DATA SAFETY MONITORING BOARD UNANIMOUSLY RECOMMENDS CONTINUATION OF DELCATH PHASE III CLINICAL TRIAL FOR INOPERABLE METASTATIC MELANOMA
NEW YORK – March 23, 2009 – Delcath Systems, Inc. (NASDAQ: DCTH), a medical technology company testing its proprietary Percutaneous Hepatic Perfusion (“PHP”) SystemTM for the treatment of cancers of the liver, announced today that the Data and Safety Monitoring Board (“DSMB”) reviewed clinical data on the first 51 patients enrolled in the Phase III clinical trial treating metastatic cutaneous and ocular melanoma to the liver.
The DSMB is an independent group of experts with the responsibility for reviewing and evaluating the safety and response data generated from the Company’s Phase III trial. The primary responsibilities of the DSMB are to ensure the safety of all patients enrolled in the trial, the quality of the data collected and the continued scientific validity of the trial design. The DSMB reviews data periodically in order to make an informed risk versus benefit recommendation concerning the continuation, modification, or termination of the trial due to safety concerns. This DSMB review was triggered upon recruitment of the 46th patient, marking the halfway point in this 92 patient trial.
After reviewing the data on more than one half of the required patients in this trial, the DSMB unanimously recommended that the trial continue to enroll patients with the goal of reaching the 92 patients required to complete the study. The current eleven participating cancer centers in this trial will continue to evaluate and enroll patients and the DSMB is slated to review updated clinical data following recruitment of the 69th patient, which would mark the 75% enrollment point for this trial.
The Phase III Study
The Phase III study is testing Delcath's PHP System for the regional delivery of melphalan to the liver to treat patients with metastatic ocular and cutaneous melanoma who have unresectable tumors in the liver. The Delcath System is designed to deliver significantly higher doses of anti-cancer drugs to a patient's liver while preventing entry of the drugs to the rest of the patient's circulation. This isolation limits toxicities that result from systemic chemotherapy treatments.
Patients in the Phase III trial initially are randomized into one of two treatment arms, including immediate treatment with melphalan via the Delcath System or treatment with best alternative care. The study is designed to evaluate the duration of tumor response in each of the two study arms. Following guidelines established by U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA), when disease progresses in patients enrolled in the best alternative care arm of the trial, they are permitted to "cross over" and receive treatment with the Delcath System.
About Delcath Systems, Inc.
Delcath Systems, Inc. is a medical technology company specializing in cancer treatment. The Company is testing a proprietary, patented drug delivery system for the treatment of liver cancers. Delcath's novel drug delivery platform is testing the delivery of ultra-high doses of anti-cancer drugs to the liver while preventing these high doses of drug from entering the patient's bloodstream. The Company is currently enrolling patients in Phase III and Phase II clinical studies for the treatment of liver cancers using high doses of melphalan. The Company's intellectual property portfolio consists of twenty-seven patents on a worldwide basis including the U.S., Europe, Asia and Canada. For more information, please visit the Company's website at www.delcath.com.
The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by the Company or on its behalf. This news release contains forward-looking statements, which are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to, uncertainties relating to our ability to successfully complete Phase III clinical trials and secure regulatory approval of our current or future drug-delivery system and uncertainties regarding our ability to obtain financial and other resources for any research, development and commercialization activities. These factors, and others, are discussed from time to time in our filings with the Securities and Exchange Commission. You should not place undue reliance on these forward-looking statements, which speak only as of the date they are made. We undertake no obligation to publicly update or revise these forward-looking statements to reflect events or circumstances after the date they are made.
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