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Cytopia Commences Phase II Cancer Drug Study
Date:12/17/2007

$3 billion by 2013.

Cytopia is also currently conducting a Phase I study investigating the safety and tolerability of CYT997 following oral administration. The company also intends to file regulatory applications in support of other Phase II studies over the coming months.

The following table provides a summary of the key aspects of the Phase II multiple myeloma trial.

Name of trial A prospective, single-arm, two-stage, open-label

Phase II trial of CYT997 in relapsed and

refractory multiple myeloma (CCL07001)

Primary endpoints Determination of the overall response rate to CYT997

Secondary endpoints Time to progression; number of cycles of CYT997 to

achieve maximum response; overall survival and

safety and tolerability

Blinding status Not blinded

Product development Drug substance and drug product are manufactured to

status GMP standards

Treatment method

Route 24 hour intravenous infusion dose

Frequency Days 1 and 8 of a 21 day cycle

Dose-levels 202 mg/m2 CYT997 dihydrochloride

Number of trial 24 patients maximum

subjects

Subject selection Eligible patients must have a diagnosis of

criteria multiple myeloma (per World Health Organisation

criteria) and have received at least one but no

more than three previous lines of therapy

Trial location Melbourne, Australia

Expected completion Interim analysis (14 patients) Q3, 2008

Trial standard ICH-GCP

About Cytopia

Cytopia Ltd is an Australian biotechnology company focused on the discovery and development of new drugs to treat cancer. Cytopia conducts its research and development via subsidiaries based in
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SOURCE Cytopia Limited
Copyright©2007 PR Newswire.
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