d8k20100413.htm

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): April 13, 2010

	DELCATH SYSTEMS, INC.
	(Exact Name of Registrant as Specified in Charter)

	DELAWARE		001-16133		06-1245881
	(State of Incorporation)		(Commission File Number)		(IRS Employer Identification No.)

	600 FIFTH AVENUE, 23RD FLOOR NEW YORK, NEW YORK		10020
	(Address of Principal Executive Offices)		(Zip Code)

Registrant’s telephone number, including area code: (212) 489-2100

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:

[ ] Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

[ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

[ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 7.01 Regulation FD Disclosure.

On April 13, 2010, Delcath Systems, Inc. issued a press release announcing that the American Society of Clinical Oncology (ASCO) has accepted an abstract for oral presentation of Delcath’s Phase III Trial Data comparing percutaneous hepatic perfusion with melphalan (PHP-mel) to the best alternative care for patients with hepatic metastases from ocular or cutaneous melanoma for ASCO’s 2010 Annual Meeting, to be held June 4-8, 2010 at McCormick Place in Chicago. A copy of Delcath’s April 13, 2010 press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

Delcath also reiterated that it expects to report top-line results from its Phase III clinical trial in April 2010.

Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.	The following exhibit is furnished with this report on Form 8-K:

Exhibit Number 99.1	Description of Exhibit Press Release of Delcath Systems, Inc. dated April 13, 2010

SIGNATURES

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.

Date: April 14, 2010

	DELCATH SYSTEMS, INC. By: /s/ David A. McDonald
	Name: David A. McDonald Title: Chief Financial Officer

EXHIBIT 99.1

Delcath’s Phase III Trial Data to be Presented During American Society of Clinical Oncology 2010 Annual Meeting in Chicago

New York, NY -- April 13, 2010 -- Delcath Systems, Inc. (NASDAQ: DCTH), a medical technology company testing its proprietary treatment system for primary and metastatic cancers to the liver, announced today that the American Society of Clinical Oncology (ASCO) has accepted an abstract for oral presentation of Delcath’s Phase III Trial Data comparing percutaneous hepatic perfusion with melphalan (PHP-mel) to the best alternative care for patients with hepatic metastases from ocular or cutaneous melanoma for ASCO’s 2010 Annual Meeting, to be held June 4-8, 2010 at McCormick Place in Chicago.

James F. Pingpank, MD, FACS, Associate Professor of Surgery at the University of Pittsburgh School of Medicine and a lead Principal Investigator of the Phase III trial, will present the abstract on June 5 at 3:30pm CT, during the Melanoma/Skin Cancer – Oral Abstract Session. The company expects to report top-line results from the trial later this month.

“ASCO’s invitation to present at the podium represents a tremendous achievement for the clinicians leading our Phase III trial,” said Eamonn P. Hobbs, Delcath’s President and CEO. “The invitation illustrates the increasing interest in the Delcath PHP System™ as well as the data generated from the trial within the oncology clinician community. We look forward to Dr. Pingpank sharing this data and thank all of the patients and physicians for their involvement in this groundbreaking study.”

About Delcath Systems, Inc.

Delcath Systems, Inc. is a medical technology company specializing in cancer treatment. The Company is testing a proprietary, patented drug delivery system for the treatment of primary and metastatic liver cancers. Delcath's novel drug delivery platform is testing the delivery of ultra-high doses of anti-cancer agents to the liver while controlling the systemic exposure of those agents. In addition to its fully enrolled Phase III metastatic melanoma study, the Company is currently conducting trials to treat other liver cancers. The Company maintains a broad intellectual property portfolio on a worldwide basis including the U.S., Europe, Asia and Canada. For more information, please visit the Company's website at 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 our ability to successfully complete Phase III clinical trials and secure regulatory approval of our current or future drug-delivery system 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. Yo u 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 Information:

Investor Contact:

Doug Sherk/Stacey Fisher/Mike Pollack

EVC Group

415-896-6820

Media Contact:

Steve DiMattia

EVC Group

646-201-5445