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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): February 26, 2007
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 changed 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 February 26, 2007, Delcath Systems, Inc. (the "Company") issued a press
release reporting interim results from its ongoing Phase II multi-histology
trial of the treatment of unresectable primary and metastic cancers of the liver
using the Company's drug-delivery system with melphalan. Further information
concerning this announcement is contained in the Company's press release dated
February 26, 2007, a copy of which is filed as Exhibit 99 hereto and which is
incorporated herein by reference.
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 February 26, 2007 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/ RICHARD TANEY
-----------------------------
Richard Taney
Chief Executive Officer
Date: February 27, 2007
EXHIBIT INDEX
Exhibit Description
99 Press Release dated February 26, 2007 of Delcath
Systems, Inc.
[GRAPHIC OMITTED]
Company Contact Investor Contacts:
Delcath Systems, Inc. Todd Fromer / Garth Russell
Richard Taney KCSA Worldwide
203-323-8668 (212) 896-1215 / (212) 896-1250
www.delcath.com tfromer@kcsa.com / grussell@kcsa.com
- --------------- ---------------- -----------------
Media Contact:
Lewis Goldberg
KCSA Worldwide
(212) 896-1216
lgoldberg@kcsa.com
- ------------------
FOR IMMEDIATE RELEASE
Delcath Systems Reports Positive Data From Ongoing Phase II
Multi-Histology Trial at the Second International Symposium on
Regional Cancer Therapies
---
Interim Data Supports Expansion of Neuroendocrine Arm of Delcath's Phase II
Trial
San Juan, Puerto Rico, Feruary 26, 2007 -- Delcath Systems, Inc. (Nasdaq: DCTH)
today reported encouraging interim results from its ongoing Phase II
multi-histology trial of the treatment of unresectable primary and metastatic
cancers of the liver using the Delcath system with melphalan. The trial began
under a Cooperative Research and Development Agreement (CRADA) between the
National Cancer Institute ("NCI") and Delcath Systems, Inc. James F. Pingpank,
M.D. of the NCI Surgery Branch is the Principal Investigator of the clinical
study.
During the Second International Symposium on Regional Cancer Therapies in San
Juan, Puerto Rico, William Burns, M.D. presented data from the completed Phase I
trial and the neuroendocrine arm of the Phase II multi-histology trial in a
session entitled, "Percutaneous Liver Perfusion for Patients with Metastatic
Neuroendocrine Tumors." The presentation revealed that of the 14 patients for
which data is currently available, 12 were evaluable, and that objective tumor
responses, including partial and complete responses, were observed in nine of
the 12 patients (75%) treated using the Delcath system with melphalan.
Furthermore, Dr. Pingpank reported that a significant and durable tumor response
was observed in patients with large volume, unresectable hepatic metastases. Dr.
Pingpank is continuing to gather response and survival data in these patients.
The Phase II protocol requires at least a partial response in a minimum of four
of the 14 patients within each trial arm before expanding the respective trial
arm to 25 patients. Therefore, these interim results support the expansion of
the neuroendocrine arm of the Phase II multi-histology trial by the NCI from 14
patients to full enrollment, or 25 patients. Upon completion of the expanded
neuroendocrine arm of the Phase II multi-histology trial and FDA approval, the
neuroendocrine arm
of the trial could then advance to Phase III testing. Enrollment continues in
the other two arms of this trial.
Richard Taney, Chief Executive Officer of Delcath Systems, said, "With our
pivotal study on the treatment of metastatic melanoma in the liver already
underway at the NCI, today's promising results underscore the Delcath system's
potential as a highly-effective regional therapy for the treatment of various
forms of cancer that have metastasized to the liver. We are excited that the NCI
plans to expand the neuroendocrine arm of this study and continues to accumulate
favorable data as a result of their work with the Delcath system."
Taney concluded, "We are proud to be sponsors of the International Symposium on
Regional Cancer Therapies for the second consecutive year. As a leader in
isolated perfusion technologies, Delcath is dedicated to fostering greater
awareness of the progress being made in regional cancer therapies. We strongly
support this unique forum for emerging therapies and the open exchange of ideas
among such distinguished members of the medical community."
The Symposium was sponsored by the David C. Koch Regional Perfusion Cancer
Therapy Center of the University of Pittsburgh Cancer Centers.
The Second International Symposium serves as a comprehensive forum to promote
the research, development and application of the most recent advances in
regional therapies in surgical oncology, while supporting the exchange of
information among healthcare professionals. The course co-directors at the event
include Dr. H. Richard Alexander, Professor of Surgery, University of Maryland
Medical Center, Dr. David L. Bartlett, Professor of Surgery, University of
Pittsburgh School of Medicine, and Dr. Robert P. Edwards, Visiting Professor
Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh
School of Medicine.
In attendance at the symposium were physicians and nurses practicing in the
areas of medical, surgical, thoracic and gynecologic oncology and
gastroenterology and researchers involved in the field of hyperthermia and
regionally applied biologic therapies. For more information on the symposium
please visit www.regionaltherapies.com.
About Delcath Systems, Inc.
Delcath Systems is a developer of percutaneous 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, which are subject to certain
risks and uncertainties that can cause actual results to differ materially from
those described. Factors that may cause such differences include, but are not
limited to, uncertainties relating to our ability to successfully complete Phase
III clinical trials and secure regulatory approval of our current or future
drug-delivery system and uncertainties regarding our ability to obtain financial
and other resources for any research, development and commercialization
activities. These factors, and others, are discussed from time to time in our
filings with the Securities and Exchange Commission. You should not place undue
reliance on these forward-looking statements, which speak only as of the date
they are made. We undertake no obligation to publicly update or revise these
forward-looking statements to reflect events or circumstances after the date
they are made.
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