On October 2, 2014 Delcath Systems reported the opening of its United States (U.S.) Clinical Development Program for first-line treatment of patients with unresectable hepatocellular carcinoma (HCC) or primary liver cancer (Press release Delcath Systems, OCT 2, 2014, View Source;p=RssLanding&cat=news&id=1973316 [SID:1234500779]). Moffitt Cancer Center in Tampa, Florida is the first U.S. center to open for patient enrollment. Johann Wolfgang Goethe University Hospital (JWG) in Frankfurt, Germany opened for enrollment in the European HCC Phase 2 trial in July. The Company’s Clinical Development Program is expected to include four to seven centers in Europe and United States and will seek to enroll approximately 30 patients.
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HCC is the most common primary cancer of the liver, with approximately 700,000 new cases diagnosed worldwide annually. Surgical removal is not possible for an estimated 80-90 percent of primary liver cancer patients. In the U.S., the Phase 2 program will investigate the safety and efficacy of Melphalan/HDS treatment followed by sorafenib in patients with unresectable liver cancer confined to the liver, evaluate tumor response (objective response rate), as measured by modified Response Evaluation Criteria in Solid Tumor (mRECIST), assess progression-free survival, safety, and the safety of sorafenib following treatment with Melphalan HDS. Additional analyses will be conducted to characterize the systemic exposure of melphalan administered by Melphalan HDS, as well as an assessment of patient-reported clinical outcomes, or quality-of-life.
"Moffitt Cancer Center is an early pioneer in the clinical trial use of the Melphalan/HDS to treat patients with liver cancers. We are pleased that Moffitt will play a leading role in our HCC Phase 2 program," said Dr. Jennifer Simpson, Delcath’s Interim President and CEO. "We now have two centers one in each of the U.S. and Europe participating in our HCC Phase 2 program, and we expect to add additional sites in both regions in the coming months. Subject to timely enrollment of eligible patients, we anticipate having interim data from this trial available in the first half of 2015."