Thanks ID2T ,, gaining lightweight toxicity data from Mice is...

Thanks ID2T ,, gaining lightweight toxicity data from Mice is usually very swift that's why they utilise it as quick detection

Mouse toxicity data can be collected over varying timeframes depending on the type of study. Acute toxicity studies typically involve a single dose or multiple doses within 24 hours, with observations for up to 14 days. Subchronic studies, like the 90-day oral toxicity study in rodents, involve repeated dosing over a longer period, usually 90 days. Chronic toxicity studies, assessing long-term effects, can last for 12 months or more

I've heard the previous Beagle Data for K9 toxicity was not up to speed for the FDA. Annoying as the Beagles were not cheap


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.
PharmAust’s Chief Scientific Officer Dr Richard Mollard stated, “These results continue to
support the very high safety profile associated with monepantel. The results further provide the
Company and its clinical associates with insight on a dosing strategy that will optimise the
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.”

Plus of course we have changed up the formula

Has anyone heard how the Liquid formulation is progressing??