SEC Filing - Delcath Systems, Inc.

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UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 7, 2005 DELCATH SYSTEMS, INC. (Exact name of registrant as specified in its charter) Delaware 001-16133 06-1245881 (State or other (Commission (IRS Employer jurisdiction of File Number) Identification No.) incorporation) 1100 Summer Street, Stamford, Connecticut 06905 (Address of principal executive offices) (Zip Code) Registrant's telephone number, including area code: (203) 323-8668 N/A (Former name or former address, if changed since last report) Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2 below): [ ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) [ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) [ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) [ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

2 Section 8 - Other Events Item 8.01 Other Events. On March 7, 2005, Delcath Systems, Inc. (the "Company") issued a press release relating to certain preliminary findings by National Cancer Institute researchers using the Company's technology. The Company's press release dated March 7, 2005 is incorporated herein by reference and filed as an exhibit hereto. Section 9 - Financial Statements and Exhibits Item 9.01 Financial Statements and Exhibits. (a) Not applicable (b) Not applicable. (c) Exhibits: Exhibit Description 99 Press Release dated March 7, 2005 of Delcath Systems, Inc.

3 SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. DELCATH SYSTEMS, INC. By: /s/ M. S. KOLY -------------------------------- M. S. Koly President and Chief Executive Officer Date: March 8, 2005

EXHIBIT INDEX Exhibit Description 99 Press Release dated March 7, 2005 of Delcath Systems, Inc.

NCI Researchers Report Survival and Tumor Results With Delcath Cancer Therapy ATLANTA, March 7, 2005 -- National Cancer Institute researchers said cancer treatment technology developed by Delcath Systems, Inc. (DCTH) was associated with positive anti-tumor activity in patients with inoperable cancer in the liver in a Phase I dose finding trial and increased overall median survival to 13 months compared to an average survival of 6-9 months for historical controls. The findings, which detailed a preliminary look at patients with metastatic melanoma in the liver, the largest subset of patients in the Phase I trial, were reported during the Melanoma Session at the Society of Surgical Oncology's 58th Annual Cancer Symposium, March 3-6 in Atlanta, GA, by NCI investigator Jeffrey Farma, MD, a colleague of the study's principal investigator H. Richard Alexander, MD, head of the NCI's Surgical Metabolism Section. As a follow-up to a presentation at a cancer symposium in Florida in late January 2005, the NCI reported that five of the 15 evaluable patients in the Delcath study have lived longer than 15 months, and one remained alive past 20 months. The survival data is expected to improve as investigators continue follow-up of living patients. Patients diagnosed with inoperable cancer in the liver experience an average survival time of six to nine months, based on historical data. The NCI said two-thirds of the 15 patients exhibited anti-tumor activity ranging from stabilization to a complete response. Of those, 50 percent experienced tumor mass reduction of 50 percent or more. The findings were based on radiographic measurement. Dr. Alexander's research team at the NCI has since started Phase II clinical studies with the Delcath technology to develop further data on safety and efficacy for eventual applications to the FDA for marketing approval. "The NCI's findings continue to contribute to a strong foundation of positive clinical outcomes with our technology and to its value in treating patients with terminal tumors," said Delcath chief executive officer M. S. Koly. "In addition to continuing follow-up with Phase I patients, Dr. Alexander has informed Delcath that he intends to perform an analysis on quality of life in the recently launched Phase II trial, contrasting the effects of the Delcath therapy on these patients to those experienced by patients undergoing the only current alternative therapies, which are protracted courses of chemotherapy that are extremely toxic and difficult to get through." "There was broad interest generated by the meeting, with a lot of questions asked by the oncologists about the therapy and results." Dr. Alexander reported to the company.

2 "Good questions were asked and there was encouragement to continue clinical trials to determine the optimal clinical setting to get the maximum benefit." The Delcath system delivers chemotherapy directly to the liver via the hepatic artery at much higher doses than is possible with traditional intravenous therapy. As blood exits the liver, special Delcath filters trap the chemotherapy, protecting the rest of the body from excessive toxicity. The procedure is repeatable and less invasive than traditional ways of performing isolated perfusion to effect high-dose therapy of specific body organs or regions. About Delcath Delcath is a developer of isolated perfusion technology for organ or region-specific delivery of therapeutic agents. Six US and three foreign issued patents cover its technology. The company is headquartered in Stamford, CT. This release contains "forward-looking statements" based on current expectations but involving known and unknown risks and uncertainties. Actual results or achievements may be materially different from those expressed or implied. Delcath plans and objectives are based on assumptions involving judgments with respect to future economic, competitive and market conditions, its ability to consummate, and the timing of, acquisitions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond its control. Therefore, there can be no assurance than any forward-looking statement will prove to be accurate.