September 2, 2008
Delcath Cancer Trials Welcome New Principal Investigator From NCI
Delcath Systems, Inc. (NASDAQ: DCTH) announced today that the National Cancer Institute (NCI) has named Dr. Marybeth S. Hughes, MD as the Principal Investigator for the current Phase III and Phase II clinical trials of the Company's Percutaneous Hepatic Perfusion (PHP) System. These trials are being conducted under a Cooperative Research and Development Agreement (CRADA) between the NCI and Delcath. This announcement comes as Dr. James F. Pingpank, Jr., who was Principal Investigator of the trials while at NCI, has assumed the position of associate professor in the division of surgical oncology at the University of Pittsburgh School of Medicine. Dr. Pingpank has been named extramural Adjunct Principal Investigator for the ongoing trials at the NCI.
Dr. Marybeth Hughes, who has been Co-Investigator on these studies since 2004, will provide continued experience and leadership to the trials as the Phase III study treating metastatic melanoma in the liver continues to accelerate with the recent announcements that eight additional treatment centers have joined the trial.
The NCI continues to serve as the lead center for the multi-center Phase III trial and Steven A. Rosenberg, MD, PhD, Head, NCI Tumor Immunology Section and Chief, NCI Surgery Branch will continue in his role as Principal Investigator for all aspects of research under the Cooperative Research and Development Agreement (CRADA) between NCI and the Company.
On his recent move to UPMC, Dr. Pingpank stated, "UPMC is a recognized leader in the area of regional cancer therapies. I am delighted to join the team at The University of Pittsburgh Medical Center, and I look forward to continue working closely with Dr. Hughes, Dr. Rosenberg and NCI on these studies."
On these announcements, Richard L. Taney, President and CEO of Delcath, stated, "We are excited about these recent developments, and the continuation of our close working relationship with NCI and Dr. Hughes in her expanded role as Principal Investigator on the study. The NCI's commitment to the Delcath technology remains instrumental in identifying clinical and technological improvements to the PHP system and in training new physicians in the administration of PHP. We are also pleased to continue our relationship with Dr. Pingpank and look forward to working with him at UPMC towards completion of the Phase III trial and a variety of projects to expand the reach of Delcath's technology and establish PHP as a first-line treatment for liver cancers."
About Delcath Systems, Inc.
Delcath Systems, Inc. is a medical technology company specializing in cancer treatment. The Company has developed a proprietary, patented system which will improve the efficacy of cancer treatment while reducing the considerable, systemic side-effects of chemotherapy. Delcath's novel drug delivery platform is capable of delivering anti-cancer drugs at very high doses to a specific organ or region of the body 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-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 Email Contact Investor Relations Contact: Strategic Growth International, Inc. Richard E. Cooper/Cass Almendral (212) 838-1444 Email ContactEmail Contact Public Relations Contact: Rubenstein Associates, Inc. Robin Wagge (212) 843-8006 Email Contact
SOURCE: Delcath Systems, Inc.