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 2, 2007 (March 29, 2007)
DELCATH SYSTEMS, INC.
(Exact name of registrant as specified in its charter)
DELAWARE 001-16133 06-1245881
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(State or other jurisdiction (Commission (IRS Employer
of incorporation) File Number) Identification No.)
1100 SUMMER STREET, STAMFORD, CONNECTICUT 06905
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(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (203) 323-8668
N/A
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(Former name or former address, if changed since last report.)
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):
[ ] Written communications 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 1.01. ENTRY INTO A MATERIAL DEFINITIVE AGREEMENT
On March 29, 2007, Delcath Systems, Inc. (the "Company") announced that it
entered into a five-year extension of its Cooperative Research and Development
Agreement (the "CRADA") with the National Cancer Institute ("NCI"), which
enhances and expands the initial agreement between the Company and NCI that
expired in December 2006. Under the revised CRADA, the Company and NCI agreed
that the parties will collaborate in the joint development and evaluation of the
Delcath System device to deliver high-dose Melphalan to patients and to evaluate
the advisability of developing additional commercial agents for use with the
Delcath System, the Company's percutaneous perfusion technology for
region-specific delivery of chemotherapeutic and other therapeutic agents.
The revised CRADA also established that NCI's Surgery Branch will work towards
completion of Delcath System's ongoing Phase III trial and will serve as the
coordinating center when this study expands to a multi-center trial. The Phase
III trial is treating patients with melanoma (ocular or cutaneous) metastatic to
the liver using the Delcath System and the drug Melphalan.
ITEM 9.01. FINANCIAL STATEMENTS AND EXHIBITS
(a) FINANCIAL STATEMENTS OF BUSINESSES ACQUIRED.
Not applicable.
(b) PRO FORMA FINANCIAL INFORMATION.
Not applicable.
(c) SHELL COMPANY TRANSACTIONS.
Not applicable.
(d) EXHIBITS:
EXHIBIT NO. DESCRIPTION
99.1 Press Release dated March 29, 2007
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.
DELCATH SYSTEMS, INC.
(Registrant)
Date: April 2, 2007 By: /s/ Richard Taney
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Richard Taney, CEO