safety

Phase I Monepantel Tablets Demonstrate High Safety
• Groups of healthy beagle dogs successfully administered either 2, 4, 7 or 10 tablets in
Phase I single dose escalation study.
• No adverse clinical signs observed following administration at any dose.
• No apparent taste issues for dogs even after taking 10 tablets.
• Successful administration of 10 tablets provides an excellent safety margin.
• Guiding dosing strategy for upcoming anti-cancer Phase II trial
28 March 2019 – Perth, Australia: PharmAust Ltd (ASXAA), a clinical-stage oncology
company, is pleased to announce that it has received further positive results from its ongoing
Phase I trial programme in healthy beagle dogs.
This latest trial tested the safety of monepantel tablets in an escalating single dose study. The
beagles were sequentially treated with either 2, 4, 7 or 10 tablets and then monitored over
three days for the appearance of any adverse clinical signs. Monepantel tablets were very well
tolerated at all levels. No adverse effects, toxicity or safety related observations were reported
by the US-based independent research organisation conducting the study.
This also follow’s PharmAust’s 14 March announcement that reported that one tablet was
sufficient to provide blood levels that associate with anti-cancer activity. The lack of adverse
effects following administration of 10 tablets attests to an excellent safety margin for anticancer treatment.
Importantly, for the Phase II study due to begin on completion of the imminent 28-day
pharmacokinetic (PK) programme, no apparent taste issues were noted for dogs that were
administered 10 tablets in one dose. This observation attests to the high palatability and
tolerance of the new tablet formulation when compared to the previously used liquid
formulation. PharmAust has now administered 61 tablets on 29 occasions to over 20 individual
healthy beagle dogs and no adverse effects have been recorded.
With this very high safety margin PharmAust will now commence daily repeat dosing tests to
determine how best to maintain long term monepantel blood levels that correlate with enduring
anti-cancer activity.

anti-cancer activity of monepantel in the upcoming Phase II trial. In the future it is envisaged
that pet owners will be able to administer these tablets very simply to their dogs at home.

	20th	Phase I Dog Trial with New Monepantel Tablets Commences

	14th	MPL Tablets Demonstrate Positive Performance in Phase 1

Many may recall that was the first breakthrough of K9's taking the Tablets freely from Clinicians hands and from the ground.. wishing we had the Humanised Mouse data that the previous BOD touted would be undertaken during the covid run... NZT

Timeline to get back on tract may be disclosed this afternoon?