1 SARC011 Biology Protocol Lee J. Helman, M.D. SARC Biannual Meeting London, Nov 13, 2008.

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1 SARC011 Biology Protocol Lee J. Helman, M.D. SARC Biannual Meeting London, Nov 13, 2008

2 Reminder-How to select patients most likely to respond! Status Update As of Nov 1, Pts entered on SARC have consented to CBP 16 of 28 sites have opened CBP-others in process

3 Trial Centers USA Trial Centers USA Trial Centers EU Trial Centers EU Trial Centers USA Trial Centers EU Leiden P. Hogendoorn MSKCC M Ladanyi C. Antonescu Histogenix: IHC assays as per protocol Confirm histopathology; assess translocations 30 unstained FFPE tumor tissue slides Barcoded slides SARC011 Sample Flow: Tissue Blocks / Sections for Confirmation of Diagnosis Slides to NCI for Genetic Analysis Roche Basle CSO Roche Nutley CSO 30 unstained FFPE tumor tissue slides Anticipate receiving ~20 unstained tissue slides for each patient from path labs

4 Trial Centers USA Trial Centers USA Trial Centers EU Trial Centers EU Trial Centers USA Trial Centers EU Basel CSO Ligands, shed receptor Clinical database 3 x 1mL aliquots frozen serum Barcoded serum samples SARC011 Sample Flow: Serum 3 x 1mL aliquots frozen serum Results All clinical sites to ship serum samples to Roche Central Sample Office (shipping materials provided by Roche) Bioanalytics and serum PD assays to be conducted at CSOs and data submited to central clinical database Nutley CSO

5 Status of Assays IHC assays for IGFI-R, pAkt, pErk, pmTOR, PTEN released RT-PCR assays being standardized ELISA assay for serum IGF-I levels running Decision made to not perform: –Shed IGF1-R –pIGF1-R IHC (assay not performing) 12 tissue samples received at NCI for full length IGF1-R seq (limited set), LOI IGF2, p53 and RAS hotspot sequencing, p15/16 deletion