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Incidence of Hypophosphatemia

Incidence of Hypophosphatemia. 15a - 70. Patients with GI Bleeds and Proton Pump Inhibitors (PPI) – NDA SU. All GI bleeds 79 PPI at anytime on-study 62 (78%) PPI at baseline 16 (20%) Relevant medical history 4 (5%). 12c - 6. Dasatinib Exposure: Dose Proportionality.

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Incidence of Hypophosphatemia

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  1. Incidence of Hypophosphatemia 15a - 70

  2. Patients with GI Bleeds and Proton Pump Inhibitors (PPI) – NDA SU • All GI bleeds 79 • PPI at anytime on-study 62 (78%) • PPI at baseline 16 (20%) • Relevant medical history 4 (5%) 12c - 6

  3. Dasatinib Exposure: Dose Proportionality • Dasatinib Exposure vs Dose with B7D Regimen • Study 002 – MAD study; 84subjects with CML • At dose levels of 50–120 mg BID, the exposure increase was slightly more than dose proportional at steady state 25 - 1

  4. Chronic Phase CML – Study 002 Major Cytogenetic Responses in Imatinib-resistant Patients in Phase I 23 - 4

  5. Mechanism of Action of Pleural Effusion • Likely related to the inhibition of PDGF-β • PDGF-β regulates interstitial fluid homeostasis in mouse model(Heuschel et al, PNAS 1999) • Fluid retention described with other drugs known to inhibit PDGF-β • e.g. Imatinib, CDP860 (humanized antibody) 13c - 2

  6. Study 017 Pretreatment Characteristics 24 - 2

  7. Study 017 Patient Disposition 24 - 3

  8. Study 017 Efficacy 24 - 4

  9. Study 017 Major Cytogenetic Response at 3 Months Percent Responders N = 74 33 63 34 39 15 24 - 5

  10. Study 017 Time to Treatment Failure Dasatinib Imatinib + + Censored Months 24 - 12

  11. Study 017 Non-Hematological Adverse Events 24 - 7

  12. Study 017 Myelosuppression 24 - 8

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