![]() |
|
DELCATH EXPANDS PHASE III TRIAL FOR METASTATIC MELANOMA TO FLORIDA Moffitt CANCER CENTER JOINS TRIAL TREATING INOPERABLE CANCERS NEW YORK July 24, 2008 Delcath Systems, Inc. (NASDAQ: DCTH) announced today that Moffitt Cancer Center (Moffitt), a National Cancer Institute Comprehensive Cancer Center, has joined Delcaths Phase III clinical trial for the treatment of inoperable metastatic melanoma in the liver using the Companys Percutaneous Hepatic Perfusion (PHP) System for the isolated, high dose delivery of the anti-cancer agent melphalan. Moffitt is the seventh center in this multi-center trial using the Delcath System.
Delcath and Moffitt have entered into a clinical research agreement to conduct the Phase III National Cancer Institute (NCI) led study. Jonathan S. Zager, MD, Assistant Professor of Surgery in the Department of Oncologic Sciences and a member of the Division of Cutaneous Oncology at Moffitt will serve as the Principal Investigator of the study. On joining this study, Dr. Zager commented, This is a tremendous opportunity for Moffitt and our patients to be able to enroll in this trial. Metastatic melanoma is a devastating disease, providing limited treatment options and resistant against most therapies. This trial provides hope and promise to patients suffering from this disease and we look forward to being able to assist in the enrollment process and bettering our patients prognoses.
Commenting on Moffitt joining this trial, Richard L. Taney, President and CEO of Delcath, stated, Our expansion of this trial continues and we are very excited to be able to enroll patients at Moffitt under the leadership of Dr. Zager, who brings broad experience in melanoma and clinical research to this study. By working with leading melanoma physicians and centers, such as Dr. Zager and Moffitt, we are increasing the availability of this treatment option to more geographic regions and patients. We will continue our efforts to broaden the reach of this trial through the addition of recognized cancer centers, make this treatment option available to as many patients as possible, and to reach our goal of completing trial enrollment in 2009.
The Phase III Study
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. The Phase III study, which recently exceeded 33% enrollment, is expected to be completed in 2009, leading to an application to the US Food and Drug Administration (FDA) for commercial approval of the PHP System.
About H. Lee Moffitt Cancer Center & Research Institute
About Delcath Systems, Inc.
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.
|