NEW YORK and STOCKHOLM--26 Sep--PRNewswire-AsiaNet/InfoQuest
March 2011 Data Confirm Strong Treatment Effect of Chemosaturation
Delcath Systems (NASDAQ: DCTH) announced today that James F. Pingpank, MD, FACS, Associate Professor of Surgery at the University of Pittsburgh School of Medicine, will present updated investigator results from the Phase 3 randomized trial of Delcath's chemosaturation system with melphalan in patients with hepatic metastases from ocular or cutaneous melanoma.
Dr. Pingpank, a lead principal investigator of the Phase 3 trial, will present the abstract (9304), "Percutaneous Hepatic Perfusion (PHP) vs. Best Alternative Care (BAC) for Patients with Melanoma Liver Metastases - Efficacy Update of the Phase 3 Trial," in the plenary session today at 11:15am CEST at the European Multidisciplinary Cancer Congress in Stockholm. These updated results include follow-up data from patients through March 2011, an additional 12 months of data maturation from when Dr. Pingpank first presented investigator data from this Phase 3 trial in June 2010, at the American Society of Clinical Oncology's Annual Meeting.
With respect to the study's primary endpoint of hepatic progression free survival ("hPFS"), the updated investigator-assessed results showed that patients in the chemosaturation arm demonstrated median hPFS of 8.0 months compared to 1.6 months in the BAC arm, a significant 6.4 month extension of hPFS (hazard ratio 0.35, p