NEW YORK, Feb. 4, 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 that Company
management will participate at two upcoming investor conferences in
February.
- 18th Annual BIO CEO & Investor Conference
taking place on February 8-9, 2016 in
New York City. Jennifer K. Simpson, Ph.D., President, and Chief
Executive Officer of Delcath, will present a corporate overview at
2:30 p.m. Eastern time on
February 8th.
- Source Capital Group's 2016 Disruptive Growth &
Healthcare Conference taking place February 10-11, 2016 in New York City. Dr. Simpson will deliver the
corporate presentation at 1:45 p.m. Eastern
time on February
11th.
Dr. Simpson's presentation at BIO CEO will be webcast live and
will be archived and available on the Company's website at
www.delcath.com.
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 the treatment of 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 timing and results
of the Company's clinical trials including without limitation
the OM, HCC ,and ICC clinical trial programs, timely
enrollment and treatment of patients in the global Phase 3 FOCUS
Clinical Trial for Patients with Hepatic Dominant Ocular Melanoma
and the global Phase 2 HCC and ICC clinical trials, 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,
if any, of publication of the Phase 3 trial manuscript to support
the Company's efforts, 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 remaining
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.