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Cytopia Concludes Phase I Oral Trial for Vascular-Disrupting Agent, CYT997
Date:2/5/2009

MELBOURNE, Australia, Feb.5 /PRNewswire/ -- Cytopia Limited (ASX: CYT) has successfully concluded dose-escalation in its oral Phase I study for CYT997, the company's anticancer vascular-disrupting agent (VDA).

The primary objectives of this safety and tolerability study have been achieved. These were to determine the maximum tolerated dose (MTD) and the dose-limiting toxicities (DLTs) for the agent when administered orally in capsule form every two weeks to patients with a diverse range of solid tumors. 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 VDA which is well tolerated at biologically efficacious doses and is worthy of further investigation as a novel anticancer agent.

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

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.

This oral trial was partly funded under the company's $A3 million Commercial Ready grant.

Preliminary trial data

CYT997 was generally well tolerated in this study with a maximum tolerated dose in cancer patients of ca 165 mg/m2. This dose resulted in maximal plasma concentrations some twofold higher than those obse
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SOURCE Cytopia Limited
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