NEW YORK, Dec. 11 /PRNewswire-FirstCall/ -- Delcath Systems, Inc. (Nasdaq: DCTH), a medical technology company testing its proprietary Percutaneous Hepatic Perfusion ("PHP") System for the treatment of cancers of the liver, announced today 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
|SOURCE Delcath Systems, Inc.|
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