Retrospective Analysis of Changes in Patients
with Metastatic Uveal Melanoma treated with Chemosat Hepatic
Delivery System
Results Support that Utilizing Delcath's HDS
to Administer High-Dose Melphalan to the Liver Is Well Tolerated by
Patients
NEW
YORK, Dec. 7, 2023 /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 publication of a clinical study in the
journal Melanoma Research. The publication, entitled "Quality of
Life After Melphalan Hepatic Perfusion for Uveal Melanoma", was
based on an independent clinical study conducted by investigators
from University Hospital Southampton,
UK and focused on the impact of melphalan percutaneous
hepatic perfusion treatment on the quality of life (QoL) of
patients with metastatic uveal melanoma. Melphalan Hepatic
Perfusion, also known as Percutaneous Hepatic Perfusion (PHP),
utilizes CHEMOSAT, Delcath's proprietary European CE Marked Hepatic
Delivery System (HDS), to administer high-dose melphalan to the
liver, while controlling systemic exposure and associated side
effects.
Uveal melanoma usually shows a liver-dominant metastatic spread
and is often treated with liver directed therapies. While the
safety and efficacy profile of utilizing Delcath's HDS to
administer high-dose melphalan to the liver is favorable and well
established based on results from several clinical studies, the
impact of this treatment on QoL has not been widely investigated.
When assessing the value of a treatment, clinicians often weigh its
efficacy and effect on overall survival against any negative impact
of the treatment on QoL.
Investigators used the FACT-G (Functional Assessment of Cancer
Therapy – General) questionnaire which has been specifically
developed for and validated in oncology patients. The FACT-G
questionnaire consists of 4 subdomains: physical (PWB), social
(SWB), emotional (EWB) and functional (FWB) wellbeing.
The study included 20 patients with metastatic uveal melanoma
treated at the University Hospital Southampton between August 2020 and January
2023. The FACT-G questionnaire was administered
pre-treatment and post-treatment on day 1, day of discharge, day 7,
14 and 28. Immediately following treatment, PWB and FWB decreased
relative to baseline; by day 14 no residual significant difference
was observed and on day 28 overall scores were almost at baseline.
Interestingly, an improvement over baseline in EWB was observed by
day 28.
The authors conclude their results support the growing body of
evidence that utilizing Delcath's HDS to administer high-dose
melphalan to the liver is well tolerated by patients does not
negatively effect their quality of life. A link to the
publication's abstract can be found here.
"The publication of these results by independent investigators
supports the rationale for the percutaneous hepatic perfusion
procedure, whether utilizing melphalan delivered by Delcath's CE
marked Chemosat or the FDA approved HEPZATO KIT, as an important
treatment option for patients with liver-dominant uveal melanoma,"
said Dr. Vojo Vukovic, Delcath's
Chief Medical Officer. "We look forward to making this treatment
option available to patients in the US in January 2024."
About Chemosat and HEPZATO KIT
CHEMOSAT Hepatic
Delivery System for Melphalan percutaneous hepatic perfusion (PHP)
is designated a class lll medical device under the Medical Device
Regulation for use in Europe and
the United Kingdom. The Hepatic
Delivery System (HDS) is designed to administer high-dose
chemotherapy to the liver while controlling systemic exposure and
associated side effects during a PHP procedure. The use of the HDS
allows a healthcare provider team to surgically isolate the liver
while the hepatic venous blood is filtered during melphalan
infusion and subsequent washout during a Percutaneous Hepatic
Perfusion (PHP) procedure. PHP, which can only be performed with
Delcath's HDS, results in loco-regional delivery of a relatively
high melphalan dose. For more information regarding CHEMOSAT and
its use, please visit Chemosat.com.
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
metastatic uveal melanoma (mUM) 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.
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 (PHP), 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.