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Delcath Granted Japanese Patent for Delcath System
Friday, November 30, 2007
IP Portfolio Expanded and Updated To 28 Patents
New York, NY -- Delcath Systems, Inc. (Nasdaq: DCTH) announces that it has been granted Japanese Patent No. 511694, securing a patent describing a modification to Delcath’s original patented, double-balloon catheter, which allows for the uninterrupted flow of blood to the heart while the patient receives a treatment with the Delcath System. This announcement follows Delcath’s recent and successful efforts to extend its patent protection broadly in Europe and Asia. Delcath has expanded and updated its overseas portfolio to include twenty patents for the Delcath System, in addition to its eight U.S. patents.
The recent Japanese patent secures the same intellectual property protection as Delcath’s rights under US Patent 5,893,841 titled, Balloon Catheter with Occluded Segment Bypass, and similar patents previously secured in Canada and selected countries in Europe. This invention describes the device currently being tested in Delcath’s Phase III and Phase II trials at the National Cancer Institute (NCI). Additionally, Delcath currently has six pending foreign patent applications.
Delcath’s intellectual property strategy is designed to address the increasingly competitive nature of the medical device and biotechnology markets, and is an integral part of the Company’s overall strategy to protect and advance its core technology. Commenting on this, Richard Taney, President and CEO of Delcath Systems, stated that, "Delcath continues to invest in the technological advancement of the Delcath System by exploring improvements to the current system as well as investigating new applications for our technology. Liver cancer is a worldwide epidemic, and we are positioning the Delcath System to address this unmet need while strengthening our proprietary assets. The high incidence of hepatitis and liver cancer throughout Asia makes our Japanese patent especially important as we explore opportunities in that market. We will continue to seek patents for modifications to our technology as we strive to improve the Delcath System."
The Phase III Trial
The Phase III study, currently underway at the NCI is testing the Delcath 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 isolates the blood flow within the patient’s liver in order to allow significantly higher doses of anti-cancer drug to be administered to the targeted disease 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 guidelines established by FDA under a Special Protocol Assessment, 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 II Trial
The Phase II clinical trial, also underway at the NCI, is testing use of the Delcath System for the organ-specific delivery of the chemotherapeutic agent melphalan in patients with specific tumors in the liver, including primary liver cancer, metastatic neuroendocrine tumors, adenocarcinomas in the liver, and metastatic melanoma in the liver of patients who previously received isolated hepatic perfusion, but whose cancer has since returned.
About Delcath Systems, Inc.
Delcath Systems is a developmental stage company testing its percutaneous perfusion technology for the isolated organ and region specific delivery of therapeutic and chemotherapeutic agents. The Delcath System is currently being tested with the drug melphalan in Phase III and Phase II human 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.
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