The pivotal, Phase III study is being led by the National Cancer Institute, which previously approved the study’s expansion to a multi-center trial. University of Maryland Medical Center (UMMC) has also entered into a clinical research agreement with Delcath enabling the hospital to immediately begin recruiting and treating patients.
Richard Alexander, professor of surgery and associate chairman for clinical research, surgery at the University of Maryland will serve as principal investigator of the study at this new center.
Richard Taney, president and CEO of Delcath Systems, said: “Throughout 2008, we expect to expand the study to additional clinical sites with world-class clinical oncology programs. Several of these sites are currently in the process of securing the necessary approvals in order to join our clinical trials.”