`School of Medicine
`
`University of Pennsylvania Health System
`654 BRB mm
`42] Curie Blvd
`
`Philadelphia, PA 19104
`TEL: 215-573-4176
`FAX: 215-573-8606
`
`MEMORANDUM
`
`To:
`
`Data Safety Monitoring Board Members
`Peter Adamson, MD (Chair)
`Roger Illingworth, MD
`Frederick Nunes, MD
`
`From:
`
`Daniel J. Rader, MD
`
`Date:
`
`February 9, 2004
`
`Re:
`
`Title:
`
`Data from 6 enrolled patients
`
`A Phase 11 Open Label, Dose-Escalation Study to Determine the Safety, Tolerability and
`Efficacy of Microsomal Triglyceride Transfer Protein (MTP) Inhibitor BMS-201038 in
`Patients with Homozygous Familial Hypercholesterolemia (Protocol No. UP 1001)
`
`Please find enclosed the following appendices describing the available clinical data of 6 patients enrolled in the above
`reference protocol.
`
`Appendix 1: Subject Demography at Baseline
`Appendix 2: Extent of Exposure to Study Drug BMS-201038
`Appendix 3: Vital Signs Listing
`Appendix 4: Pulmonary Function Tests and NMRS/MRI of the Liver by Subject
`Appendix 5: Listing of Adverse Events by Subject
`Listing of All Reported Clinical and Laboratory Adverse Events
`Appendix 6: Listing of Adverse Events by Event
`Listing of All Reported Clinical and Laboratory Adverse Events
`Appendix 7: Listing of Laboratory Parameters by Subject
`Appendix 8: Percent Change in Total Cholesterol at the End of Each Treatment Dose Compared to Baseline
`Appendix 9: Percent Change in Non-I-IDL Cholesterol at the End of Each Treatment Dose Compared to Baseline
`Appendix 10: Percent Change in Apolipoprotein B at the End of Each Treatment Dose Compared to Baseline
`Appendix 1 1: Fat Soluble Vitamins and Fatty Acid Profile in Subjects Receiving BMS-201038
`
`Please do not hesitate to contact me if you have any questions or require additional information. We thank you for your time
`in serving on the DSMB for this study and are excited by the efficacy and reasonable tolerability of this MTP inhibitor
`compound in these homozygous Fl-I patients.
`
`1 of 42
`
`PENN EX. 2082
`CFAD V. UPENN
`
`IPR2015-01836
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