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
April
28, 2008 (April 25, 2008)
Date
of
Report (Date of earliest event reported)
DELCATH
SYSTEMS, INC.
(Exact
name of registrant as specified in its charter)
|
Delaware
|
001-16133
|
06-1245881
|
|
(State
or other jurisdiction
of
incorporation)
|
(Commission
File No.)
|
(IRS
Employer
Identification
No.)
|
600
Fifth Avenue, 23rd
Floor
New
York, NY 10020
(Address
of principal executive offices, including zip code)
Registrant's
telephone number, including area code: (212)
489-2100
Check
the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligations of the registrant under any of the following
provisions (see General Instruction A.2. below):
| o |
Written
communications pursuant to Rule 425 under the Securities Act (17
CFR
230.425)
|
| o |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
|
| o |
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act
(17 CFR
240.14d-2(b))
|
| o |
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act
(17 CFR
240.13e-4(c))
|
ITEM
8.01 OTHER
EVENTS.
On
April
25, 2008, Delcath Systems, Inc. (the “Company”) announced that the Institutional
Review Board of the University of Maryland Medical Center (“UMMC”) has approved
UMMC’s participation in the Phase III study of the Company’s Percutaneous
Hepatic Perfusion System for the isolated, high dose delivery of the anti-cancer
agent melphalan to treat inoperable metastatic melanoma in the liver. The
Phase
III study is being led by the National Cancer Institute which previously
approved the study’s expansion to a multi-center trial. The Company and UMMC
have entered into a clinical research agreement enabling the hospital to
immediately begin recruiting and treating patients. H. Richard Alexander,
M.D.,
Professor of Surgery and Associate Chairman for Clinical Research, Surgery
at
the University of Maryland will serve as Principal Investigator of the study
at
this new center.
A
copy of
the Company’s press release announcing the events described above is attached
hereto as Exhibit 99.1 and is incorporated herein by reference.
ITEM
9.01 FINANCIAL
STATEMENTS AND EXHIBITS.
|
(a)
|
Not
applicable.
|
|
(b)
|
Not
applicable.
|
|
(c)
|
Not
applicable.
|
|
(d)
|
Exhibits
|
|
No.
|
Description
|
|
99.1
|
Press
release of the Company dated April 25,
2008
|
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, as amended, the
registrant has duly caused this Current Report on Form 8-K to be signed on
its
behalf by the undersigned thereunto duly authorized.
|
Dated:
April 28, 2008
|
DELCATH
SYSTEMS, INC.
|
|
| |
|
|
| By: | /s/ Richard L. Taney | |
|
Name: Richard L. Taney |
||
| Title: Chief Executive Officer | ||
EXHIBIT
INDEX
|
No.
|
Description
|
|
99.1
|
Press
release of the Company dated April 25,
2008
|
Exhibit
99.1
DELCATH
EXPANDS PHASE III TRIAL FOR METASTATIC MELANOMA
TO
INCLUDE UNIVERSITY OF MARYLAND MEDICAL CENTER
NEW
YORK - April 25, 2008 - Delcath Systems, Inc. (NASDAQ:
DCTH)
announced today that the Institutional Review Board (IRB) of the University
of
Maryland Medical Center (UMMC) has approved UMMC's participation in the Phase
III study of the Company's Percutaneous Hepatic Perfusion (PHP) System for
the
isolated, high dose delivery of the anti-cancer agent melphalan to treat
inoperable metastatic melanoma in the liver. The pivotal, Phase III study
is being led by the National Cancer Institute (NCI), which previously approved
the study's expansion to a multi-center trial.
UMMC
has
also entered into a clinical research agreement with Delcath enabling the
hospital to immediately begin recruiting and treating patients. H.
Richard Alexander, M.D., Professor of Surgery and Associate Chairman for
Clinical Research, Surgery at the University of Maryland will serve as Principal
Investigator of the study at this new center. Dr. Alexander, a recognized
leader in the field of regional cancer therapy, was previously Deputy Director
of the NCI's Center for Cancer Research, and Principal Investigator of the
Phase
I study that was Fast Tracked to this current Phase III study.
“The
diagnosis of liver metastases results in a very poor prognosis for the patient,”
commented Dr. Alexander. “The Delcath System may represent an effective,
minimally toxic means of restoring liver health and improving patient
outcome. UMMC is committed to remaining at the forefront of cancer
research and treatment. We look forward to participating in this NCI-led
pivotal
study and to understanding how this system may benefit patients.”
“Expanding
this Phase III study to premier oncology centers such as UMMC remains a top
priority for the Company, as it allows the Delcath System to reach more patients
desperately in need of new treatment options and expands physician awareness
of
its potential clinical benefit,” said Richard L. Taney, President and CEO of
Delcath Systems. “It is especially exciting to be collaborating with Dr.
Alexander, who pioneered the use of our PHP system with Melphalan while at
the
NCI. Throughout 2008, we expect to expand the study to additional clinical
sites with world-class clinical oncology programs. Several of these sites
are
currently in the process of securing the necessary approvals in order to
join
our clinical trials.”
The
Phase III Study
The
Phase
III study is designed to test Delcath's proprietary PHP System for the regional
delivery of melphalan to the liver to treat patients with metastatic ocular
and
cutaneous melanoma who have unresectable tumors in the liver. The Delcath
System
is designed to deliver significantly higher doses of anti-cancer drugs to
a
patient's liver while preventing entry of the drugs to the rest of the patient's
circulation. This isolation limits toxicities that result from systemic
chemotherapy treatments.
Patients
in the Phase III trial initially are randomized into one of two treatment
arms,
including immediate treatment with melphalan via the Delcath System or treatment
with best alternative care. The study is designed to evaluate the duration
of tumor response in each of the two study arms. Following guidelines
established by U.S. Food and Drug Administration (FDA) under a Special Protocol
Assessment (SPA), when disease progresses in patients enrolled in the best
alternative care arm of the trial, they are permitted to “cross over” and
receive treatment with the Delcath System.
About
University of Maryland Medical Center
The
University of Maryland Medical Center (UMMC) is the heart of the University
of
Maryland Medical System's downtown campus. The hospital provides
comprehensive care for the West Baltimore community and tertiary care for
Maryland and the surrounding area. In partnership with the University of
Maryland School of Medicine, UMMC's vision is to be internationally recognized
for world-class clinical programs distinguished by research and education,
and
strengthened by high-quality clinical care, exceptional customer service
and
operational excellence.
About
Delcath Systems, Inc.
Delcath
Systems is a developmental stage company testing its percutaneous perfusion
technology for the isolated delivery of high doses of therapeutic and
chemotherapeutic agents. The Delcath System is currently being tested with
the drug melphalan in Phase III and Phase II clinical trials. The
Company's intellectual property portfolio currently consists of twenty-eight
patents on a worldwide basis including the U.S., Europe, Asia and Canada.
For more information, please visit the Company's website at www.delcath.com.
The
Private Securities Litigation Reform Act of 1995 provides a safe harbor for
forward-looking statements made by the Company or on its behalf. This news
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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Company
Contact:
Delcath
Systems, Inc.
Richard
Taney
(212)
489-2100
www.delcath.com
Media
Relations Contact:
The
Global Consulting Group
Ivette
Almeida
(646)
284-9455
ialmeida@hfgcg.com