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): September 30, 2004
DELCATH SYSTEMS, INC.
(Exact name of registrant as specified in its charter)
Delaware 001-16133 06-1245881
(State or other jurisdiction (Commission File Number) (IRS Employer
of incorporation) Identification No.)
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))
2
Section 8 - Other Events
Item 8.01 Other Events.
On September 30, 2004, Delcath Systems, Inc. (the "Company") issued a press
release relating to the commencement at the National Cancer Institute of a Phase
II clinical trial using the Company's technology to deliver high dosages of
melphalan for patients with inoperable cancers in the liver. The Company's press
release dated September 30, 2004 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 September 30, 2004 of Delcath
Systems, Inc.
3
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
-----------------------
President and Chief Executive Officer
Date: September 30, 2004
EXHIBIT INDEX
Exhibit Description
99 Press Release dated September 30, 2004 of Delcath
Systems, Inc.
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 OPENS SECOND CANCER TRIAL WITH DELCATH TECHNOLOGY
Phase II Study Is Testing Delcath-Melphalan
Therapy Against Three Types Of Liver Cancers
STAMFORD, CT SEPT. 30 - Delcath Systems, Inc. (Nasdaq: DCTH) said the
National Cancer Institute has started treating patients in a Phase II clinical
trial using the company's technology to deliver high doses of melphalan for
patients with inoperable cancers in the liver.
This is the NCI's second human study of the company's novel delivery system
with melphalan. The first patient has been enrolled and successfully treated
this past week, the company reported, and NCI researchers are scheduling
additional patients for treatment in the coming weeks.
The Delcath technology was originally developed by physicians at the Yale
University School of Medicine as rescue therapy for patients with inoperable
cancers lodged in specific organs such as the liver, the current focus. No
effective treatments are available for the vast majority of cancers once they
reach the liver, and patients diagnosed with liver cancers generally survive
only nine months on average.
Based on the findings of its first study, the NCI decided to test
Delcath-melphalan therapy in three types of inoperable liver tumors: primary
liver cancers, neuro-endocrine tumors and adenoid carcinomas that have spread to
the liver.
The NCI's earlier work, a Phase I dose-finding study, demonstrated positive
results among patients with a broad variety of liver cancers. Sixty percent of
the evaluable cancer patients experienced anti-tumor activity, according to NCI
researchers, with over half the responding patients achieving tumor shrinkage of
greater than 50 percent.
Positive results from the new trial could potentially accelerate use of
Delcath's patented technology for a broader range of cancers than was originally
anticipated at this stage.
In the new study, up to 25 patients will be enrolled in each of the three
disease groups, and each will receive up to four melphalan treatments with the
Delcath system. The dosing will be the same as the optimal dose determined in
the NCI's Phase I trial for melphalan using
-more-
the drug delivery system, a dose level six times higher than under conventional
methods.
There is no control group. The end points are tumor response and the
duration of tumor response.
The Delcath system uses special catheters and filters to direct and trap
toxic anticancer chemicals so they can be delivered in high doses to body
regions or organs while protecting the rest of the body from excessive toxicity.
"The NCI Phase II multi-cancer protocol is a watershed in moving our
technology forward toward a broader base of utility at an earlier time than we
had originally planned," said M.S. Koly, chief executive officer of Delcath.
"Principal Investigator Richard Alexander, MD and his team of oncologists at the
NCI continue to communicate strong faith in our technology, and they are doing
an excellent job in expanding clinical knowledge of its versatility against
different cancers." NCI researchers are also drafting another protocol using the
Delcath system.
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.
The company's most advanced study, a multi-center Phase III registration
trial using the anticancer drug doxorubicin, is treating patients with
inoperable melanoma in the liver.
# # #
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.
9/30/04