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

rved in the Phase I intravenous infusion study at a comparable dose, indicating favourable oral absorption.

Three dose-limiting toxicities were observed, namely two cases of significant drug-induced fatigue and one case of hypoxia. Importantly, no significant prolongation of the corrected QT interval (a measure of cardiac conduction) was observed.

Patients entering the trial had advanced cancer that had failed to respond to other therapies or for which no other therapy exists. Each was eligible to receive a maximum of six cycles of CYT997 therapy, subject to clinical status. One patient continued to receive the drug beyond their initial six cycles due to prolonged disease stabilisation. No patients currently remain on study.

Secondary objectives of this Phase I study included the determination of a recommended dose for Phase II studies and pharmacokinetic assessment and a preliminary investigation of the anti-tumor properties of CYT997. 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, within three months.



    The following table provides a summary of the key aspects of this trial.

    -------------------------------------------------------------------------
    Name of Trial                   An accelerated dose-escalation study of
                                    CYT997 given as an oral capsule every two
                                    weeks in patients with advanced solid
                                    tumors (CCL06001).
    -------------------------------------------------------------------------
    Primary Endpoints               Determination of the dose-limiting
                                    toxicities and maximum tolerated dose of
                                    CYT997 given as a
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SOURCE Cytopia Limited
Copyright©2009 PR Newswire.
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