Delcath Granted Japanese Patent for Delcath System.IP Portfolio Expanded and Updated To 28 Patents NEW YORK New York, state, United States New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of -- Delcath Systems, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :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 balloon catheter n. A catheter with an inflatable balloon at its tip, used especially to expand a partially obstructed blood vessel or bodily passage and to measure blood pressure in a blood vessel. Also called balloon-tip 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 See Liberate. ). 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 (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. 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 Liver Cancer Definition Liver cancer is a relatively rare form of cancer but has a high mortality rate. Liver cancers can be classified into two types. 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 Metastatic The term used to describe a secondary cancer, or one that has spread from one area of the body to another. Mentioned in: Coagulation Disorders metastatic pertaining to or of the nature of a metastasis. ocular and cutaneous cutaneous /cu·ta·ne·ous/ (ku-ta´ne-us) pertaining to the skin. cu·ta·ne·ous adj. Of, relating to, or affecting the skin. Cutaneous Pertaining to the skin. 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 ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. 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 FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. 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 Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored phase II , also underway at the NCI, is testing use of the Delcath System for the organ-specific delivery of the chemotherapeutic agent chemotherapeutic agent An agent used to treat CA, administered in 'regimens'-one or more 'cycles' that combine 3 or more agents over wks; CAs are toxic to any cell with a high rate of proliferation–the CA itself, the GI tract–causing N&V, 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 isolated hepatic perfusion Oncology A procedure for administering high dose chemotherapy only to the liver , 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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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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