Delcath Systems, Inc. announced that the Atlantic Melanoma Center of Atlantic Health 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. Atlantic Health is the fifth centre in this multi-centre study testing the Delcath System.
Delcath and Atlantic Health have entered into a clinical research agreement to join the National Cancer Institute (NCI) led study. Eric Whitman, MD, FACS, director, Atlantic Melanoma Center and medical director, office of grants and research, will serve as the principal investigator of the study. The PHP treatments will be performed at Morristown Memorial Hospital, in Morristown, New Jersey, part of Atlantic Health.
Dr Whitman brings many years of experience in melanoma and clinical research to this trial, and has been at the forefront of initiating new and promising technologies at his institution. On joining this trial, Dr Whitman said, "I am very pleased to be able to enrol patients in this phase III trial for metastatic melanoma, a disease for which an effective treatment has eluded us. Delcath's PHP System shows tremendous promise in its application to this indication, and I look forward to offering this new treatment to my patients".
Delcath Systems continues adding cancer centres to this phase III trial, which has accrued one-third of the required ninety-two patients. On this recent expansion to include Atlantic Health, Richard Taney, president and CEO of Delcath, stated, "The Delcath System is now available at a number of leading cancer centres. Delcath continues working to reach its stated goals of expanding this phase III trial and increasing physician awareness of the Delcath PHP System in order to improve the availability of this treatment to patients diagnosed with inoperable metastatic melanoma to the liver. We will continue to add centres to this trial, and hope to complete enrolment in 2009".
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 tumours 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.
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 tumour response in each of the two study arms. Following guidelines established by US 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 per cent enrolment, 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.