Delcath Systems has reported that the Data and Safety Monitoring Board (DSMB) has reviewed clinical data on 77 patients enrolled in its pivotal phase III clinical trial. DSMB has recommended that the trial should continue to enroll patients with the goal of reaching the 92 patients required to complete the study.
Reportedly, the clinical study is testing the Delcath 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 PHP System is designed to deliver significantly higher doses of anti-cancer drugs to a patient’s liver, while minimising entry of the drugs into the rest of the patient’s circulation.
The company said that DSMB is reviewing and evaluating the safety and response data generated from the company’s phase III trial.
The primary responsibilities of the DSMB are to ensure the safety of all patients enrolled in the trial, the quality of the data collected and the continued scientific validity of the trial design. In addition, the company expects enrollment to be completed by mid-October.
Eamonn Hobbs, president and CEO of Delcath Systems said: “We are pleased by the successful review of our safety data and the recent, accelerated pace of enrollment, which has put us in the trial’s home stretch. This is an exciting time for the company. With current enrollment trends, we now expect to complete enrollment by the middle of October and are still on track for an FDA submission by mid-2010.”