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): March 1, 2006
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))
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Section 8 - Other Events
Item 8.01 Other Events.
On March 1, 2006, Delcath Systems, Inc. (the "Company") issued a press
release announcing that the first patient has been treated in the Company's
Phase III clinical trial for the treatment of metastatic melanoma in the liver.
The Company's press release dated March 1, 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 March 1, 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: March 1, 2006
EXHIBIT INDEX
Exhibit Description
99 Press Release dated March 1, 2006 of Delcath Systems, Inc.
[GRAPHIC OMITTED]
FOR IMMEDIATE RELEASE
Company Contact: Investor Contacts:
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
- --------------- ---------------- ----------------
Media Contacts:
Lewis Goldberg / Scott Rosenblum
KCSA Worldwide
(212) 896-1216 / (212) 896-1274
lgoldberg@kcsa.com / srosenblum@kcsa.com
- ------------------ -------------------
Delcath Systems Announces Initial Patient Treatment In
Phase III Clinical Trial
STAMFORD, Conn., March 1, 2006 -- Delcath Systems, Inc. (NASDAQ: DCTH), today
announced that the first patient has been treated with the Delcath System in its
pivotal Phase III clinical trial for the treatment of metastatic melanoma in the
liver using the Delcath system with melphalan, an approved anticancer agent at
the National Cancer Institute (NCI).
The NCI is the first site to enroll patients in the Phase III trial with
melphalan. As of February 28, two patients were enrolled and started on therapy.
In accordance with the company's Special Protocol Assessment and Agreement (SPA)
with the U.S. Food and Drug Administration (FDA), announced February 22, 2006,
the multi-center trial requires the enrollment of 92 total patients to determine
whether patients using the Delcath system experience a reduction in tumor burden
or zero progression of the tumor for a longer period of time than those
receiving best alternative care. Patients randomized to the control group whose
tumors progress will be allowed to cross over and receive treatment using the
Delcath system without impacting the study.
"We believe the trial's positive start can be attributed to the establishment of
a protocol the investigators wanted," said M.S. Koly, president and chief
executive officer of Delcath. "While the trial needs to be randomized to provide
a statistically valid result, the FDA has agreed to allow control arm patients
to receive the best alternative care. This removes one of the primary objections
of potential investigators to our previous trial, where the use of a specific
systemic therapy may not be the best for the patient randomized to the control
arm."
"A more important attribute of the randomized trial is the FDA's agreement to
accept progression free survival as the primary endpoint. Progression free
survival is the length of time a patient is both alive and free from any
significant increase in the tumor (free from progression). Control patients
whose tumors grow will have completed their portion of the trial and at the
principal
investigator's judgment will then be permitted to receive the Delcath treatment.
The investigators feel the availability of crossover will greatly speed patient
accrual in this study," explains Mr. Koly.
"Delcath's goal all along has been to bring our system to market as quickly and
safely as possible. We are convinced that the Delcath system is among the best
methods to help many liver cancer patients achieve a significantly better
quality of life while dealing with their disease. The SPA agreement with the FDA
has allowed us to aggressively proceed down the fast track path and we believe
that the enrollment of patients will move quickly, and that the results will
convince the FDA of the efficacy of our product," said Mr. Koly. "In addition to
the NCI, we are lining up other top cancer centers to join our trial and
accelerate patient accrual as we leverage our strong relationships within the
medical community, including Dr. Richard Alexander, the recently appointed
Associate Chairman of Clinical Research at the University of Maryland School of
Medicine in Baltimore."
"While we are excited about commencing the trial, we must follow the NCI's
clinical trial guidelines and will not be able to release material information
regarding the Phase III trial while it is underway unless investigators publish
or present their experiences," Koly concluded.
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 for specific body
organs or regions.
About Special Protocol Assessment and Agreement (SPA)
An SPA is a written agreement from the FDA that the Phase III trial protocol
design, clinical endpoints, and statistical analyses are acceptable to support
regulatory approval, and can only be granted prior to initiation of the clinical
trial. An SPA is binding upon the FDA unless a substantial scientific issue
essential to determining safety or efficacy is identified after testing has
begun.
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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