NEW YORK, May 21, 2015 /PRNewswire/ -- Delcath Systems,
Inc. (NASDAQ: DCTH) announces that the intrahepatic
cholangiocarcinoma (ICC) study cohort of its expanded Global Phase
2 Clinical Trial Program of Melphalan/HDS for use in the treatment
of patients with unresectable hepatocellular carcinoma
(primary liver cancer, or HCC) has opened for patient enrollment.
The ICC study will be conducted at the same hospitals in
Europe participating in the
Company's Phase 2 HCC trial, and ICC enrollment is now open at
Goethe University Hospital in
Frankfurt, the Medical School
Hannover and Jena University Hospital. Additional centers in
Germany as well as centers in the
United Kingdom are expected to
open for enrollment in the coming weeks.
ICC is a tumor in the bile duct that arises within the
liver. It is the second most common primary liver tumor and
represents approximately 15% of new HCC cases diagnosed annually.
Surgical resection, the standard of care, is not possible for an
estimated 80% to 90% of patients diagnosed with ICC.
The ICC cohort of the Phase 2 trial will investigate the safety
and efficacy of Melphalan/HDS treatment in patients with
unresectable ICC confined to the liver. This cohort will
evaluate tumor response (objective response rate) as measured by
modified Response Evaluation Criteria in Solid Tumor (mRECIST), and
will assess progression-free survival and safety. Additional
analyses will be conducted to characterize the systemic exposure of
melphalan administered by Melphalan/HDS, as well as to assess
patient-reported clinical outcomes, or quality-of-life.
"We believe our Melphalan/HDS treatment may offer significant
clinical benefit for ICC patients who face limited treatment
options," said Jennifer Simpson,
Ph.D., Interim President and CEO of Delcath Systems. "A
positive efficacy signal may provide a regulatory pathway to a U.S.
registration trial, and consolidated safety data from the HCC and
ICC cohorts of this global Phase 2 trial will offer valuable
information for us to provide to the FDA."
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. Melphalan/HDS 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 a global
Phase 2 clinical trial in Europe
and the U.S. to investigate Melphalan/HDS for the treatment of
primary liver cancer (hepatocellular carcinoma or HCC), and we are
initiating a cohort within the global phase 2 clinical trial to
evaluate patients with intrahepatic cholangiocarcinoma (ICC).
We are also advancing plans to conduct a global Phase 3 trial in
ocular melanoma that has metastasized to the liver.
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 HCC, ICC and OM clinical trial programs timely
enrollment and treatment of patients in the global Phase 2 HCC and
ICC clinical trial, FDA and European Health Authority 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, acceptance of
the Phase 3 manuscript at a leading peer reviewed medical journal
and the impact of publication to support the Company's business,
the impact of the presentations at ESSO and SSO 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:
Anne Marie Fields
LHA
212-838-3777
afields@lhai.com
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/icc-cohort-of-delcaths-global-phase-2-trial-of-melphalanhds-in-hepatocellular-carcinoma-now-open-for-enrollment-300086813.html
SOURCE Delcath Systems, Inc.