NEW YORK, March 27, 2015 /PRNewswire/ -- Delcath Systems, Inc. (NASDAQ: 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."
About Delcath Systems
Delcath Systems, Inc. is a specialty pharmaceutical and medical device company focused on oncology with an emphasis on the treatment of primary and metastatic liver cancers. Our proprietary Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System (Melphalan/HDS) is designed to administer high-dose chemotherapy to the liver while controlling systemic exposure. In April 2012 we obtained authorization to affix a CE Mark to our second-generation system, which is currently marketed in Europe as a device under the trade name Delcath Hepatic CHEMOSAT® Delivery System for Melphalan (CHEMOSAT). In the U.S. the Melphalan/HDS system is considered a combination drug and device product, and is regulated as a drug by the U.S. Food and Drug Administration (FDA). The Melphalan/HDS system has not been approved for sale in the U.S. We have commenced a global Phase 2 clinical trial in Europe and the U.S. to investigate the Melphalan/HDS system for the treatment of primary liver cancer (HCC), and expect to initiate a global Phase 3 trial in ocular melanoma (OM) that has metastasized to the liver and plan to evaluate intrahepatic cholangiocarcinoma (ICC) in a Phase 2 clinical study.
Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by the Company or on its behalf. This news release contains forward-looking statements, which are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to, uncertainties relating to: future patient outcomes and clinical trial results consistent with the data contained in the SSO abstract, acceptance and publication of the Phase 3 trial manuscript and the impact of publication to support the Company's efforts, the timing and results of the Company's clinical trials including without limitation the HCC, ICC and OM clinical trial programs timely enrollment and treatment of patients in the global Phase 2 HCC and ICC clinical trial, FDA approval of the global Phase 3 OM clinical trial protocol, IRB or ethics committee clearance of the Phase 2 HCC/ICC and/or Phase 3 OM protocols from participating sites and the timing of site activation and subject enrollment in each trial, the impact of the presentations at ESSO and future clinical results consistent with the data presented, approval of Individual Funding Requests for reimbursement of the CHEMOSAT procedure, the impact, if any of Value 4 status on potential CHEMOSAT product use and sales in Germany, clinical adoption, use and resulting sales, if any, for the CHEMOSAT system to deliver and filter melphalan in Europe including the key markets of Germany and the UK, the Company's ability to successfully commercialize the Melphalan HDS/CHEMOSAT system and the potential of the Melphalan HDS/CHEMOSAT system as a treatment for patients with primary and metastatic disease in the liver, our ability to obtain reimbursement for the CHEMOSAT system in various markets, the Company's ability to satisfy the requirements of the FDA's Complete Response Letter and provide the same in a timely manner, approval of the current or future Melphalan HDS/CHEMOSAT system for delivery and filtration of melphalan or other chemotherapeutic agents for various indications in the U.S. and/or in foreign markets, actions by the FDA or other foreign regulatory agencies, the Company's ability to successfully enter into strategic partnership and distribution arrangements in foreign markets and the timing and revenue, if any, of the same, uncertainties relating to the timing and results of research and development projects, our ability to maintain NASDAQ listing, and uncertainties regarding the Company's ability to obtain financial and other resources for any research, development, clinical trials and commercialization activities. These factors, and others, are discussed from time to time in our filings with the Securities and Exchange Commission. You should not place undue reliance on these forward-looking statements, which speak only as of the date they are made. We undertake no obligation to publicly update or revise these forward-looking statements to reflect events or circumstances after the date they are made.
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