NEW
YORK, Jan. 16, 2024 /PRNewswire/ -- Delcath
Systems, Inc. (Nasdaq: DCTH), an interventional oncology
company focused on the treatment of primary and metastatic cancers
of the liver, today announced the first commercial use of HEPZATO
KIT for the treatment of metastatic uveal melanoma (mUM).
The procedure took place at Moffitt Cancer Center in
Tampa, Florida by Dr. Jonathan S. Zager, M.D., Chief Academic Officer;
Senior Member, Department of Cutaneous, Oncology; Director of
Regional Therapies, Moffitt Cancer Center. Dr. Zager was the
global Lead Investigator for the FOCUS Phase 3 trial.
"The fact that patients with difficult to treat metastatic uveal
melanoma with limited treatment options now have another
alternative is truly remarkable and exciting. There has been a
large unmet need for liver directed therapy options to treat this
patient population and we intend to incorporate this as standard of
care for appropriate patients," said Dr. Zager. Dr. Zager enrolled
and treated the first and last patients on the FOCUS Phase 3 trial
and the team at Moffitt has performed the procedure over 200 times
to date.
The company is working with numerous other leading cancer
centers across the U.S. which have indicated interest in HEPZATO
KIT to ensure patients nationwide have access to this important
treatment. In conjunction with the first commercial treatment,
Delcath also launched websites relating to the HEPZATO KIT,
including HEPZATO KIT, HEPZATO KIT REMS, and HEPZATO KIT Access, to
support the commercial launch.
"The first commercial procedure utilizing HEPZATO KIT in the
U.S. is a significant milestone for Delcath and patients suffering
from metastatic uveal melanoma. We are proud to continue our
relationship with Dr. Zager and the team at Moffitt Cancer Center
to bring this unique treatment to appropriate patients in need. I
want to thank all the collaborators and patients who participated
in the long but necessary process to bring HEPZATO KIT to market,"
said Gerard Michel, Delcath's Chief
Executive Officer.
About HEPZATO KIT
HEPZATO KIT (melphalan for Injection/Hepatic Delivery System),
approved for use in the United States by FDA, is a
combination drug/device product which administers HEPZATO
(melphalan) directly to the liver through the HDS, which permits
higher drug exposure in target tissues while limiting systemic
toxicity.
HEPZATO KIT is approved in the United States as a
liver-directed treatment for adult patients with uveal melanoma
with unresectable hepatic metastases affecting less than 50% of the
liver and no extrahepatic disease, or extrahepatic disease limited
to the bone, lymph nodes, subcutaneous tissues, or lung that is
amenable to resection or radiation.
HEPZATO KIT Important Safety Information
Patients eligible for HEPZATO KIT should NOT have any of the
following medical conditions:
- Active intracranial metastases or brain lesions with a
propensity to bleed
- Liver failure, portal hypertension, or known varices at risk
for bleeding
- Surgery or medical treatment of the liver in the previous 4
weeks
- Active cardiac conditions including unstable or severe angina
or myocardial infarction), worsening or new-onset congestive heart
failure, significant arrhythmias, or severe valvular disease
- History of allergies or known hypersensitivity to melphalan or
a component or material utilized within the HEPZATO KIT including
natural rubber latex, heparin, and severe hypersensitivity to
iodinated contrast not controlled by antihistamines and
steroids
Most common adverse reactions or laboratory abnormalities
occurring with HEPZATO KIT treatment are thrombocytopenia,
fatigue, anemia, nausea, musculoskeletal pain, leukopenia,
abdominal pain, neutropenia, vomiting, increased alanine
aminotransferase, prolonged activated partial thromboplastin time,
increased alkaline phosphatase, increased aspartate
aminotransferase and dyspnea.
Severe peri-procedural complications including hemorrhage,
hepatocellular injury, and thromboembolic events may occur via
hepatic intra-arterial administration of HEPZATO. HEPZATO KIT is
available only through a restricted program under a Risk Evaluation
and Mitigation Strategy called the HEPZATO KIT REMS.
Myelosuppression with resulting severe infection, bleeding, or
symptomatic anemia may occur with HEPZATO. Additional cycles of
HEPZATO KIT therapy will be delayed until blood counts have
improved.
Please see the full Prescribing Information, including BOXED
WARNING for the HEPZATO KIT.
About Delcath Systems, Inc.
Delcath Systems, Inc. is an interventional oncology company
focused on the treatment of primary and metastatic liver cancers.
The Company's proprietary products, HEPZATO KIT (melphalan for
Injection/Hepatic Delivery System), approved for use in the
United States by FDA, and CHEMOSAT Hepatic Delivery System for
Melphalan percutaneous hepatic perfusion, designated under the
medical device regulation for use in Europe and
the United Kingdom, are designed to administer high-dose
chemotherapy to the liver while controlling systemic exposure and
associated side effects during a PHP procedure.
Forward Looking Statements
The Private Securities
Litigation Reform Act of 1995 provides a safe harbor for
forward-looking statements made by the Company or on its behalf.
This press release contains forward-looking statements, which are
subject to certain risks and uncertainties, that can cause actual
results to differ materially from those described. The words
"anticipate," "believe," "continue," "could," "estimate," "expect,"
"intend," "may," "plan," "potential," "predict," "project,"
"should," "target," "will," "would" and similar expressions are
intended to identify forward-looking statements, although not all
forward-looking statements contain these identifying words. Factors
that may cause such differences include, but are not limited to,
uncertainties relating to: the Company's commercialization plans
and its ability to successfully commercialize the HEPZATO KIT; the
Company's successful management of the HEPZATO KIT supply chain,
including securing adequate supply of critical components necessary
to manufacture and assemble the HEPZATO KIT; successful FDA
inspections of the facilities of the Company and those of its
third-party suppliers/manufacturers; the Company's successful
implementation and management of the HEPZATO KIT Risk Evaluation
and Mitigation Strategy; the potential benefits of the
HEPZATO KIT as a treatment for patients with primary and metastatic
disease in the liver; the Company's ability to obtain reimbursement
for the HEPZATO KIT; and the Company's ability to successfully
enter into any necessary purchase and sale agreements with users of
the HEPZATO KIT. For additional information about these
factors, and others that may impact the Company, please see the
Company's filings with the Securities and Exchange Commission,
including those on Forms 10-K, 10-Q, and 8-K. However, new risk
factors and uncertainties may emerge from time to time, and it is
not possible to predict all risk factors and uncertainties.
Accordingly, 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:
Investor Relations Contact:
Ben Shamsian
Lytham Partners
646-829-9701
shamsian@lythampartners.com
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SOURCE Delcath Systems, Inc.