Enrollment in Delcath's Pivotal Phase III Metastatic Melanoma Clinical Trial Reaches Halfway Point
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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
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.
About Delcath Systems, Inc.
Delcath Systems, Inc. is a medical technology company specializing in cancer treatment. The Company is testing a proprietary, patented drug delivery system for the treatment of liver cancers. Delcath's novel drug delivery platform is testing the delivery of ultra-high doses of anti-cancer drugs to the liver while preventing these high doses of drug from entering the patient's bloodstream. The Company is currently enrolling patients in Phase III and Phase II clinical studies for the treatment of liver cancers using high doses of melphalan. The Company's intellectual property portfolio 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.
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