PharmAust Limited

PharmAust (ASX:PAA) has reported that its monepantel tablets remain within specifications for human clinical trials, after being independently tested in storage for 12 months.

Monepantel is an inhibitor of the mTOR pathway - a pathway having key influences  in cancer growth and neurodegenerative diseases.

PharmAust says the development allows it to move toward Phase 2 human trials and look for potential commercial partners.

It also says with the completion of this 12-month Good Manufacturing Practice Stability Study, the company is now owed a $118,926.80 milestone grant payment from FightMND.

PharmAust (ASX:PAA) is conducting a Phase 2 trial for canines with B-cell lymphoma in Australia, New Zealand, and the USA.

So far, two dogs have had a partial response with a decrease in cancer tumour size, and another eight have had stable disease response.

One patient has surpassed 280 days with stable disease and a maintained quality of life.

The study aims to bridge the options of standard-of-care with chemotherapy and is expected to be completed by mid-2023.

PharmAust (ASX:PAA) has announced its lead drug candidate monepantel (MPL) has shown minimal side effects and an increase in survival time, in Phase 1 clinical trials in humans and Phase 2 clinical trials in dogs.

The clinical-stage biotechnology company developing therapeutics for both humans and animals says one dog surpassed 240 days with stable disease and continued excellent Quality of Life (QoL).

It says the drug is a novel, potent, and safe inhibitor of the mTOR pathway—a pathway having key influences in cancer growth and neurodegenerative diseases.

PharmAust is also recruiting pet dogs with B-cell lymphoma to complete the Phase 2 evaluation and require 8 of a further 20 dogs to meet Bayesian outcomes for a successful Phase 2 trial.