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.
Contact Information:
Investor Contact:
Anne Marie Fields
LHA
212-838-3777
afields@lhai.com
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SOURCE Delcath Systems, Inc.