Delcath Adds the Cancer Center of Albany Medical Center to Phase III Trial for Metastatic Melanoma
Delcath Systems, Inc. (NASDAQ: DCTH) announced today that the Albany Medical Center has joined Delcath’s Phase III clinical trial for the treatment of inoperable metastatic melanoma in the liver using the Company’s Percutaneous Hepatic Perfusion (PHP) System for the isolated, high dose delivery of the anti-cancer agent melphalan. Albany Medical Center is the fourth center in this multi-center study.
Delcath is announcing this expansion of the trial following Albany Medical Center entering into a clinical research agreement with Delcath. Gary Siskin, M.D., Professor and Chairman of Radiology and Director of Interventional Radiology at the Albany Medical Center will serve as the Principal Investigator of the study. Dr. Siskin, a leader in the field of liver directed oncology therapies, commented, “Metastatic melanoma is a devastating disease with very poor patient prognosis, and I am pleased to be able to provide this new treatment option to patients who lack viable alternatives.”
The addition of Albany Medical Center to the trial, which follows the announcement earlier this week that St. Luke’s Cancer Center of Bethlehem, Pennsylvania has joined the trial, is expected to be followed by the announcement of additional centers in the coming months. Richard Taney, President and CEO, stated, “Delcath continues to expand the geographic reach of this Phase III study and we are excited to be working with Albany Medical Center and Dr. Siskin.”
The Phase III Study
The Phase III study is designed to test Delcath’s proprietary PHP System for the regional delivery of melphalan to the liver to treat patients with metastatic ocular and cutaneous melanoma who have unresectable tumors in the liver. The Delcath System is designed to deliver significantly higher doses of anti-cancer drugs to a patient’s liver while preventing entry of the drugs to the rest of the patient’s circulation. This isolation limits toxicities that result from systemic chemotherapy treatments.
Patients in the Phase III trial initially are randomized 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 U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA), 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 III study, which recently exceeded 33% enrollment, is expected to be completed in 2009, leading to an application to the US Food and Drug Administration (FDA) for commercial approval of the PHP System.
About Albany Medical Center
Albany Medical Center is the leading academic health sciences center in the twenty-five counties of Eastern New York and Western New England. The Center incorporates the 631-bed Albany Medical Center Hospital, one of New York’s largest teaching hospitals; Albany Medical College, one of the Nation’s first private medical schools; and the Albany Medical Center Foundation, Inc., one of the largest fund-raising organizations in the region.
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 with the drug melphalan in Phase III and Phase II 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 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, Inc.