DELCATH(R) SYSTEMS, INC. LOGO DELCATH SYSTEMS EXTENDS COOPERATIVE RESEARCH AND DEVELOPMENT AGREEMENTResearch and Development Agreement |
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[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






