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ELAD : Recent Clinical Data

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ELAD : Recent Clinical Data

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    1. ELAD®: Recent Clinical Data

    2. Conflict of Interest Statement ELAD® is NOT FDA approved The speaker is on the Board of Directors of Vital Therapies, the manufacturer of the ELAD ®

    4. Key to Success ELAD® C3A Cells Key is Proprietary C3A cell line Human: no animal or safety issues Stable: can be stored, grown in unlimited quantities and shipped worldwide with minimal bedside preparation Immortal: Retain hepatocyte functions for continuous treatment No regulatory impediments - FDA accepted CMC Cells located in space between hollow fibers in cartridge Plasma flows through hollow fibers of improved porosity Toxins processed and metabolites secreted across membrane to plasma

    6. ELAD® - A Decade of Progress: Therapeutic Advancements

    7. FHF Clinical Studies

    8. FHF Phase I: Bridge-to-transplant/recovery

    9. Combined Phase I/II: Survival

    10. ELAD® China Trial: Enrollment First randomized, controlled trial in Acute on Chronic Liver Failure patients Based on previous US and UK clinical trials of ELAD® in Fulminant Hepatic Failure patients Pivotal trial protocol approved by SFDA 90 patients at 2:1 69* patients enrolled (68 treated) Interim analysis at 49 patients Additional 20 run for safety and dose ranging on new protocol Intent-to-treat (ITT) analysis

    11. Contributors

    13. Bedside System in Operation at Beijing Youan Hospital

    14. ELAD® China Trial: Entry Criteria Inclusion Chronic HBV or HCV infection with acute liver failure episode Bilirubin 5x ULN INR > 1.6 Severe fatigue, anorexia or distention

    15. ELAD® China Trial Protocol: Patients 1- 49

    16. ELAD® China Trial Endpoints: Patients 1 - 49 28 and 84 day Transplant-Free Survival INR Changes in fatigue, anorexia and distension Biochemical values, MELD scores

    17. ELAD® China Trial: Data Presentation 69 patients enrolled (68 treated)* Divided into 2 groups Patients 1 - 49 Patients 50 – 69* All data presented is based on Intent-to-Treat (ITT) analysis.

    18. Demographics: Patients 1 - 49

    22. Transplanted Patients had Seriously Deteriorated

    24. MELD: Survivors only

    25. Safety and Treatment Events: Patients 1 - 49 Thrombocytopenia (p=0.15) Similar to other extracorporeal systems Liver failure patients have low platelets Platelet shortage in China led to bleeding in some patients Events more common in treated patients Ecchymosis (p=0.03) Transient fever (p=0.08) Peripheral edema (p=0.08) Ascites (p=0.18) Lung infection (p=0.23) Catheter site bleeding (p=0.23)

    26. ELAD ® China Trial Protocol: Last 20 Patients Patients 50 – 69*

    27. 28 Day Survival vs Duration 69 patients*

    28. Change in Platelet Count ELAD® patients

    29. ELAD® China Trial Conclusions: Patients 1 - 49

    30. CURRENT STATUS: JUNE 21 2008 Successful China pivotal trial at Youan and 302 Military Hospitals Treated patients have 84% 28-day survival rate vs. control group 50% SFDA approval application submitted in September 2007 U.S. safety trials to begin in 2Q 2008 Pivotal trial 2009 Cartridges supplied from VTI San Diego, California plant

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