Delcath Announces Updated Efficacy Results From Phase 3 Trial of Chemosaturation for Melanoma Metastases in the Liver Presented at European Multidisciplinary Cancer Congress

New York and Stockholm (ots/PRNewswire) -

March 2011 Data Confirm Strong Treatment Effect of
Chemosaturation

Delcath Systems announced today that James F. Pingpank, MD,
FACS, Associate Professor of Surgery at the University of Pittsburgh
School of Medicine, will present updated investigator results from
the Phase 3 randomized trial of Delcath's chemosaturation system with
melphalan in patients with hepatic metastases from ocular or
cutaneous melanoma.

Dr. Pingpank, a lead principal investigator of the Phase 3 trial,
will present the abstract (9304), "Percutaneous Hepatic Perfusion
(PHP) vs. Best Alternative Care (BAC) for Patients with Melanoma
Liver Metastases - Efficacy Update of the Phase 3 Trial," in the
plenary session today at 11:15am CEST at the European
Multidisciplinary Cancer Congress in Stockholm. These updated results
include follow-up data from patients through March 2011, an
additional 12 months of data maturation from when Dr. Pingpank first
presented investigator data from this Phase 3 trial in June 2010, at
the American Society of Clinical Oncology's Annual Meeting.

With respect to the study's primary endpoint of hepatic
progression free survival ("hPFS"), the updated investigator-assessed
results showed that patients in the chemosaturation arm demonstrated
median hPFS of 8.0 months compared to 1.6 months in the BAC arm, a
significant 6.4 month extension of hPFS (hazard ratio 0.35,
p<0.0001). Median overall PFS in the chemosaturation arm was 6.7
months compared to 1.6 months in the BAC arm, an increase of 5.1
months (hazard ratio 0.36, p<0.0001).

As reported previously, the hepatic response rate in the
chemosaturation arm was 34% compared to 2% for the BAC arm. In
addition, 52% of patients in the chemosaturation arm achieved stable
disease, compared with 27% in the BAC group, giving a tumor growth
control rate of 86% for the chemosaturation group versus 29% for the
BAC group (p<0.001). Patients who crossed from the BAC arm to
chemosaturation treatment after progression of liver disease showed
consistent efficacy with patients treated on the chemosaturation arm.
As expected, there was no difference in overall survival in the
randomized study due to the crossover trial design. An analysis of
survival trends by patient cohorts indicated that patients treated
with chemosaturation, including crossover patients, had a median
survival of 11.4 months compared to 4.1 months for BAC patients who
did not receive chemosaturation. As of June 30th, 11 patients treated
with chemosaturation were still alive compared to two patients in the
BAC arm who did not receive chemosaturation.

"The additional 12 months of data and extended survival for a
significant percentage of the treated patients confirm our belief
that chemosaturation may provide a significantly better option than
the few treatments presently available for patients with melanoma
metastases in the liver," said Eamonn P. Hobbs, President and CEO of
Delcath. "The hepatic PFS, overall PFS and response rate are
consistent with past investigator assessments and highly
statistically significant. We are encouraged by the data presented in
Stockholm today."

About Delcath Systems

Delcath Systems, Inc. is a development stage specialty
pharmaceutical and medical device company focused on oncology.
Delcath's proprietary system for chemosaturation is designed to
administer high dose chemotherapy and other therapeutic agents to
diseased organs or regions of the body, while controlling the
systemic exposure of those agents. The Company's initial focus is on
the treatment of primary and metastatic liver cancers. In 2010,
Delcath concluded a Phase 3 metastatic melanoma study, and the
Company recently completed a multi-arm Phase 2 trial to treat other
liver cancers. The Company obtained authorization to affix a CE Mark
for the Hepatic CHEMOSAT delivery system in April 2011. The Company
has not yet received FDA approval for commercial sale of its system
in the United States. For more information, please visit the
Company's website at http://www.delcath.com.

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 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 time required to build inventory and
establish commercial operations in Europe, adoption, use and
resulting sales, if any, for the Hepatic CHEMOSAT delivery system in
the EEA, our ability to successfully commercialize the
chemosaturation system and the potential of the chemosaturation
system as a treatment for patients with terminal metastatic disease
in the liver including metastatic melanoma to the liver,
acceptability of the Phase III clinical trial data by the FDA, our
ability to address the issues raised in the Refusal to File letter
received from the FDA and the timing of our re-submission of our NDA,
re-submission and acceptance of the Company's NDA by the FDA,
approval of the Company's NDA for the treatment of metastatic
melanoma to the liver, adoption, use and resulting sales, if any, in
the United States, approval of the current or future chemosaturation
system for other indications, actions by the FDA or other foreign
regulatory agencies, our ability to obtain reimbursement for the
CHEMOSAT system, our ability to successfully enter into distribution
and strategic partnership agreements in foreign markets and the
corresponding revenue associated with such foreign markets,
uncertainties relating to the results of research and development
projects and future clinical trials, and uncertainties regarding our
ability to obtain financial and other resources for any research,
development 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.

ots Originaltext: Delcath Systems
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Contact Information: Investor Contact: Doug Sherk/Gregory Gin,
EVC Group, +1-415-568-4887/+1-646-445-4801; Media Contact: Janine
McCargo,
EVC Group, +1-646-688-0425