DELCATH COMMENCES U.S. PHASE 2 STUDY OF MELPHALAN HEPATIC DELIVERY SYSTEM IN PRIMARY LIVER CANCER
October 02 2014 - 7:00AM
Moffitt Cancer Center In Tampa, Florida Opens For
Enrollment
New York, NY
- October 2, 2014 - Delcath Systems, Inc. (NASDAQ: DCTH)
today announced the opening of its United States (U.S.) Clinical
Development Program for first-line treatment of patients with
unresectable hepatocellular carcinoma (HCC) or primary liver
cancer. Moffitt Cancer Center in Tampa, Florida is the first U.S.
center to open for patient enrollment. Johann Wolfgang Goethe
University Hospital (JWG) in Frankfurt, Germany opened for
enrollment in the European HCC Phase 2 trial in July. The Company's
Clinical Development Program is expected to include four to seven
centers in Europe and United States and will seek to enroll
approximately 30 patients.
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 program 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.
"Moffitt Cancer Center is an early
pioneer in the clinical trial use of the Melphalan/HDS to treat
patients with liver cancers. We are pleased that Moffitt will play
a leading role in our HCC Phase 2 program," said Dr. Jennifer
Simpson, Delcath's Interim President and CEO. "We now have two
centers one in each of the U.S. and Europe participating in our HCC
Phase 2 program, and we expect to add additional sites in both
regions in the coming months. Subject to timely
enrollment of eligible patients, we anticipate having interim data
from this trial available in the first half of 2015."
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 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: the
ability of Moffitt and JWG to timely enroll and treat patients in
the Phase 2 HCC trial, IRB or ethics committee clearance of
the Phase II HCC protocol from additional participating sites and
the timing of site activation and subject enrollment in the HCC
Phase II 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
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 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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Source: Delcath Systems, Inc via Globenewswire
HUG#1860201