Healthcare Industry News: neuroendocrine tumor
News Release - May 20, 2008
Delcath Updates Phase III Patient Enrollment as Pivotal Trial Accelerates, Durable Tumor Responses In Phase II Study Also CitedNEW YORK, May 20 (HSMN NewsFeed) -- Delcath Systems, Inc. (Nasdaq: DCTH ) announced that Richard Taney, President and Chief Executive Officer, provided an update on enrollment numbers in the Company's pivotal Phase III clinical trial today at a gathering of financial and healthcare industry leaders attending the Rodman & Renshaw 5th Annual Global Healthcare Conference.
Mr. Taney's comments updated patient recruitment levels for the Phase III clinical trial of the Company's Percutaneous Hepatic Perfusion (PHP) technology for inoperable cancers in the liver. Enrollment in this pivotal trial, which is treating patients with metastatic melanoma, now totals 32 patients which surpasses one-third of the 92 patients required to complete enrollment of the trial. This represents an acceleration in patient enrollment in this NCI-led multi center trial, and occurs before accrual has begun at the first additional trial site which is the University of Maryland Medical Center.
Although the company is prevented from commenting on results from the randomized Phase III trial, Mr. Taney was able to update the audience on the parallel Phase II trial for patients with metastatic melanoma in the liver who had previously received surgical isolated regional therapy and are therefore ineligible for admission to the pivotal Phase III study. All five of the patients treated in this arm to date have shown responses to PHP and four of the five (80%) have shown objective tumor responses of 30% or greater reduction in tumor size.
Mr. Taney also discussed the metastatic neuroendocrine arm of Delcath's ongoing Phase II trial. This study was the subject of a well-attended presentation during the American Hepato Pancreato Biliary Association Annual Meeting in March of this year. At that meeting, NCI investigators reported a 79% overall response rate in the 23 evaluable patients, including two complete responses. In addition to reporting an unprecedented rate of response in this patient group, the median hepatic progression free survival was reported to be 39 months.
The presentation was webcast live and will be available for ninety days and accessible at http://www.delcath.com .
About Delcath Systems, Inc.
Delcath Systems is a developmental stage company testing its percutaneous perfusion technology for the isolated delivery of high doses of therapeutic and chemotherapeutic agents. The Delcath System is currently being tested in Phase III and Phase II clinical trials for the treatment of hepatocellular carcinoma and metastatic tumors in the liver, including melanomas, neuroendocrine tumors and adenocarcinomas. 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.
Source: Delcath Systems
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