PharmAust has confirmed that its flagship anti-cancer drug, “Monepantel”, produced using the recently determined good manufacturing practice, or “GMP” process, has performed well in the lab.
This follows testing of Monepantel manufactured using this method on human cancer and non-cancer cell lines by researchers at the Olivia Newton-John Cancer Research Institute, or “ONJCRI”, in Melbourne.
Notably, the tests found that the newly manufactured Monepantel continued to kill cancer cells without affecting non-cancerous cells, a major leap forward in an industry where many cancer fighting methods tend to kill the good cells with the bad – hence the loss of hair and other sides effects in many more traditional cancer fighting methods.
The result is in line with previous independent testing by the ONJCRI in September, which confirmed that human brain, breast, ovarian and prostate cancer cell lines were all affected by the drug.
PharmAust said the cancer cell lines tested included models of cancers that it is planning to target in Phase II clinical trials in humans.
Management plans to use this Monepantel in further preclinical molecular pathway targeting studies now to improve its understanding of how the drug kills cancer cells.
GMP is a globally recognised standard that requires rigorous, controlled and continually documented processes to produce drugs with very high levels of purity for safe and effective use when administered to patients.
PharmAust Chief Scientific Officer Dr Richard Mollard said: “Recapitulating the anti-cancer effect of Monepantel manufactured according to the PharmAust method in vitro is an important outcome.”
“The PharmAust method does not appear to change the properties of monepantel and therefore is not predicted to change the anticancer properties of PharmAust’s monepantel analogues too. Future work will formally test this assertion and PharmAust is now in a strong position to advance its preclinical and drug development pipeline as needed.”
The PharmAust GMP method of producing Monepantel and its analogues was validated by research and manufacturing organization, Syngene, in October.
This effectively secured its ability to manufacture its aminoacetonitrile drug development pipeline.
Last month, the company signed an agreement with US company Catalent Pharma Solutions for the GMP-grade manufacture of Monepantel for its upcoming clinical trials on dogs.
Manufacturing the tablets to GMP standards appears to be the key to undertaking good clinical practice trials and will enable the data from the trials to be admissible to the US Food and Drug Administration to support new drug registration programs.
The coming year will be a watershed for PharmAust with the company set to carry out Phase II clinical tests for Monepantel in dogs and returning to human trials.
