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UMMC has also entered into a clinical research agreement with Delcathenabling the hospital to immediately begin recruiting and treating patients.H. Richard Alexander, M.D., Professor of Surgery and Associate Chairman forClinical Research, Surgery at the University of Maryland will serve asPrincipal Investigator of the study at this new center. Dr. Alexander, arecognized leader in the field of regional cancer therapy, was previouslyDeputy Director of the NCI's Center for Cancer Research, and PrincipalInvestigator of the Phase I study that was Fast Tracked to this current PhaseIII study.
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"The diagnosis of liver metastases results in a very poor prognosis forthe patient," commented Dr. Alexander. "The Delcath System may represent aneffective, minimally toxic means of restoring liver health and improvingpatient outcome. UMMC is committed to remaining at the forefront of cancerresearch and treatment. We look forward to participating in this NCI-ledpivotal study and to understanding how this system may benefit patients."
"Expanding this Phase III study to premier oncology centers such as UMMCremains a top priority for the Company, as it allows the Delcath System toreach more patients desperately in need of new treatment options and expandsphysician awareness of its potential clinical benefit," said Richard L. Taney,President and CEO of Delcath Systems. "It is especially exciting to becollaborating with Dr. Alexander, who pioneered the use of our PHP system withMelphalan while at the NCI. Throughout 2008, we expect to expand the study toadditional clinical sites with world-class clinical oncology programs.Several of these sites are currently in the process of securing the necessaryapprovals in order to join our clinical trials."
The Phase III Study
The Phase III study is designed to test Delcath's proprietary PHP Systemfor the regional delivery of melphalan to the liver to treat patients withmetastatic ocular and cutaneous melanoma who have unresectable tumors in theliver. The Delcath System is designed to deliver significantly higher doses ofanti-cancer drugs to a patient's liver while preventing entry of the drugs tothe rest of the patient's circulation. This isolation limits toxicities thatresult from systemic chemotherapy treatments.
Patients in the Phase III trial initially are randomized into one of twotreatment arms, including immediate treatment with melphalan via the DelcathSystem or treatment with best alternative care. The study is designed toevaluate the duration of tumor response in each of the two study arms.Following guidelines established by U.S. Food and Drug Administration (FDA)under a Special Protocol Assessment (SPA), when disease progresses in patientsenrolled in the best alternative care arm of the trial, they are permitted to"cross over" and receive treatment with the Delcath System.
About University of Maryland Medical Center
The University of Maryland Medical Center (UMMC) is the heart of theUniversity of Maryland Medical System's downtown campus. The hospitalprovides comprehensive care for the West Baltimore community and tertiary carefor Maryland and the surrounding area. In partnership with the University ofMaryland School of Medicine, UMMC's vision is to be internationally recognizedfor world-class clinical programs distingu
