Delcath Systems, Inc. · NASDAQ:DCTH
Delcath Systems — World Conference on Interventional Oncology 2007
18 slides from Delcath Systems's conference presentation, May 16, 2007
Slide 1: Analysis of Clinical Toxicity in Patients Undergoing Percutaneous Intra-Arterial Hepatic Perfusion
Analysis of Clinical Toxicity in Patients Undergoing Percutaneous Intra-Arterial Hepatic Perfusion (PHP) with Melphalan for Unresectable Hepatic Malignancies J. F. Pingpank1, R. E. Royal1, H. R. Alexander2, M. K. Horne3, B. J. Wood4, Z. Neeman4, A. W. Kam4, S. K. Libutti1, M. S. Hughes1, U. S. Kammu
Slide 2: Disclosures
Disclosures This research is supported by NCI Intramural Research funding and an extensive CRADA agreement between Delcath Systems, Inc. and the Surgery Branch of the NCI.
Slide 3: Rationale for Regional Therapy
Rationale for Regional Therapy Regional therapy allows dose escalation to the cancer-bearing region or organ of the body while minimizing systemic exposure and toxicity, via complete separation of the regional and systemic circulation Eliminates or significantly reduces systemic toxicity, and dose e
Slide 4: Treatment of Hepatic Metastases: Rationale for Regional Therapy
Treatment of Hepatic Metastases Rationale for Regional Therapy Unresectable cancers (primary or metastases) confined to liver are a significant clinical problem: Colorectal cancer: 30,000/yr Hepatocellular carcinoma: 16,000/yr Ocular melanoma: 2,000/yr Neuroendocrine tumors: 2,000/yr Other histologi
Slide 5: Background: Isolated Hepatic Perfusion
Background: Isolated Hepatic Perfusion Colorectal Metastases n=120 pts RR: 60%, Median OS: 17.4m Ocular Melanoma Metastases n=29 pts RR:62%, Median OS: 12.1 m Neuroendocrine Metastases n=13 pts RR: 50%, Median OS: 48 m
Slide 6: Delcath Systems double balloon IVC catheter
Delcath Systems double balloon IVC catheter
Slide 7: Percutaneous Hepatic Perfusion
NCI 01-C-0215 Percutaneous Hepatic Perfusion
Slide 8: Protocol Schema
Protocol Schema On Study Evaluation Interval Evaluation Post Treatment Evaluation Treatments 1 and 2 Treatments 3 and 4 - Melphalan - Melphalan - Angiogram (Celiac, SMA) - Angiogram (Celiac, SMA) - GDA assessment (Treatment #1) - GDA assessment 4 Weeks 4 Weeks 4 Weeks 4 Weeks 16 weeks
Slide 9: Chemotherapy Levels During Therapy
Chemotherapy Levels During Therapy
Slide 10: Results: Toxicity
Results: Toxicity (198 Treatments) Mean Melphalan Dose at 3.0 mg/kg: 180 mg (126-220) Unsuccessful Therapy Hepatic artery dissection (n=2) Sclerotic hepatic artery (n=3) Hepatic venous anomaly (n=3) Toxicity (Grade III/IV) Neutropenia: 120 (60.6%) Thrombocytopenia: 96 (48.5%) Anemia: 36 (18%) Hepati
Slide 11: Results: Patient Demographics
Results: Patient Demographics Patients: 76 Number of Treatments: 198 Unsuccessful Treatments: 8 Histology: Melanoma: 26 Neuroendocrine: 19
Slide 12: Results: Complications
Results: Complications (198 Treatments) Arterial or Venous Catheters Hepatic Artery Dissection (n=2) Cervical Hematoma (n=1) Pneumothorax (n=1) Bleeding Intrahepatic (Tumor) Hemorrhage (n=1) Excessive Menstrual Bleeding (n=2) Gross Hematuria (n=1) Other Heparin Induced Thrombocytopenia (n=1) Transie
Slide 13: PHP for Patients with Metastatic Melanoma
PHP for Patients with Metastatic Melanoma Radiographic Treatment Response (n=16) Response n % Duration Overall 8 50 Complete 2 13 10, 15 Partial 6 37.5 2+,8, 8, 12, 15, 16 Stable Disease 4 25 7, 7, 8, 8+ Progressive Disease 4 25 Follow-up Status AWDb 1 6 DOD 15 94 Site of Disease Recurrence/Progress
Slide 14: Metastatic Glucagonoma
Metastatic Glucagonoma 54 year-old female Metastatic pancreatic neuroendocrine tumor Primary in place, treated post PHP with XRT PHP#1 PHP#2 XRT
Slide 15: Metastatic Glucagonoma
NCI 01-C-0215 Metastatic Glucagonoma Pre-Treatment Post-PHP x 2 Follow-up (22m) April 2003 November 2003 March 2005
Slide 16: Conclusions
Conclusions This strategy allows for the delivery of high-dose, intra- arterial cytotoxic chemotherapy with manageable regional and systemic toxicity Regional delivery of chemotherapy paired with hemofiltration allows for an increased therapeutic index for cytotoxic agents such as melphalan PHP with
Slide 17: Future Directions
Future Directions Metastatic Ocular Melanoma Phase III random-assignment trial vs. Best alternative care Primary endpoint: Hepatic DFS (cross-over permitted) Conversion to multi-center trial Metastatic Neuroendocrine Tumors Phase II trial, completion of second stage, expand to multicenter phase II H
Slide 18: Acknowledgements
Acknowledgements Surgery Branch Interventional Radiology Steven Libutti, MD Brad Wood, MD Richard Royal, MD Ziv Neeman, MD Mary Beth Hughes, MD Anthony Kam, MD Udai S. Kammula, MD Richard Chang, MD Cynthia Helsabeck Susan Ohl Geoffrey Seidel Perfusionists Tatiana Beresnev, MD Carol Pentol Mary Ann T
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