Healthcare Industry News: melphalan
News Release - May 30, 2007
Delcath Systems Receives National Cancer Institute Approval to Expand Phase III Trial to Multiple Centers
Additional Clinical Centers Can Participate in Testing the Delcath System for Inoperable Liver CancerSTAMFORD, Conn.--(HSMN NewsFeed)--Delcath Systems, Inc. (Nasdaq:DCTH ) was informed today that the National Cancer Institute ("NCI") Institutional Review Board ("IRB") has approved the expansion of the Company's ongoing Phase III trial to include additional clinical centers. The NCI is currently the only center treating patients in the Phase III pivotal trial of the Delcath System for the region-specific delivery of the chemotherapeutic agent, melphalan, to patients with metastatic melanoma in the liver. The NCI will continue to treat patients and, under the terms of the recently signed Cooperative Research and Development Agreement ("CRADA") between the Company and the NCI, it will additionally serve as the coordinating center for the multi-center trial. Delcath has previously announced that the trial is approved for expansion to a maximum of 15 centers by the U.S. Food and Drug Administration ("FDA").
Commenting on today's announcement, Richard L. Taney, Chief Executive Officer of Delcath Systems, said, "We appreciate the NCI IRB granting approval to expand our Phase III trial into a multi-center trial as this action opens the door for the acceleration of patient enrollment and advancement of the Delcath System toward commercialization. We are actively recruiting a number of top oncology centers and look forward to their participation with the NCI in this important trial. By expanding the number of physicians using the device, we will speed protocol completion and benefit from the experience and comments of these leading clinicians as they use the Delcath System to treat their critically ill patients. We look forward to the day when this promising regional therapy is available to cancer patients who currently have limited treatment options and consequently, poor clinical prognoses."
The Phase III study is enrolling patients with metastatic ocular and cutaneous melanoma who have unresectable tumors in the liver, using the Delcath System to deliver the drug, melphalan. The Delcath System isolates the blood flow within the patient's liver in order to allow significantly higher doses of melphalan to be administered while limiting the toxicities that result from current 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 the guidelines established by FDA under a Special Protocol Assessment ("SPA"), when the disease progresses (tumor grows) in patients receiving best alternative care, they are allowed to "cross over" and receive treatment with the Delcath System.
About the National Cancer Institute
The National Cancer Institute, established under the National Cancer Institute Act of 1937, is the U.S. federal government's principal agency for cancer research and training. The NCI coordinates the National Cancer Program, which conducts and supports research, training, health information dissemination and other programs with respect to the cause, diagnosis, prevention and treatment of cancer, rehabilitation from cancer, and the continuing care of cancer patients and their families.
About Delcath Systems, Inc.
Delcath Systems is a developer of percutaneous perfusion technology for organ or region-specific delivery of therapeutic and chemotherapeutic agents. The Delcath System is currently being tested with the drug melphalan in a Phase III trial of patients with metastatic ocular and cutaneous melanoma in the liver and a Phase II trial of patients with primary liver cancers and metastatic tumors in the liver from neuroendocrine cancers and adenocarcinomas. The Company's intellectual property portfolio currently consists of 12 patents on a worldwide basis, including the U.S., Europe, Asia and Canada. For more information, please visit the Company's website www.delcath.com.
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.
Source: Delcath Systems
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