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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 26, 2004
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 and zip code)
Registrant's telephone number, including area code: (203) 323-8668
N/A
(Former name or former address, if changes since last report)
2
Item 5. Other Events and Regulation FD Disclosure
On January 26, 2004, Delicate Systems, Inc. (the "Company") issued a press
release announcing an update on the experience of the National Cancer Institute
using the Company's system for isolated liver perfusion. The Company's press
release dated January 26, 2004 is incorporated herein by reference and filed as
an exhibit hereto.
Item 7. Financial Statements and Exhibits.
(a) Not applicable
(b) Not applicable.
(c) Exhibits:
Exhibit Description
99 Press Release dated January 26, 2004 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 26, 2004
EXHIBIT INDEX
Exhibit Description
99 Press Release dated January 26, 2004 of Delcath Systems, Inc.
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
NCI STUDY WITH DELCATH CANCER TECHNOLOGY
REPORTS SIGNIFICANT ANTI-TUMOR ACTIVITY
60 Percent of Evaluable Patients Responded To High Dose
Therapy Aimed Directly At Tumor
SAN FRANCISCO, CA. JAN 26 - Delcath Systems, Inc. (Nasdaq:
DCTH/DCTHW/DCTHZ) said researchers from the National Cancer Institute (NCI)
reported an update on their experience using the Delcath system for isolated
liver perfusion at the 2004 Gastrointestinal Cancer Symposium held here Jan.
22-24
Dr. James Pingpank, a Senior Investigator of the NCI Surgical Metabolism
Section and a colleague of the Section's head, Dr. H. Richard Alexander, told
the physicians present that 60 percent of the evaluable cancer patients treated
with high dose therapy through the Delcath system experienced anti-tumor
activity, with over half of the responding patients achieving tumor shrinkage
greater than 50 percent.
Subjects in the study included patients with inoperable primary and
metastatic liver cancers of varying origin.
Of particular importance, the NCI reported that the response rate in
patients with primary ocular melanoma was higher, with anti-tumor activity
observed in 80 percent of evaluable patients.
The NCI study was conducted to determine the optimal dose of the widely
prescribed cancer drug melphalan using Delcath's novel technology, an advanced
form of site-directed drug delivery. It is designed to allow aggressive
chemotherapy by limiting the serious side effects that typically restrict dosing
of toxic cancer chemicals.
Researchers said the findings defined 3.0 mg/kg of melphalan as the optimal
dose to be tested for anti-tumor effect in future protocols. The dose is at
least six times higher than the drug's label recommendation of under 0.5 mg/kg.
This represents a much more aggressive use of melphalan than was originally
thought possible. Patients in the study were treated with doses as high at 3.5
mg/kg, a dose that could never be delivered by conventional methods.
NCI has finished recruiting patients for the Phase I study since the study
goals have been met, but continues to treat and follow enrolled patients for
tumor response.
-more-
The company said the NCI's results follow and in some cases improve the
tumor response trends experienced in earlier Phase I/Phase II studies using a
different drug at MD Anderson and also Yale Medical School where the Delcath
technology was first tested. Company officials point out that one of the
strengths of the Delcath system is its ability to deliver a wide range of
anti-cancer agents. The observation of effects with multiple drug candidates is
an important proof of the system's flexibility with a variety of therapeutic
regimens.
Data from the study, along with data from other NCI studies, has provided
the basis for selecting tumor types to be tested in Phase II trials with the
Delcath system now being planned at multiple centers including the NCI. The
studies will include patients with several tumor types including metastatic
colorectal cancer to the liver. Colorectal cancer, the third most common cancer
in men and women in the U.S., has a high tendency to metastasize to the liver
where it is very difficult to treat. This pervasive disease is responsible for
over 57,000 deaths a year.
The Delcath system delivers high-dose chemotherapy directly to an organ or
body region. In the NCI study, melphalan was delivered to the liver via the
hepatic artery. As blood exits the liver, special Delcath filters trap the
therapeutic agent, decreasing exposure to the rest of the body and reducing
toxicity. The procedure is repeatable and less invasive than traditional ways of
performing isolated perfusion to specific body organs or regions.
The 2004 Gastrointestinal Cancer Symposium (San Francisco) was sponsored by
the American Society of Clinical Oncology (ASCO), American Gastroenterological
Association, American Society for Therapeutic Radiology & Oncology, and the
Society of Surgical Oncology.
The NCI presentation is titled "A Phase I Dose-Escalation Study of Hepatic
Arterial Melphalan Infusion with Hepatic Venous Hemofiltration Using
Percutaneously Placed Catheters in Patients with Unresectable Hepatic
Malignancies." This report to the scientific community provided an update to a
presentation at the June 2003 ASCO meeting by the study's principal
investigator, Dr. H. Richard Alexander, head of the NCI's Surgical Metabolism
Section.
Delcath is a developer of isolated perfusion technology for organ or
region-specific delivery of therapeutic agents. Six US, 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.
1/26/04