Delcath to Offer Data Highlighting Melphalan/HDS Trial at SSO Annual Meeting

Delcath Systems, Inc. DCTH, a specialty pharmaceutical and medical device company focused on oncology with an emphasis on the treatment of primary and metastatic liver cancers, announces the reporting of data from a single -center experience utilizing the Company's Melphalan Hydrochloride for Injection with the Delcath Hepatic Delivery System (Melphalan/HDS) and other locoregional therapies in a poster presentation at the Society of Surgical Oncology (SSO) Annual Meeting 2015. The data were presented by Andrea Abbott, M.D., Surgical Oncology, Moffitt Cancer Center in a poster titled "Hepatic Progression Free and Overall Survival after Regional Therapy to the Liver for Metastatic Melanoma" as part of the Melanoma and Sarcoma Session at the meeting. The poster can be accessed on the SSO website. Melphalan/HDS is an investigational product in the U.S. and was used in clinical settings at the Moffitt Cancer Center. In this retrospective study of 30 patients with cutaneous or uveal melanoma that metastasized to the liver, investigators evaluated outcomes on hepatic progression free survival (HPFS), progression free survival (PFS) and overall survival (OS) following treatment with yttrium-90 (Y90), chemoembolization (CE) or percutaneous hepatic perfusion (PHP). In the study six patients received Y90, 10 patients were treated with PHP, 12 patients were treated with CE, one patient received Y90 after PHP and one patient received PHP following treatment with CE. Kaplan-Meier survival estimates, log-rank tests and multivariate time-dependent Cox regression analyses (MVA) were used to relate patient, tumor and treatment variables to HPFS, PFS and OS. The study showed a significant difference in median HPFS with 54 days for patients treated with Y90, 80 days for patients treated with CE and 310 days for those treated with PHP (p=0.002). MVA showed improved HPFS for PHP versus Y90 (p=0.001) and for PHP versus CE (p=0.008), but not for CE versus Y90 (p=0.44). Median OS from time of treatment was longest for PHP at 736 days versus Y90 285 days and CE 265 days; however it did not reach statistical significance. There was a significant difference on MVA of OS for PHP versus Y90 (p = 0.03) but not for PHP versus CE (p=0.37) or CE versus Y90 (0.06). According to study author, Jonathan Zager, M.D., Surgical Oncology, Moffitt Cancer Center, the study concluded that, "HPFS and PFS were significantly prolonged in patients treated with PHP versus CE and Y90. Median OS in PHP patients was over double that seen in Y90 or CE patients but was significant on MVA only between PHP and Y90." "We are particularly pleased to have these data presented at the SSO 2015, as it enhances awareness of our Melphalan/HDS among an audience of the world's premier surgical oncologists," stated Jennifer Simpson, Ph.D., Interim President and Chief Executive Officer of Delcath Systems. "In Europe, where our Hepatic Delivery System is commercially available, we have also observed encouraging survival data from the experiences of practitioners using our CHEMOSAT® Delivery System for Melphalan. Availability of these data is very timely as we advance plans for our pivotal Phase 3 clinical trial in ocular melanoma that is metastatic to the liver with overall survival as the primary endpoint."