<SEC-DOCUMENT>0001341004-11-001811.txt : 20110928
<SEC-HEADER>0001341004-11-001811.hdr.sgml : 20110928
<ACCEPTANCE-DATETIME>20110928160253
ACCESSION NUMBER:		0001341004-11-001811
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		4
CONFORMED PERIOD OF REPORT:	20110923
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20110928
DATE AS OF CHANGE:		20110928

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			DELCATH SYSTEMS INC
		CENTRAL INDEX KEY:			0000872912
		STANDARD INDUSTRIAL CLASSIFICATION:	SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841]
		IRS NUMBER:				061245881
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-16133
		FILM NUMBER:		111112138

	BUSINESS ADDRESS:	
		STREET 1:		810 SEVENTH AVENUE
		STREET 2:		FL 35
		CITY:			NEW YORK
		STATE:			NY
		ZIP:			10019
		BUSINESS PHONE:		212-489-2100

	MAIL ADDRESS:	
		STREET 1:		810 SEVENTH AVENUE
		STREET 2:		FL 35
		CITY:			NEW YORK
		STATE:			NY
		ZIP:			10019
</SEC-HEADER>
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<FILENAME>delcath_8k.htm
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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="center"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 12pt; FONT-WEIGHT: bold">CURRENT REPORT</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="center"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 12pt; FONT-WEIGHT: bold">SECURITIES EXCHANGE ACT OF 1934</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="center"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 12pt">Date of report (Date of earliest event reported): <font style="DISPLAY: inline; FONT-WEIGHT: bold">September 28, 2011 (September</font> <font style="DISPLAY: inline; FONT-WEIGHT: bold">23, 2011)</font></font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="center"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman Bold, Times New Roman, serif; FONT-SIZE: 16pt; FONT-WEIGHT: bold">DELCATH SYSTEMS, INC.</font></div>

<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="center"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 12pt">(Exact name of registrant as specified in its charter)</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="center"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 12pt">810 Seventh Avenue, 35<font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top">th</font> Floor, New York, New York, 10019</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="center"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 12pt">(Former name or former address, if changed since last report)</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 12pt">Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 12pt; FONT-WEIGHT: bold">Item 8.01. Other Events.</font></div>

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<div style="TEXT-INDENT: 36pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 12pt">On September 23, 2011, Delcath Systems, Inc. issued a press release announcing that updated investigator results from the Phase 3 randomized trial of Delcath&#8217;s chemosaturation system with melphalan in patients with hepatic metastases from ocular or cutaneous melanoma were presented at the European Multidisciplinary Cancer Congress held in Stockholm, Sweden.&#160;&#160;A copy of the press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.</font></div>

