DELCATH ADDS NEW CENTERS TO GLOBAL PHASE 2 HCC PROGRAM
December 11 2014 - 7:01AM
Hannover Medical
School Hospital and Jena University Hospital in Germany
Open for Enrollment
New York, NY -
December 11, 2014 - Delcath Systems, Inc. (NASDAQ: DCTH) today
announced that two research hospitals in Germany have joined the
Company's Global Phase 2 Clinical Program for first-line treatment
of patients with unresectable hepatocellular carcinoma (HCC), or
primary liver cancer. The staffs at Hannover Medical School
Hospital and Jena University Hospital have completed their initial
training in the use of the Melphalan Hepatic Delivery System
(Melphalan/HDS), and the centers are now open for patient
enrollment in the Global Phase 2 HCC Program. The two centers join
Goethe University Hospital Frankfurt and Moffitt Cancer Center in
Tampa, Florida as participants in the Global Phase 2 HCC
Program.
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
Europe, the Company's Phase 2 trial program will investigate the
safety and efficacy of Melphalan/HDS treatment without 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), and
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 assess
patient-reported clinical outcomes, or quality-of-life. The
Company's Global Phase 2 HCC Program is expected to include four to
seven centers in Europe and the United States, and seeks to enroll
approximately 30 patients.
About Delcath
Systems
Delcath Systems, Inc. is a
specialty pharmaceutical and medical device company focused on
oncology. Our proprietary product-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 the systemic exposure to those agents.
The Company's principal focus is on the treatment of primary
and metastatic liver cancers. In the United States, the
Melphalan/HDS system is considered a combination drug and device
product, and is regulated as a drug by the United States Food and
Drug Administration (FDA). The Melphalan/HDS system has not
been approved for sale in the United States. In Europe, our
proprietary system to deliver and filter melphalan hydrochloride is
marketed as a device under the trade name Delcath Hepatic CHEMOSAT®
Delivery System for Melphalan (CHEMOSAT). In April 2012, we
obtained authorization to affix a CE Mark for the Generation Two
CHEMOSAT system. The right to affix the CE mark
allows the Company to market and sell the CHEMOSAT system in
Europe. The Company has commenced a Global Phase 2 clinical trial
in Europe and the United States to investigate Melphalan/HDS system
for primary liver cancer and is initiating plans to evaluate
intrahepatic cholangiocarcinoma.
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
enrollment and treatment of patients in the Phase 2 HCC trial,
IRB or ethics committee clearance of the Phase 2 HCC protocol
from additional participating sites and the timing of site
activation and subject enrollment in the HCC Phase 2 trial
program, the timing and results of clinical trials
including without limitation the HCC clinical trial program, the
ability of hospitals in Germany to successfully negotiate and
receive reimbursement for the CHEMOSAT procedure in their region
under Value 4 status and the amount of reimbursement, if any, to be
provided under Value 4 status in 2014, approval of Individual
Funding Requests for reimbursement of the CHEMOSAT procedure, the
impact 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
CHEMOSAT/Melphalan/HDS system and the potential of the
CHEMOSAT/Melphalan/HDS 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 CHEMOSAT/Melphalan/HDS system for delivery
and filtration of melphalan or other chemotherapeutic agents for
various indications in the US 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: |
Media Contact: |
Michael Polyviou/Doug Sherk |
John Carter |
EVC Group |
EVC Group |
212-850-6020 |
212-850-6021 |
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information contained therein.
Source: Delcath Systems, Inc via Globenewswire
HUG#1879031