Cytopia Limited (ASX: CYT) has commenced dosing patients in the first of a suite of Phase II clinical studies for its vascular disrupting agent (VDA), CYT997. These studies will investigate the activity of this anti-cancer compound in specific cancer types with high unmet medical need and poor prognoses.
VDAs are a new class of drugs to treat cancer and have potential for “blockbuster” sales in the treatment of vascularized tumors. CYT997 has a dual mechanism of action shutting down established blood vessels that supply the tumor with nutrients and oxygen and also direct cytotoxic properties. Capable of being delivered orally as well as intravenously, the compound was discovered by Cytopia scientists in 2003 and an Investigational New Drug application was accepted by the US Food and Drug Administration in 2005 to commence Phase I studies. During the 2008 financial year Cytopia has: — commenced dosing in its first Phase II study — finalized preparations for its second Phase II study — concluded its first Phase I safety and tolerability study with intravenous administration — continued dose-escalation in its Phase I capsule dosing study (oral administration)
Phase II clinical programs
Following favorable findings in mesothelioma patients in Cytopia’s Phase I trial, the company is undertaking feasibility analysis for a Phase II study in mesothelioma patients who have failed the currently approved drug, Alimta (pemetrexed). This single-arm study of 20-30 patients would potentially be conducted at multiple centers in Australia, the United States and Asia. Activity in second-line mesothelioma could lead to expedited drug approval and a fast-to-market strategy for the compound in this cancer indication. It is anticipated that appropriate regulatory submissions to support this study will be filed in the third quarter of 2008.
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