<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify">&#160;</div>

<div style="TEXT-INDENT: 36pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 12pt">On September 25, 2011, Delcath Systems, Inc. issued a press release announcing that additional data<font style="DISPLAY: inline"> from the metastatic neuroendocrine tumor (mNET) cohort of Delcath&#8217;s recently completed Phase 2 clinical trial of its chemosaturation system were </font>presented at <font style="DISPLAY: inline">the</font><font style="FONT-STYLE: italic; DISPLAY: inline">&#160;</font><font style="DISPLAY: inline">European Multidisciplinary Cancer Congress held in Stockholm, Sweden.&#160;&#160;</font>A copy of the press release is filed as Exhibit 99.2 to this Current Report on Form 8-K and incorporated herein by reference.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 12pt">The following exhibits are filed herewith:</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: times new roman, serif; FONT-SIZE: 12pt">99.1</font></div>
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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: times new roman, serif; FONT-SIZE: 12pt">Press Release of Delcath Systems, Inc., dated September 23, 2011</font></div>
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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: times new roman, serif; FONT-SIZE: 12pt">99.2</font></div>
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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: times new roman, serif; FONT-SIZE: 12pt">Press Release of Delcath Systems, Inc., dated September 25, 2011</font></div>
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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 12pt"><font id="TAB1" style="MARGIN-LEFT: 36pt"></font>Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="center"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 12pt; FONT-WEIGHT: bold">DELCATH ANNOUNCES UPDATED EFFICACY RESULTS FROM PHASE 3 TRIAL OF CHEMOSATURATION FOR MELANOMA METASTASES IN THE LIVER PRESENTED AT EUROPEAN MULTIDISCIPLINARY CANCER CONGRESS</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="center"><font style="FONT-STYLE: italic; DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 12pt">March 2011 Data Confirm Strong Treatment Effect of Chemosaturation</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 12pt">NEW YORK and STOCKHOLM, SWEDEN, September 23, 2011 &#8211; Delcath Systems (NASDAQ: DCTH) 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&#8217;s chemosaturation system with melphalan in patients with hepatic metastases from ocular or cutaneous melanoma.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 12pt">Dr. Pingpank, a lead principal investigator of the Phase 3 trial, will present the abstract (<font style="DISPLAY: inline; FONT-FAMILY: Calibri, sans-serif; FONT-SIZE: 11pt">9304)</font>, &#8220;Percutaneous Hepatic Perfusion (PHP) vs. Best Alternative Care (BAC) for Patients with Melanoma Liver Metastases - Efficacy Update of the Phase 3 Trial,&#8221;&#160;&#160;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.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 12pt">With respect to the study&#8217;s primary endpoint of hepatic progression free survival (&#8220;hPFS&#8221;), 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&lt;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&lt;0.0001).</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 12pt">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&lt;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</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 12pt">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.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 12pt">&#8220;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,&#8221; said Eamonn P. Hobbs, President and CEO of Delcath. &#8220;The hepatic PFS, overall PFS and response rate are consistent with past investigator assessments and highly statistically significant.&#160;&#160;We are encouraged by the data presented in Stockholm today.&#8221;</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="FONT-STYLE: italic; DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 12pt; FONT-WEIGHT: bold"><font style="DISPLAY: inline; TEXT-DECORATION: underline">About Delcath Systems</font></font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 12pt">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 <font style="DISPLAY: inline; COLOR: #0000ff; TEXT-DECORATION: underline">http://www.delcath.com/</font>.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="FONT-STYLE: italic; DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 12pt">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</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="center"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 12pt; FONT-WEIGHT: bold">DELCATH ANNOUNCES FURTHER RESULTS FROM NEUROENDOCRINE TUMOR COHORT PRESENTED AT EUROPEAN MULTIDISCIPLINARY CANCER CONGRESS</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 11pt"><font style="DISPLAY: inline">NEW YORK and STOCKHOLM, SWEDEN, September 25, 2011 &#8211;Delcath Systems (NASDAQ: DCTH) announced that </font>James F. Pingpank, MD, FACS, Associate Professor of Surgery at the University of Pittsburgh School of Medicine, will present a poster today that includes additional data<font style="DISPLAY: inline"> from the metastatic neuroendocrine tumor (mNET) cohort of Delcath&#8217;s&#160;&#160;recently completed Phase 2 clinical trial of its chemosaturation system. </font>The poster being presented at <font style="DISPLAY: inline">the</font><font style="FONT-STYLE: italic; DISPLAY: inline">&#160;</font><font style="DISPLAY: inline">European Multidisciplinary Cancer Congress in Stockholm includes the data previously presented in Dr. Pingpank&#8217;s late-breaking abstract at the </font>Cardiovascular and Interventional Radiological Society of Europe (CIRSE) congress <font style="DISPLAY: inline">on September 12, 2011 as well as an additional secondary endpoint of median </font>hepatic progression-free survival (hPFS) of 15.5 months. <font style="DISPLAY: inline">The mNET cohort is only one of four cohorts in this Phase 2 trial.</font></font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 11pt">In this mNET cohort, 24 patients with unresectable mNET in the liver underwent an average of three chemosaturation procedures with concentrated melphalan and subsequent extra-corporeal venous hemofiltration. Dr. Pingpank will also present the updated hepatic response rate of 70% in 20 evaluable patients, and median overall survival of 30.4 months in all 24 patients on an intent-to-treat basis, as presented at CIRSE.<font style="DISPLAY: inline; COLOR: #333333">&#160;</font>The safety profile of the chemosaturation system remains consistent with that previously reported for the Company's Phase 3 melanoma trial.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 11pt"><font style="DISPLAY: inline">&#8220;Currently available treatment options for patients with unresectable neuroendocrine liver metastases have response rates around 5%. The anti-tumor activity, disease control 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&#8221; said Eamonn P. Hobbs, President &amp; CEO of Delcath. </font>The data presented today add to those presented at CIRSE, and we believe these data affirm the treatment effect of chemosaturation on liver metastases of NET as seen in the Phase 2 study as well as provide a solid efficacy signal in a tumor type other than melanoma. &#8221;</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 11pt">Conducted at the National Cancer Institute (NCI), this Phase 2 clinical trial included four patient cohorts: 1) primary hepatobiliary cancers and metastatic cancers of 2) neuroendocrine, 3) ocular or cutaneous melanoma, and 4) colorectal (adenocarcinoma) origins. Top-line results from the trial&#8217;s <font style="DISPLAY: inline; COLOR: #0070c0; TEXT-DECORATION: underline">hepatobiliary cohort </font>were announced August 22, 2011, and from the <font style="DISPLAY: inline; COLOR: #0070c0; TEXT-DECORATION: underline">metastatic colorectal cohort </font>on September 1, 2011. The primary objectives were to determine the hepatic 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.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 11pt">Delcath has previously described Phase1/2 NCI-led trial results on 23 patients with mNET that were presented at the 2008 American Hepato-Pancreato-Biliary Association annual meeting.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 11pt">These results included patients from a Phase 1 trial with patients that been enrolled in the Phase 2 trial up to that time.&#160;&#160;The neuroendocrine cohort of the current, completed Phase 2 trial consisted of 24 patients, all of whom were enrolled in the Phase 2 trial.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 11pt; FONT-WEIGHT: bold">About mNET</font></div>

<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 11pt">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.<font style="DISPLAY: inline; FONT-SIZE: 12pt"> An estimated </font>9,000 patients in Europe are diagnosed annually with neuroendocrine tumor 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 and distribution, disease progression, site of origin and other factors including the age and health of the patient. Recently 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.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 11pt; FONT-WEIGHT: bold">About Delcath Systems</font></div>

<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 11pt"><font style="DISPLAY: inline">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</font> Company's website at <font style="DISPLAY: inline; COLOR: #0000ff; TEXT-DECORATION: underline">http://www.delcath.com</font>.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="FONT-STYLE: italic; DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 11pt">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</font></div>

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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
