NEW YORK, April 7, 2015 /PRNewswire/ -- Delcath
Systems, Inc. (NASDAQ: DCTH) announces the expansion of its global
Phase 2 program for the treatment of patients with unresectable
hepatocellular carcinoma (HCC) or primary liver cancer. Montefiore
Medical Center in the Bronx, New
York has joined the U.S. Phase 2 HCC study and is now open
for patient enrollment. The Company now has two centers
participating in the U.S. Phase 2 HCC study, with another three
centers in Germany enrolling
patients in the EU Phase 2 HCC study. The Company expects to
include up to seven centers in Europe and the
United States in its global Phase 2 HCC program, and will
seek to enroll approximately 30 patients in total.
HCC is the most common primary cancer of the liver, with
approximately 700,000 new cases diagnosed worldwide annually.
Surgical removal is not possible for an estimated 80-90 percent of
primary liver cancer patients. In the U.S., the Phase 2 study will
investigate the safety and efficacy of Melphalan/HDS treatment
followed by sorafenib in patients with unresectable liver cancer
confined to the liver, evaluate tumor response (objective response
rate), as measured by modified Response Evaluation Criteria in
Solid Tumor (mRECIST), assess progression-free survival, safety,
and the safety of sorafenib following treatment with Melphalan/HDS.
Additional analyses will be conducted to characterize the systemic
exposure of melphalan administered by Melphalan/HDS, as well as an
assessment of patient-reported clinical outcomes, or
quality-of-life.
"We are pleased to have Montefiore Medical Center, a nationally
recognized Center of Excellence for cancer care and clinical
research, as a part of our global Phase 2 HCC program," said
Jennifer Simpson, Ph.D., Delcath's
Interim President and CEO. "We now have five centers open for
patient enrollment in the program, and with our prospective
commercial registry in Europe also
now open for enrollment, we are continuing to execute on all
elements of our Clinical Development Program."
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: timely patient
enrollment the ability to complete an interim evaluation of the
Company's Global Phase 2 HCC program, 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.
Contact Information:
Investor
Contact:
LHA
Anne Marie Fields,
afields@lhai.com
212-838-3777
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SOURCE Delcath Systems, Inc.