Treating Unresectable Liver Metastases From Melanoma - Investigator Presents On Delcath Systems Phase III Trial Experience

Main Category: Liver Disease / Hepatitis
Also Included In: Cancer / Oncology;  Melanoma / Skin Cancer
Article Date: 07 Oct 2008 - 4:00 PDT

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Delcath Systems, Inc. (NASDAQ: DCTH) reported that the Adjunct Principal Investigator for its Phase III clinical trial, James Pingpank, Jr., MD, discussed interim results from its randomized study of high-dose melphalan, delivered via the Company's Percutaneous Hepatic Perfusion (PHP) system, in patients with inoperable liver metastases from melanoma. Dr. Pingpank's presentation entitled "Targeted Chemotherapy: Minimally Invasive Percutaneous Hepatic Perfusion" was made on Saturday, October 4 at the "Perspectives in Melanoma XII" Meeting in The Hague, The Netherlands.

During his presentation at this prestigious conference, Dr. Pingpank stated: "The results that we have seen to date are tracking the response rates that we observed in the phase I trial of patients treated for metastatic melanoma in the liver with Percutaneous Hepatic Perfusion." Dr. Pingpank also discussed early results from the melanoma arm of the Company's Phase II trial, which is limited to patients who had previously received surgical isolated regional delivery of melphalan. Dr. Pingpank reported: "Of the five patients treated to date in the Phase II melanoma trial, we have observed a 100% response rate. All of these are durable partial responses."

Dr. Pingpank treated the largest number of patients in Delcath's Phase III Trial while at the National Cancer Institute (NCI). This ongoing study was recently expanded to include ten leading cancer centers throughout the United States. The Phase III trial of 92 patients is comparing Progression Free Survival (PFS) in patients treated with the Delcath PHP System to a control arm receiving Best Available Care (BAC). Following completion of the Phase I trial in 2003, the FDA granted Fast Track review status and advanced the Phase I trial directly to the Phase III trial. The trial, which is governed by a Special Protocol Assessment (SPA) with the FDA, seeks to demonstrate responses in PHP patients of at least 7.8 months, versus an expected response of four months or less in patients receiving BAC.

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 http://www.delcath.com.

This release contains express or implied forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are based on the current belief of management. These statements relate to, among other things, the results to date of our phase III clinical trials as described above. These statements are neither promises nor guarantees, but are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. In particular, the risks and uncertainties include, among other things: risks that any results of any trials to date are interim and may not be borne out or supported by subsequent or final results or that any such trials may not be fully completed as necessary; risks relating to our ability to further advance the development of the our system in clinical trials; risks of any failure to comply with regulations relating to our system, including FDA requirements; risks of failure to obtain the financial resources to complete development of our system; the risk that the FDA may interpret the results of our studies differently from any interpretation we may have; the risk that Dr. Pingpank's discussion as described above or elsewhere does not necessarily represent the position of or any information on behalf of Delcath, since he is not an employee, consultant or agent of or otherwise authorized to speak on behalf of Delcath, and all of the other risks discussed from time to time in our filings with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q. 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.

Delcath Systems, Inc.

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