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 22, 2006
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) (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 February 22, 2006, Delcath Systems, Inc. (the "Company") issued a press
release relating to the completion of a Special Protocol Assessment and
Agreement with the U.S. Food and Drug Administration. The Company's press
release dated February 22, 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 February 22, 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: February 22, 2006
[LOGO]
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 Receives Special Protocol Assessment and Agreement from FDA
- - -
Company to Commence Active Enrollment for Pivotal Phase III Clinical Trial
STAMFORD, Conn., February 22, 2006 -- Delcath Systems, Inc. (Nasdaq: DCTH),
today announced that it has successfully completed a Special Protocol Assessment
and Agreement (SPA) with the U.S. Food and Drug Administration (FDA) for the
treatment of metastatic melanoma in the liver using the Delcath system with
melphalan, an approved anticancer agent.
On February 21st, Delcath received a letter signed by the Acting Director of the
Division of Drug Oncology Products of the FDA stating, "We have completed our
review of your submissions and have determined that your responses are
acceptable..." As a result, active patient enrollment for Delcath's pivotal
Phase III clinical trial at the National Cancer Institute (NCI) is expected to
begin immediately.
Under the terms of the SPA, the company is required to complete one Phase III
trial in order to file a Premarket Approval (PMA) application. The randomized,
multi-center trial will enroll 92 patients diagnosed with ocular and cutaneous
melanoma metastatic to the liver. Patients who are selected to participate in
the trial will be randomized to either the Delcath system using melphalan or a
control group receiving best alternative care. Patients in the control group
will be reviewed on a case-by-case basis and receive an existing treatment
option deemed most appropriate by the principal investigator.
The primary endpoint is to determine whether patients using the Delcath system
will experience a reduction in tumor burden or zero progression of the
metastatic melanoma in their liver longer than those receiving best alternative
care. Participants randomized to the control group whose tumors are found to
progress will be allowed to cross over and receive treatment using the Delcath
system. Results from the point of crossover will not impact the study.
M.S. Koly, president and chief executive officer of Delcath, stated, "The
receipt of SPA approval is a critical step in the advancement of our clinical
program. Combined with the recent approval by the NCI's Internal Review Board of
the same protocol, the SPA enables our company to move forward with our Phase
III study without any further delay and streamlines the FDA approval process.
This is an exciting time for the company, the NCI and its patients."
Dr. James F. Pingpank, Jr., principal investigator for Delcath's clinical trials
at the NCI, said, "The FDA's final approval for the pivotal Phase III clinical
trial protocol serves as an important milestone. Due to the positive results
from the Phase I study conducted at the NCI, and building on results achieved
with melphalan via a surgical approach, we have received a number of referrals
of qualified patients nationwide to participate in the upcoming Phase III trial.
Our plan is to begin the active enrollment of patients into this study effective
immediately."
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.
Special Protocol Assessment
A Special Protocol Assessment (SPA) from the FDA is an agreement that the Phase
III trial protocol design, clinical endpoints, and statistical analyses are
acceptable to support regulatory approval. An SPA is binding upon the FDA unless
a substantial scientific issue essential to determining safety or efficacy is
identified after the testing is begun. For more information please visit the FDA
website: www.fda.gov/CbER/gdlns/protocol.pdf.
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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