June 24, 2008
Delcath Expands Multi-Center Phase III Trial for Metastatic Melanoma
Delcath Systems, Inc. (NASDAQ: DCTH) announced today that the University of Texas Medical Branch at Galveston (UTMB), part of the University of Texas System, has joined Delcath's Phase III clinical trial for the treatment of inoperable metastatic melanoma in the liver using the Company's Percutaneous Hepatic Perfusion (PHP) System for the isolated, high-dose delivery of the anti-cancer agent melphalan. UTMB is the sixth center in this multi-center study testing the Delcath System.
Delcath and UTMB have entered into a clinical research agreement to conduct the Phase III National Cancer Institute (NCI) led study. Orhan S. Ozkan, MD, Associate Professor of Radiology and Director of Vascular and Interventional Radiology, will serve as the Principal Investigator of the study. On joining this study, Dr. Ozkan commented, "We are excited about being a part of this clinical trial and being the first center to offer this treatment modality to patients in this region of the US. This treatment offers tremendous promise for patients suffering from metastatic melanoma in the liver, and we are pleased to be able to offer this option to our patients."
Over the past two months, Delcath Systems has added five cancer centers to this Phase III trial, which needs fewer than sixty additional patients to reach full enrollment. On the addition of UTMB to this study, Richard Taney, President and CEO of Delcath, stated, "We continue our efforts to make this treatment option available at leading cancer centers throughout the United States. Dr. Ozkan's participation will provide patients in the southwest region of the country access to this trial and provides an important treatment option for inoperable metastatic melanoma to the liver. The interest in PHP by the physicians treating this fatal condition continues to grow and we continue working to expand the geographic availability of our technology."
The Phase III Study
The Phase III study is designed to test Delcath's proprietary 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. 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 the University of Texas Medical Branch at Galveston
UTMB is a major academic health center dedicated to improving lives through health sciences education, clinical care and biomedical research. The University has six hospitals in Galveston, 90 campus- and community-based clinics, and four schools: medical, nursing, allied health sciences, and a graduate school for biomedical sciences. UTMB is the lead institution for the Western Regional Center of Excellence for Biodefense and Emerging Infectious Diseases and is the site of the Galveston National Laboratory, one of only two national biocontainment laboratories. Last year UTMB had $156 million in research expenditures with $105 million in NIH funding. Major research and patient care initiatives include a cancer center, a transplant center, molecular cardiology, burns care, neurology and the neurosciences, infectious disease, and women's and children's health. The University is the seventh largest employer among those headquartered in the Houston/Galveston region with 12,000 employees and a $1.4 billion budget. For more information, please visit the UTMB website at http://www.utmb.edu/
About Delcath Systems, Inc.
Delcath Systems is a developmental stage company testing its percutaneous perfusion technology for the isolated delivery of high doses of therapeutic and chemotherapeutic agents. The Delcath System is currently being tested with the drug melphalan in Phase III and Phase II clinical trials. The Company's intellectual property portfolio currently consists of twenty-eight 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.
Company Contact: Delcath Systems, Inc. Richard Taney (212) 489-2100 www.delcath.com Media Relations Contact: The Global Consulting Group Ivette Almeida Email Contact Investor Relations Contact: Strategic Growth International, Inc. Richard E. Cooper (212) 838-1444
SOURCE: Delcath Systems, Inc.