Delcath Systems, Inc. has announced that the first fifty percent (46 of 92) of patients have been enrolled in the Phase III clinical trial treating metastatic cutaneous and ocular melanoma to the liver.
The eleven participating cancer centers in this trial continue to evaluate and enroll patients and the Company looks forward to completing enrollment in 2009.
Commenting on this important event, Richard L. Taney, President and Chief Executive Officer of Delcath, stated, "Enrollment of the forty-sixth patient in this trial represents a significant milestone for our Company as we continue to accelerate this trial and accrue the data to support FDA approval of the Delcath PHP System. Attaining the midpoint of this trial, on the heels of expanding to eleven centers, is an important confirmation that the Company remains on the clinical and regulatory schedule discussed with investors over the past six months. The clinical data for the first 46 patients will be submitted to the Data Safety Monitoring Board for evaluation, once we complete the collection of follow-up data on the recently treated patients. We look forward to updating our investors during our upcoming conference call to be held next month."
This multi-center clinical study is being conducted under a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI). Under this CRADA, patients for this study are being treated at the NCI and at ten cancer centers throughout the United States. The NCI is serving as coordinating center for the study, which includes the initiation and training of the new clinical trial centers for this important trial. Plans under the CRADA include continuing patient enrollments and completing the clinical testing of PHP as treatment for these life threatening liver diseases.
The Phase III study is testing Delcath's PHP System for the regional delivery of melphalan to the liver to treat patients with metastatic cutaneous and ocular 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 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.