NEW YORK, April 21, 2015 /PRNewswire/ -- Delcath Systems,
Inc. (NASDAQ: DCTH) announces approval of amendments to its
Clinical Trial Authorizations (CTAs) filed with the U.K.'s
Medicines and Healthcare Products Regulatory Agency (MHRA) and
Germany's Federal Institute for
Drugs and Medical Devices (BfArM) for the expansion of the
Company's global Phase 2 program for the treatment of patients with
unresectable hepatocellular carcinoma (primary liver cancer, or
HCC), to include a cohort of patients with intrahepatic
cholangiocarcinoma (ICC).
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. The study will be
conducted at the same hospitals in Europe participating in the Company's Phase 2
HCC trial, and is expected to enroll 11 patients. The ICC 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, and look forward to enrolling patients in this cohort
beginning this quarter," said Jennifer
Simpson, Ph.D., Interim President and CEO of Delcath
Systems. "A positive efficacy signal may provide a regulatory
path 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/delcath-receives-approval-to-expand-global-phase-2-hcc-program-to-include-patients-with-intrahepatic-cholangiocarcinoma-300068875.html
SOURCE Delcath Systems, Inc.