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 24, 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 February 24, 2004, Delicate Systems, Inc. (the "Company") issued a press
release relating to a clinical review meeting sponsored by the Company. The
Company's press release dated February 24, 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 February 24, 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
----------------------
M. S. Koly
President and Chief Executive Officer
Date: February 27, 2004
EXHIBIT INDEX
Exhibit Description
------- -----------
99 Press Release dated February 24, 2004 of Delcath Systems, Inc.
Expert Panel Recommends Testing Delcath System For Colorectal Cancer Metastatic
to the Liver
Tuesday February 24, 8:45 am ET
Panelists See Role for Delcath's Dose Directed Delivery System In Increasing the
Effectiveness of Cancer Drugs in the Pipeline
STAMFORD, Conn., Feb. 24 /PRNewswire-FirstCall/ -- Delcath Systems, Inc.
(Nasdaq: DCTH - News) said it plans to conduct an experimental clinical trial
with patients whose colorectal cancer has metastized to the liver, based on
recommendations of a panel of leading medical oncologists and surgeons at a
company-sponsored clinical review meeting last week.
The purpose of the clinical review was to help establish additional
treatment objectives that would broaden the use of the Delcath system for
different cancers and possibly in combination with other drugs upon FDA
approval.
Seymour Fein, MD, acting medical director of Delcath and a board certified
oncologist, moderated the meeting.
In addition to current studies, the 11-physician panel recommended treating
non-operable colorectal cancer in the liver with high-dose hepatic infusion of
melphalan with the Delcath system together with systemic administration of a
conventional dose of irinotecan, a front-line agent used to treat these cancers.
The panel's belief is that the combination therapy could provide an option for
patients who fail other therapies. The suggested protocol design, which would
test the two-drug therapy against a control using irinotecan alone, is believed
to provide an opportunity for a significant improvement for those patients who
lack other options.
The proposed design, which would be a unique combination of high-dose
targeted therapy with a lower dose of a systemic therapy, would start with a
small Phase I trial to confirm the dosing of both drugs when used together.
Successful clinical trials for this indication would broaden the use of the
Delcath system beyond melanomas, the principal focus of the current Phase III
clinical trial.
There was a feeling by the panelists that a viable trial design might
measure the number of patients whose tumors could be surgically removed or
ablated after treatment with the Delcath system. Although post-treatment
surgeries were not recorded in the company's Phase I melphalan trial at the
National Cancer Institute, several patients in the Phase I/II doxorubicin trial
became operative candidates following several treatments with the Delcath
system. Since surgery - where possible -- is considered the best long-term
treatment for tumors, this is a significant opportunity.
The panel of experts also recommended several other agents it believes will
be good candidates for use within the system. The company will consider these
recommendations when funding allows.
The company currently has a Phase III protocol approved by the US FDA for
melanoma to the liver using doxorubicin and is finalizing plans with the
National Cancer Institute for a Phase II protocol for melphalan against a
variety of liver tumors. The NCI recently completed patient enrollment in a dose
finding study, reporting positive anti-tumor activity and safety at doses never
before attempted with melphalan.
The panel members included: Michael Abecassis, MD, Northwestern Medical
Center (Chicago); Jordan D. Berlin, MD, Vanderbilt Medical Center (Nashville);
Sushil Bhardwaj, MD Mount Sinai (Suffern, NY) Hoo G. Chun, MD, New York Medical
College (Vahalla, NY); Marcela Facciutto, MD, Westchester Medical Center
(Vahalla, NY); Dido Franceschi, University of Miami (Miami, FL), William Hait,
MD, Cancer Institute of New Jersey (New Brunswick); Lawrence Helson, MD
(Quakertown, PA) Leonard Makowka, MD, Ceders Sinai (Los Angeles); Yehuda Z.
Patt, MD, Greenbaum Cancer Center (Baltimore); and Harry Wanebo, MD, Roger
Williams Hospital (Providence, RI).
Dr. Harry Wanebo who also is Adjunct Professor of Surgery at Brown
University Medical School and who is planning to participate in the Phase III
trial, expressed enthusiasm for the additional trials discussed at the meeting.
Dr. Dido Franceshia of the University of Miami suggested his medical
facility might be a productive site for the company's current Phase III protocol
due to the incidence of melanoma in Florida.
Of longer-term interest, several of the physicians felt the Delcath system
may have utility for continuing treatment of liver cancers following initial
surgical removal or ablation of detectable tumors. Many of these patients will
not currently receive surgery due to the lack of effective post-surgical
treatments.
The panel's enthusiasm for the Delcath system suggests a broadening
acceptance of Delcath's technology by medical thought leaders.
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.
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