Positive Phase 2 Trial Results from Neuroendocrine Tumor Cohort Presented at CIRSE

New York and Munich (ots/PRNewswire) -

Chemosaturation Demonstrates Clinically Meaningful Tumor

Response with Unresectable Neuroendocrine Tumors in the Liver

Delcath Systems, Inc. announced that updated results from the
metastatic neuroendocrine tumor (mNET) cohort of the Company's
recently completed Phase 2 clinical trial were presented at the
Cardiovascular and Interventional Radiological Society of Europe
(CIRSE) congress held this week in Munich, Germany. James F.
Pingpank, MD, FACS, Associate Professor of Surgery at the University
of Pittsburgh School of Medicine and a Principal Investigator of the
Phase 2 trial, presented the late-breaking abstract on September 12,
2011at 4:45pm during an Oncologic Intervention oral abstract session.

In the Phase 2 trial's mNET cohort, 24 patients with unresectable
mNET in the liver underwent an average of 3 chemosaturation
procedures with concentrated melphalan and subsequent extra-corporeal
venous hemofiltration. The primary endpoint of overall hepatic
response rate (ORR) among the 20 evaluable patients was 70%,
including one patient who presented with a confirmed complete
response (CR) and 13 with confirmed partial responses (PR). Four
patients had stable disease (SD) and 2 progressed at their first
evaluation, giving a tumor growth control rate of 90%. As for
secondary endpoints, the median overall survival in all 24 patients
(on an intent to treat or ITT basis) was reported as 30.4. months.
The safety profile of the chemosaturation system was consistent with
that previously reported for the Company's Phase 3 melanoma trial.

"Currently available treatment options for patients with
unresectable neuroendocrine liver metastases have response rates
around 5%. The anti-tumor activity and duration of response seen in
the mNET arm of this Phase 2 study is very positive, and suggest a
potential role for chemosaturation in this difficult to treat
population" said Eamonn P. Hobbs, President & CEO of Delcath. "More
importantly, we believe these results provide a strong signal of
efficacy in liver metastases other than melanoma, and support our
belief that chemosaturation will eventually play a broad role in
disease control in the liver."

The Phase 2 study was conducted at the National Cancer Institute
(NCI) in the U.S., and included four cohorts enrolling patients with
hepatobiliary cancers, as well as metastatic cancers of
neuroendocrine, ocular or cutaneous melanoma, and colorectal
(adenocarcinoma) origins. The primary objectives were to determine
the response rate and duration of response to intrahepatic infusion
of melphalan with subsequent venous hemofiltration. Secondary
objective measures included hepatic PFS, overall survival, safety and
tolerability. Top-line results from the trial's hepatobiliary cohort
[http://www.delcath.com/news-events/news/article/reuters/1598619 ]
were announced August 22, 2011; and from the metastatic colorectal
cohort
[http://www.delcath.com/news-events/news/article/reuters/1602268 ] on
September 1, 2011.

About mNET

Neuroendocrine tumors (NETs) are a group of malignant tumors that
originate from intersections of the nervous system and endocrine
(glandular) system throughout the body and are found in various
locations, such as the pancreas, thyroid, lungs, gastrointestinal
tract and biliary system. Nearly 9,000 patients in Europe have
neuroendocrine tumors metastases in the liver, which is the most
common site for neuroendocrine tumors to metastasize. Surgery is an
accepted treatment for mNETs, but the type and extent of surgery for
liver metastasis is contingent upon tumor size, disease progression,
site of origin and other factors including the age and heath of the
patient. Recent published data from the control arms of randomized
controlled trials in pancreatic NET show that progression-free
survival is of the order of 6 months without treatment.

About the Hepatic CHEMOSAT(R) Delivery System

CHEMOSAT allows the administration of concentrated regional
chemotherapy by isolating the circulatory system of the liver using
specially-designed catheters that are inserted in the groin and sit
in the hepatic artery and inferior vena cava. Once the liver is
isolated, the chemosaturation system delivers high-concentration
chemotherapy, such as melphalan hydrochloride, directly to the liver.
To limit systemic exposure and the related side effects, blood from
the liver is redirected through an isolation-aspiration catheter to
extracorporeal filters, which reduce the concentration of
chemotherapeutic agent in the blood before it is returned to the
patient. The procedure is minimally invasive and repeatable allowing
for multiple courses of treatment.

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 III metastatic melanoma study, and the
Company recently completed a multi-arm Phase II 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 mNET, 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, Inc.
Im Internet recherchierbar: http://www.presseportal.de

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