ASX listed Pharmaust is starting to look really interesting following the completion a “first in human trial” of its PPL-1 ant-cancer drug sometimes known as Monepantel.
The company recently received the results of a phase 1 human trial at the Royal Adelaide Hospital on patients with solid cancerous tumours that had previously failed to respond to traditional chemotherapy.
Pharmaust labelled the results “highly significant” after the study concluded that two patients with elevated levels of a chemical usually associated with cancer known as p70s6k, actually saw a suppression of those levels after taking PPL-1 orally for about a week.
Furthermore the study determined that the PPl-1 drug was active in supressing levels of p70s6k in peripheral immune cells giving the company confidence that it is active against markers that have been correlated with aggressive features of cancer such as growth, invasion, and the spreading of cancer to other cells.
An evaluation of white blood cells of patients who took PPL-1 for either three or seven consecutive days also showed a reduction of a second chemical that is also associated with cancer known as p-4E-BP1.
The company says that the drug also demonstrated a very good safety profile when compared to many other established anti-cancer drugs however a need to make the drug more palatable was identified during the trial.
Pharmaust will now move to undertake a phase 2 trial by introducing PPL-1 to people at the same time that they undertake chemotherapy to determine what effect the combination of both PPL-1 and chemotherapy will have.
Previous trials in animals have already shown that PPL-1 can significantly enhance chemotherapy without the associated enhancement of toxicity.
Pharmaust Executive Chairman Dr Roger Aston said Dr Aston said “This is a very strong result for our Phase I trial which will now allow us to proceed as soon as possible to a Phase II evaluation of PPL-1. Preliminary discussions with physicians at both the Royal Adelaide Hospital and at Clinical Research Centres in the UK signal strong interest to evaluate PPL-1 where first line therapy has failed.
Following some additional contractual studies, which we will report upon, we expect to be able to select what chemotherapy is preferred to be used in conjunction with PPL-1 in the next trial.” Said Dr Aston
Monepantel, which is the technical name for PPL-1 was first developed as a sheep dip de-wormer which provides some indication that it may be safe for humans as it is swallowed by sheep that are subsequently consumed by human beings.