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
|