ASX-listed PharmAust plans to start a phase one clinical trial of its cancer fighting drug, Monepantel, next year to see if it can help patients suffering from Motor Neurone Disease. The clinical-stage oncology company was recently awarded a grant of $881,085 from FightMND that will be used to conduct the trials. Melbourne-based FightMND was co-founded by former AFL player and coach, Neale Daniher, and is the largest independent funder of Motor Neurone Disease research in Australia.
It has committed a further $10.68 million this year towards Motor Neurone Disease research projects that are looking to crack the code for effective treatments and or find a cure for the debilitating neurological disease.
Monepantel was originally formulated to treat parasites in animals before PharmAust repurposed it as a cancer fighting drug, taking advantage of its safe status as a drug that has already entered the food chain via in its prior incarnation as a sheep-dip.
Since then it has also demonstrated a high safety profile in anti-cancer clinical trials in humans.
The drug is a safe and potent inhibitor of the “mTOR” pathway, which serves as a central regulator of cell metabolism, growth, proliferation and survival and a key driver of cancer. Monepantel is now being repurposed as a potential therapeutic in the battle to combat Motor Neurone Disease.
PharmAust’s phase one trial is designed to test the safety and tolerability of its Monepantel tablets on eight Australian patients who have Motor Neurone Disease.
Dr Susan Mathers and Professor Dominic Rowe have been appointed as the principal investigators who will oversee the planned trials at Calvary Health Care Bethlehem in Melbourne and the Centre for Motor Neurone Disease Research Faculty of Medicine and Health Research at Macquarie University in Sydney, respectively.
PharmAust Chief Scientific Officer, Dr Richard Mollard said: “PharmAust is delighted to be a successful applicant for the FightMND research fund. PharmAust is looking forward to assisting Dr Mathers and Dr Rowe in this trial.”
The Perth-based company says that as an mTOR inhibitor, Monepantel induces “autophagy”, which is a mechanism that cleans out misprocessed and excessive intracellular protein in neural cells associated with the cause of Motor Neurone Disease. Its theory is that Monepantel will benefit the health of patients’ neural cells by regulating problems associated with these proteins, thereby reducing MND-associated symptoms.
According to FightMND, drugs that inhibit the mTOR cellular pathway can help clear away the proteins/molecules that clump together and accumulate within cells that can cause damage and eventually the death of these cells.
Pre-clinical studies have shown that Monepantel can slow disease progression in Motor Neurone Disease models by clearing harmful materials in motor neurons that stick together and make them unwell.
The PharmAust phase one trial, which is earmarked to be completed by the end of 2021, aims to come up with the most appropriate safe dose of Monepantel to administer to the patients suffering from Motor Neurone Disease.
If the study points to Monepantel being safe and the drug shows signs of efficacy, a larger, phase two clinical trial designed to look at the impact of the drug on disease progression will be considered.
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