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): January 31, 2005
DELCATH SYSTEMS, INC.
(Exact name of registrant as specified in its charter)
Delaware 001-16133 06-1245881
(State or other jurisdiction of (Commission File Number) (IRS Employer 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 January 31, 2005, Delcath Systems, Inc. (the "Company") issued a press
release relating to certain preliminary findings by National Cancer Institute
researchers using the Company's technology. The Company's press release dated
January 31, 2005 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) Exhibits:
Exhibit Description
99 Press Release dated January 31, 2005 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: January 31, 2005
EXHIBIT INDEX
Exhibit Description
99 Press Release dated January 31, 2005 of Delcath Systems, Inc.
News From: Delcath Systems, Inc. Redington,Inc.
49 Richmondville, Westport CT 06880
Release Date: IMMEDIATE
Contact:
M.S. Koly Thomas Redington
Chief Executive Officer Redington, Inc.
Delcath Systems, Inc. 203/222-7399
203/323-8668 212/926-1733
www.delcath.com www.redingtoninc.com
--------------- --------------------
National Cancer Institute Reports Encouraging
Results With Delcath Cancer Therapy
Survival Data Reported For First Time
HOLLYWOOD, FL JAN. 31 -Delcath Systems, Inc. (Nasdaq: DCTH) said
National Cancer Institute researchers, using Delcath technology,
achieved encouraging survival and tumor response results in a group of
patients with terminal metastatic melanoma in the liver.
The findings, which are preliminary and include the largest
subset of patients enrolled in the Phase I trial, were reported at the
2005 Gastrointestinal Cancers Symposium held here January 27-29 by NCI
investigator Jeffrey Farma, MD, a colleague of the study's principal
investigator, H. Richard Alexander, MD, head of the NCI's Surgical
Metabolism Section.
The expected average survival time for patients diagnosed with
inoperable cancer in the liver is six to nine months, based on
historical data.
The NCI reported that patients in the Delcath study lived 50 to
120 percent longer than expected, with an overall median survival of
13 months, based on the Kaplan-Meier curve, a widely accepted method
of actuarial analysis. Five of the 15 evaluable patients have lived
longer than 15 months and one remained alive past 20 months. After
lengthier follow-up of patients who are still alive, the survival data
is expected to improve.
The NCI reported that two-thirds of the 15 patients experienced
positive anti-tumor activity ranging from stabilization to a complete
response. Of those, 50 percent experienced either a complete response
or a partial response, which is defined as tumor mass reduction of 50
percent or more. The results were confirmed by radiographic
measurement, which is considered a stringent criterion.
The study was conducted to find the optimal dose of the cancer
drug melphalan using Delcath's patented drug delivery technology.
Researchers also assessed how liver tumors originating from different
types of cancers respond to the experimental therapy. The findings in
this report suggest that melanoma is one of the tumor types that
respond to Delcath therapy.
The Delcath system delivers chemotherapy directly to the liver
via the hepatic artery at much higher doses than is possible with
traditional intravenous therapy. As blood exits the liver, special
Delcath filters trap the
-more-
chemotherapy, protecting the rest of the body from excessive toxicity.
The procedure is repeatable and less invasive than traditional ways of
performing isolated perfusion to effect high-dose therapy of specific
body organs or regions.
Dr. Alexander's research team at the NCI has since started Phase
II clinical studies to provide further data to support the safety and
efficacy claims that will form the basis of eventual applications for
approval to the FDA.
"We're very encouraged by the NCI's most recent findings and we
are especially gratified to learn that our technology has a meaningful
effect on extending survival of patients whose treatment options are
very limited," said Delcath chief executive officer M. S. Koly.
The three-day, multidisciplinary symposium at which the Delcath
data was presented is co-sponsored by the American Society of Clinical
Oncology, the American Gastroenterological Association, the American
Society for Therapeutic Radiology and Oncology, and the Society of
Surgical Oncology. This is the second consecutive year the meeting was
held and also marks the second year a presentation was given on the
use of the Delcath system.
Delcath is a developer of isolated perfusion technology for organ
or region-specific delivery of therapeutic agents. Six U.S. and three
foreign issued patents cover its technology. The company is
headquartered in Stamford, CT.
# # #
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 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.
