Cytopia trials given FDA OK

The US Food and Drug Administration has approved a clinical trial of Melbourne biopharma Cytopia's (ASX:CYT) promising dual-acting lead anti-cancer molecule CYT997.

Cytopia's pre-clinical trials have confirmed that the drug has two independent modes of action, that could see it become a potentially generic drug for treating all types of solid tumours.

It starves tumours of oxygen and nutrients by inhibiting the formation of new blood vessels, and also disrupts the polymerization of the contractile protein tubulin, which self-assembles to form the tubilin fibres that tow newly replicated chromosome pairs apart when cells divide.

Cytopia's application to the FDA's Centre for Drug Evaluation and Research for investigational new drug (IND) status for CYT997 has been approved, clearing the way for a clinical trial in the world's largest anti-cancer drug market later this year, according to the company's CSO, Dr Andrew Wilks.

The company has also sought approval for a clinical trial via the Australian Therapeutic Goods Administration's clinical trial notification pathway.

YT997 is already in phase 1 (safety and tolerability) trials in the UK, after being accepted earlier this year into the clinical trials program of Britain's largest cancer-drug testing agency, Cancer Research UK.

CYT997 is a synthetic molecule, a structural cousin of Cytopia's proprietary JAK kinase cell-cycle disruptors.

Wilks said that with two potential modes of action, the drug could be administered intravenously in a bolus dose to act upon the patient's vascular system, as an angiogenesis inhibitor, and orally, as a maintenance dose, as an agent to disrupt the replication of cancerous cells.

"We'll have to investigate all these possibilities, but all-round, it's a very exciting drug," Wilks said.

"By the end of the year, we should have some information about its tolerability and safety, and with luck, some indication of efficacy, then we can roll out the other clinical trials - one in the US, and the other in Australia, in which we can address issues like its oral availability.