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Oral Tablet AP23573 Clinical Trial – Objectives

Oral Tablet AP23573 Clinical Trial – Objectives. Primary Determine safety, tolerability and MTD of multiple dose schedules of oral AP23573 studied in parallel Secondary Compare blood levels to those in the intravenous program showing anti-tumor activity Confirm mTOR inhibition by PD assays

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Oral Tablet AP23573 Clinical Trial – Objectives

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  1. Oral Tablet AP23573 Clinical Trial – Objectives • Primary • Determine safety, tolerability and MTD of multiple dose schedules of oral AP23573 studied in parallel • Secondary • Compare blood levels to those in the intravenous program showing anti-tumor activity • Confirm mTOR inhibition by PD assays • Describe anti-tumor activity • Characterize PK parameters Confidential

  2. Oral AP23573 Trial Status • 7 dose schedules studied in parallel • MTD identified • Over 125 patients treated • Majority of patients with a diagnosis of sarcoma • Evidence of mTOR inhibition using pharmacodynamic assay • Many patients with prolonged stable disease • On study 4-15+ months • Side effect profile consistent with i.v. • Mouth sores main DLT • Final dose schedule being optimized for highest cumulative dose and frequency of dosing together with tolerability to allow long-term use Confidential

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