Cytopia concludes dose-escalation in Phase I cancer trial

The primary objectives of this safety and tolerability study have been achieved. These were to determine the maximum tolerated dose and the dose-limiting toxicities for the agent when administered orally in capsule form every two weeks to patients with a diverse range of solid tumors, the company said. Safety and tolerability data from this study augments data obtained in the company’s first Phase I study where CYT997 was administered intravenously.

Together, these studies suggest that the CYT997 is a potent and selective vascular-disrupting agent (VDA) which is well tolerated at biologically efficacious doses and is worthy of further investigation as a novel anticancer agent, the company added.

The company has already commenced Phase II studies for the intravenous form of CYT997 and intends to undertake similar efficacy studies for the oral presentation. Investigating the safety and efficacy of metronomic dosing, frequent oral administration at a comparatively low, but biologically effective dose, is of particular interest, said Cytopia. This oral trial was partly funded under the company’s A$3 million commercial ready grant.

Analysis of biological and clinical data from the study is currently ongoing and the company expects to present a finalized trial report, including a complete list of adverse events and the recommended dose for Phase II studies, shortly.

Andrew Macdonald, CEO of Cytopia, said: Cytopia has now demonstrated the broad clinical potential of CYT997 in both intravenous and oral forms. The oral activity of CYT997 is a key advantage over most other VDAs which are administered intravenously. The oral activity of the agent should markedly improve its clinical and commercial value.