UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 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): February 7, 2006
DELCATH SYSTEMS, INC.
(Exact name of registrant as specified in its charter)
Delaware 001-16133 06-1245881
(State or other (Commission File Number) (IRS Employer
jurisdiction of Identification No.)
incorporation)
1100 Summer Street, Stamford, Connecticut 06905
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (203) 323-8668
N/A
(Former name or former address, if changes 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))
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Section 8 - Other Events
Item 8.01 Other Events.
On February 7, 2006, Delcath Systems, Inc. (the "Company") issued a press
release relating to the approval by the Institutional Review Board of the
National Cancer Institute of a Phase III clinical trial using the Company's
technology to deliver high dosages of melphalan for treatment of metastatic
melanoma in the liver. The Company's press release dated February 7, 2006 is
incorporated herein by reference and filed as an exhibit hereto.
Section 9 - Financial Statements and Exhibits
Item 9.01. Financial Statements and Exhibits.
(a) Not applicable
(b) Not applicable.
(c) Not applicable.
(d) Exhibits:
Exhibit Description
99 Press Release dated February 7, 2006 of Delcath Systems, Inc.
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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.
By: /s/ M. S. KOLY
-----------------------------
M. S. Koly
President and Chief Executive
Officer
Date: February 7, 2006
[DELCATH LOGO]
FOR IMMEDIATE RELEASE
Contact:
Delcath Systems, Inc. Todd Fromer / Michael Cimini
M. S. Koly, Chief Executive Officer KCSA Worldwide
203-323-8668 (212) 896-1215 / (212) 896-1233
www.delcath.com tfromer@kcsa.com / mcimini@kcsa.com
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Delcath Systems Receives NCI Institutional Review Board Approval
STAMFORD, Conn., February 7, 2006 -- Delcath Systems, Inc. (Nasdaq: DCTH), today
announced the National Cancer Institute (NCI) Institutional Review Board (IRB)
has approved the Company's pivotal Phase III clinical trial for the treatment of
metastatic melanoma in the liver with melphalan, an approved anticancer agent.
With IRB approval, Delcath and the NCI will be able to initiate the recruitment
of patients for its Phase III clinical trial immediately following the U.S. Food
and Drug Administration (FDA) protocol approval. In May 2005, the FDA granted
fast-track status for the company's Phase III clinical trial. By scheduling the
Phase III trial to start after receiving the FDA's protocol approval, Delcath
will maintain its eligibility for Special Protocol Assessment (SPA) status, a
written agreement that allows Delcath to receive official FDA evaluation on its
Phase III trials that form the basis of final FDA approval.
The Delcath system delivers high-dose chemotherapy directly to the liver via the
hepatic artery. As blood exits the liver, special Delcath filters trap the
chemotherapy, protecting the rest of the body from excessive toxicity. The
procedure is repeatable and is less invasive than traditional surgical ways of
performing isolated perfusion to effect dose-directed therapy of specific body
organs or regions.
M.S. Koly, President and Chief Executive Officer of Delcath Systems, stated, "We
are pleased with the decision of NCI's IRB to approve our Phase III study. This
approval will help us quickly initiate the trial at the NCI once we receive
final protocol approval from the FDA. Our plan is to receive the SPA prior to
commencing our Phase III trial in order to take full advantage our FDA
fast-track status.
"Delcath continues to enhance its strategic position leading up to its Phase III
clinical trial. In addition to IRB approval, recently we increased our financial
strength through exercise of outstanding warrants and completion of a $2.5
million private placement. We believe this additional capital solidifies our
ability to execute our Phase III trial at multiple centers throughout the
approval process."
About Delcath Systems, Inc.
Delcath Systems is a developer of isolated perfusion technology for organ or
region-specific delivery of therapeutic agents. The company's intellectual
property portfolio currently consists of 12 patents on a worldwide basis,
including the United States, Europe, Asia and Canada.
For more information, please visit the Company's website, www.delcath.com.
This release contains "forward-looking statements" based on current expectations
but involving known and unknown risks and uncertainties. Actual results or
achievements may be materially different from those expressed or implied.
Delcath's plans and objectives are based on assumptions involving judgments with
respect to future economic, competitive and market conditions, its ability to
consummate, and the timing of, acquisitions and future business decisions, all
of which are difficult or impossible to predict accurately and many of which are
beyond its control. Therefore, there can be no assurance than any
forward-looking statement will prove to be accurate.
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