UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 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) April 2, 2007 (March 29, 2007)
DELCATH SYSTEMS, INC.
(Exact name of registrant as specified in its charter)
DELAWARE 001-16133 06-1245881
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(State or other jurisdiction (Commission (IRS Employer
of incorporation) File Number) Identification No.)
1100 SUMMER STREET, STAMFORD, CONNECTICUT 06905
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(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (203) 323-8668
N/A
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(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))
ITEM 1.01. ENTRY INTO A MATERIAL DEFINITIVE AGREEMENT
On March 29, 2007, Delcath Systems, Inc. (the "Company") announced that it
entered into a five-year extension of its Cooperative Research and Development
Agreement (the "CRADA") with the National Cancer Institute ("NCI"), which
enhances and expands the initial agreement between the Company and NCI that
expired in December 2006. Under the revised CRADA, the Company and NCI agreed
that the parties will collaborate in the joint development and evaluation of the
Delcath System device to deliver high-dose Melphalan to patients and to evaluate
the advisability of developing additional commercial agents for use with the
Delcath System, the Company's percutaneous perfusion technology for
region-specific delivery of chemotherapeutic and other therapeutic agents.
The revised CRADA also established that NCI's Surgery Branch will work towards
completion of Delcath System's ongoing Phase III trial and will serve as the
coordinating center when this study expands to a multi-center trial. The Phase
III trial is treating patients with melanoma (ocular or cutaneous) metastatic to
the liver using the Delcath System and the drug Melphalan.
ITEM 9.01. FINANCIAL STATEMENTS AND EXHIBITS
(a) FINANCIAL STATEMENTS OF BUSINESSES ACQUIRED.
Not applicable.
(b) PRO FORMA FINANCIAL INFORMATION.
Not applicable.
(c) SHELL COMPANY TRANSACTIONS.
Not applicable.
(d) EXHIBITS:
EXHIBIT NO. DESCRIPTION
99.1 Press Release dated March 29, 2007
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.
(Registrant)
Date: April 2, 2007 By: /s/ Richard Taney
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Richard Taney, CEO
[DELCATH(R) SYSTEMS, INC. LOGO]
DELCATH SYSTEMS EXTENDS COOPERATIVE RESEARCH AND DEVELOPMENT
AGREEMENT WITH THE NATIONAL CANCER INSTITUTE
5-YEAR AGREEMENT PROVIDES FOR EXPANDED DEVELOPMENT OF DELCATH'S REGIONAL
CANCER THERAPY
STAMFORD, CT, MARCH 29, 2007-Delcath Systems, Inc. (Nasdaq: DCTH) today
announced that the Company has signed a five year extension to its Cooperative
Research and Development Agreement ("CRADA") with the National Cancer Institute
("NCI"). This extension enhances and expands the initial CRADA that expired in
December 2006. The new five year extension provides for the Company and the NCI
to collaborate in the joint development and evaluation of the Delcath Systems
device to deliver high-dose Melphalan to patients, and to evaluate the
advisability of developing additional commercial agents for use with the Delcath
System, the Company's percutaneous perfusion technology for region-specific
delivery of chemotherapeutic and other therapeutic agents.
Under the new agreement, the Surgery Branch of the NCI will work towards
completion of Delcath System's pivotal ongoing Phase III trial for patients with
metastatic melanoma in the liver using the drug Melphalan, and is expected to
serve as the coordinating center when this study expands to a multi-center
trial. The Phase III study is treating patients with ocular and cutaneous
melanoma who have unresectable tumors in the liver, using the Delcath System to
deliver the drug. The Delcath System is designed to isolate the patient's liver
in order to allow significantly higher dosing of Melphalan while limiting the
systemic toxicities that result from current intravenous chemotherapy
treatments.
Patients in the Phase III trial are randomly assigned to one of two initial
treatment arms, for immediate treatment with Melphalan via the Delcath System,
or alternatively, treatment with best alternative care. The study is designed to
evaluate the duration of tumor response in each of the two arms of the study.
Following the guidelines established by the FDA for this trial under a Special
Protocol Assessment, when the disease progresses (tumor grows) in patients
receiving best alternative care, they are allowed to "cross over" and receive
treatment with the Delcath System. The FDA has approved expansion of the trial
to include up to 15 centers. Upon appropriate NCI Institutional Review Board
("IRB") approval (currently pending), this trial will be expanded to a
multi-center trial.
The NCI will continue conducting the Phase II clinical study of Melphalan in
patients with primary and metastatic hepatic malignancies using the Delcath
System. One of the arms of this multi-histology study was recently expanded to
include twenty-five patients after showing tumor response in 75% of the patients
treated to date. These results generated significant interest among cancer
researchers when they were presented at a recent international cancer symposium
this past February. The NCI will also conduct pharmacokinetic analyses of
patient samples in the Phase II and Phase III clinical trials to characterize
the pharmacokinetic advantage of Melphalan delivered to the liver using the
Delcath System, will provide and perform primary database management and
statistical analysis for the Melphalan trials, and will conduct ongoing
hematological biocompatibility and extraction testing of Melphalan in human
plasma and whole blood.
In addition, the NCI may perform preclinical animal and filter testing to
provide the basis for supporting Phase I trials for additional
chemotherapeutics. Investigating different chemotherapeutics such as
Oxaliplatin, along with development of additional protocols utilizing the
Delcath System for the isolated treatment of cancers in other body regions (such
as colorectal, limb and pancreatic), may be conducted by mutual agreement of
Delcath and the NCI.
Richard L. Taney, Chief Executive Officer of Delcath Systems, commented on the
agreement, "We are very pleased to have reached an expanded CRADA with the NCI.
This is a significant milestone for Delcath as it allows us to continue our
collaboration with the world's premier oncology researchers and clinicians in
order to advance the clinical development of the Delcath System, thereby
bringing regional cancer therapy to patients with limited treatment options.
Importantly, it provides for the expected expansion of the current Phase III
trial into a multi-center trial, which should accelerate patient recruitment and
propel the Delcath System toward commercialization."
"The breadth of this five-year agreement underscores the potential for our organ
or region-specific delivery of therapeutic agents to better treat cancer
patients. This enhanced collaboration allows for the potential expansion of our
platform perfusion technology to other approved chemotherapeutics via the
Delcath System, a goal which remains a primary strategic objective of our
company" concluded Mr. Taney.
ABOUT THE NATIONAL CANCER INSTITUTE
The National Cancer Institute, established under the National Cancer Institute
Act of 1937, is the Federal Government's principal agency for cancer research
and training. The National Cancer Institute coordinates the National Cancer
Program, which conducts and supports research, training, health information
dissemination, and other programs with respect to the cause, diagnosis,
prevention, and treatment of cancer, rehabilitation from cancer, and the
continuing care of cancer patients and the families of cancer patients
ABOUT DELCATH SYSTEMS, INC.
Delcath Systems is a developer of percutaneous perfusion technology for organ or
region-specific delivery of therapeutic and chemotherapeutic 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.