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Delcath Systems Presents Positive Phase II Data on Delcath PHP System in Treatment of Inoperable Liver Metastases Overall Survival of 40 Months Suggests Significant Benefit from Targeting Unresectable Liver Metastases Using PHP System
Patients with diffuse liver disease face limited treatment options and are often given very poor prognoses. The Delcath PHP System was designed to isolate blood flow from the liver, deliver very high doses of anti-cancer agent, then filter a majority of the agent out of the blood from the treated area. This process allows patients with large and diffuse liver tumors to receive a concentrated, site-specific treatment where resection, ablation, and embolization are not feasible or have failed to halt spread of the cancer. In 24 patients who presented with diffuse liver metastases of pancreatic neuroendocrine and carcinoid tumors, a total of 68 treatments were administered. Of 19 evaluable patients, complete radiographic tumor responses were observed in 2 patients and partial responses were observed in 13 patients resulting in an objective tumor response rate of 79%. In addition, 1 minor response (21% tumor reduction with a duration of 43 months) was observed and only 1 of the 19 evaluable patients showed disease progression on therapy. Median overall survival, based upon an intention to treat analysis, was 40 months and median hepatic progression free survival for treated patients was 39 months. This update of the Phase II neuroendocrine trial data confirms the durable impact upon hepatic progression free survival and overall survival previously reported. Findings were presented in an oral session by lead author Dr. James Pingpank Jr., MD. of the Surgery Branch of the NCI at the National Institute of Health in Bethesda, MD. Delcath plans to submit a new trial protocol to the FDA seeking to establish the use of PHP as a first line treatment of metastatic neuroendocrine tumors. For more information about this and other studies of the Delcath PHP System in primary and secondary liver cancers, please visit www.livercancertrials.com. About Delcath Systems, Inc. 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. |