NEW YORK, Feb. 11, 2016 /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 engagement of Lars E. Birgerson, M.D., Ph.D., as the Company's Global Medical Consultant. Dr. Birgerson will provide strategic medical advisory and operational assistance to the Company's clinical operations team to help ensure timely facilitation of new clinical trial sites and the achievement of patient enrollment targets to meet interim analysis goals. Dr. Birgerson will also provide clinical development guidance for programs beyond ocular melanoma.
Dr. Birgerson brings significant experience and expertise to the task. Prior to joining Delcath, Dr. Birgerson was Senior Vice President, Medical Affairs for Bristol-Myers Squibb (BMS). In this role he led realignment of the Medical Affairs and Health Economics/Outcomes teams toward emerging opportunities in specialty medicine and immuno-oncology. Dr. Birgerson led the team that contributed to the successful launch of Yervoy® (ipilimumab) and Opdivo® (nivolumab), among others. Dr. Birgerson was also a member of the BMS Commercial Leadership Team and served on the Research & Development Executive Committee, the Portfolio Steering Committee, and served as Co-Chair of the Medical Review Group. Earlier in his career, Dr. Birgerson held senior leadership positions at Pharmacia Corporation, Roche Laboratories, and Genentech. Dr. Birgerson earned his M.D. and Ph.D. from Uppsala University in Sweden. He is a dual citizen of the United States and Sweden.
"Throughout my career I have worked to identify, nurture and develop emerging medical treatments that have the potential to contribute unique benefits to cancer patients," said Dr. Birgerson. "I see such an opportunity with the Melphalan/HDS. Delcath's clinical development program is robust and its recently announced FOCUS Phase 3 Trial in hepatic dominant ocular melanoma is compelling and well designed. The Company's commercial experience in Europe also points to a promising role for this technology in the treatment of a broad range of liver cancers beyond ocular melanoma. I am pleased to be working with the Delcath team at this exciting time."
"Dr. Birgerson's deep domain expertise in immuno-oncology and in global clinical development will be valuable assets to the timely execution of our clinical development program," said Jennifer K. Simpson, Ph.D., MSN, CRNP, President and CEO of Delcath Systems. "We welcome Lars to our team and look forward to his guidance."
About Delcath Systems
Delcath Systems, Inc. is a specialty pharmaceutical and medical device company focused on oncology with a principal focus 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). Melphalan/HDS has not been approved for sale in the U.S. We have commenced our global Phase 3 FOCUS Clinical Trial for Patients with Hepatic Dominant Ocular Melanoma (OM) and 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 intrahepatic cholangiocarcinoma (ICC).
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: the impact, if any, of publication of the Phase 3 trial manuscript 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 FOCUS Trial, Phase 2 HCC and ICC clinical trial, 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 major medical conferences 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 ZE reimbursement 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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