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Anthony Tolcher Director of Clinical Research Institute for Drug Development CTRC, San Antonio TX

Phase I Drug Development: Early Indications of Antitumor Activity for Sarcoma Patients and Opportunities for Progress. Anthony Tolcher Director of Clinical Research Institute for Drug Development CTRC, San Antonio TX. Phase-1-ologist. Pronounced: faez ·won·ole·geest Definition:

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Anthony Tolcher Director of Clinical Research Institute for Drug Development CTRC, San Antonio TX

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  1. Phase I Drug Development:Early Indications of Antitumor Activity for Sarcoma Patients and Opportunities for Progress Anthony Tolcher Director of Clinical Research Institute for Drug Development CTRC, San Antonio TX

  2. Phase-1-ologist Pronounced: faez·won·ole·geest Definition: 1small curious creature that inhabits Texas, Ohio, California, and occasionally Arizona. 2Exhibits animated activity when exposed to novel chemical structures or mechanisms of action 3Becomes ecstatic if one patient in 40 has response

  3. Conventional Wisdom • Focus on main indications • Breast, lung, colon, maybe prostate • Smaller pharma- quickest route to NDA • unmet need, or accelerated approval • Serendipity versus screening • Apriori, cannot predict activity • If we fail to have sarcoma patients, it is hard for us to convince sponsors to explore sarcoma as an indication

  4. AP23573- Phase I May 18 2004 Sep 15 2004

  5. AP23573 Phase I 34 yr old female with GIST Refractory to Gleevec, ET743 and others

  6. Activity in Phase I Meaningful for Some Agents Regulatory Success from phase I activity • Iressa: NSCLC activity phase I • colon intended as indication • Contrast Tarceva • Irinotecan: persistent SD in colorectal • Gemcitabine: pancreas

  7. Integrated Proliferation/Apoptosis Targets TRAIL TNTC TRM1 ETR2 CCI 779 AP23573 DR4/5 R115777 YM155 Oblimersen Adapted from Johnstone et al. Cell. 2002.

  8. Survivin MFH TRAIL R1 TRAIL R2 Durable SD PDGFR c-Met Multi-targeted TKi Integrins mTOR IGFR Considerable literature PARP Kinesin 1 inhibitors Aurora Kinase Inhibitors Polo kinase inhibitors C-myc Current Phase I Targets

  9. Opportunities for Strategic Collaborations • Sarcoma patients account for 10% or less of IDD phase I population (500 yr) • Serendipity or screening? • Can we increase “chance” to see activity • Known targets in sarcoma subtypes • Direct patients to studies • Early identification of activity, rapid dissemination to phase II through affiliation

  10. Create a Relationship • Activity seen in phase I (sarcoma pt) • Rapid access network of phase II sarcoma investigators to conduct study • Accrual remains a serious concern • Need to be “problem-free” • Quality of data remains the key

  11. Referrals • This is key • Early Screen / serendipity • 40% of our patients come from southern USA • Good performance status, adequate organ function • Help from patient advocates • Opportunities for patients looking for expt options

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