PharmAust Limited (ASX: PAA) today announced the completion of anticancer clinical trials of various monepantel (MPL) tablet prototypes. These test which were conducted on healthy Beagle dogs in collaboration with research company BRI Biopharmaceutical has provided a strong basis for the company to form its therapeutic MPL platform.
Levels of monepantel (MPL) in the blood just by the intake of one tablet exceeded the levels anticipated to achieve anticancer activity. These MPL activity levels of anticancer have been evaluated through vitro test on human cancer cell lines, vivo test in mouse model for human cancer cell engrafted in it, and previously conducted clinical trials in human patients with cancer.
In the previously reported clinical study in dogs with B-cell lymphoma did not perform blood analysis due to ethical consideration. But with the extrapolation of monepantel (MPL) tablet data, it has been suggested that that the monepantel levels in the blood of the healthy Beagle dogs just from a single tablet has exceeded the dose for anticancer activity required in the previous clinical pilot Phase II study.
Clinical-stage oncology company PharmAust Limited now possess the sufficient data to take the relatively cheap tablet to GMP manufacture through an advancement process with cGMP grade MPL.
The report read that during the next stage, monepantel (MPL) tablets will be used in formal dose escalation program in healthy Beagle dogs to assess the highest dose that can be given and with what safety margin. It forms the most essential part of the drug development process. The company said that though previous studies in dogs and sheep have suggested that blood levels for anticancer activity declines within an acceptable margin of safety, it is vital to get it formally proved for the concerned authorities before commercializing the product out in the market.
With the formulation of new monepantel (MPL) tablet, the company has achieved good absorption which is essential for the next stages as it is going to be the product with which the company will conduct its efficacy study for Phase II, expected to begin in Q1 2019.
PharmAust’s Chief Scientific Officer Dr. Richard Mollard stated that the new tablet data has been encouraging for the company as it can now move ahead with the next step of formally proving the anticancer activity in target species in clinical trials.
Despite announcing significant progress in monepantel (MPL) tablet program, the share price of PAA has plunged by 7.843% to close at $0.047 on 19 October 2018. The stock has seen a performance change of -1.92% over the past one year.
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