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
July
23, 2008 (July 17, 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
5.02. |
DEPARTURE
OF DIRECTORS OR CERTAIN OFFICERS; ELECTION OF DIRECTORS; APPOINTMENT
OF
CERTAIN OFFICERS; COMPENSATORY ARRANGEMENTS OF CERTAIN
OFFICERS.
|
On
July
17, 2008, Dr. Seymour Fein resigned as the Chief Medical Officer of Delcath
Systems, Inc. (“Delcath” or the “Company”), effective as of that date.
On
July
17, 2008, Delcath announced the addition of two senior executives, Mark
Morrison, M.D., Ph.D., as Chief Medical Officer to oversee the expansion of
clinical activity of the Company's first Phase III clinical trial, and Mr.
John
Talarico as Senior Vice President Regulatory Affairs and Quality
Systems.
CHIEF
MEDICAL OFFICER -- MARK MORRISON, M.D., PH.D.
Board
Certified in Medical Oncology and Internal Medicine, Dr. Morrison brings broad
experience in clinical research of both drugs and devices. Dr. Morrison earned
his M.D. and Ph.D. from the Mt. Sinai School of Medicine in New York City,
where
his thesis explored the potential targeted therapy of melanoma. Following his
internship and residency at Beth Israel Medical Center and Fellowship in Medical
Oncology at Memorial Sloan-Kettering Cancer Center (MSKCC), Dr. Morrison
remained as an instructor in the Clinical Immunology Service, Melanoma Group
at
MSKCC. Dr. Morrison began his career in the pharmaceutical industry with
American Cyanamid, where he served as Clinical Team Leader, with a primary
focus
on the development of therapies with monoclonal antibody conjugates. He
subsequently spent twelve years at Pfizer, beginning in New Product Development,
where his role encompassed both clinical trial conduct and market analysis,
leading to the development of comprehensive product life cycle plans for
Pfizer's Oncology pipeline. Dr. Morrison then moved to the Medical Affairs
division where he led the post-marketing clinical development of the
chemotherapy Camptosar(TM) (irinotecan). Most recently at Pfizer, Dr. Morrison
created and headed a team focused specifically on optimizing the clinical
development of new drug and device products. Dr. Morrison's career also has
included the position of Senior Director, Medical Affairs and Oncology Medical
Section Director, overseeing strategic planning and the conduct of Oncology
clinical trials to lead to regulatory approvals at i3 Research, a global
Clinical Research Organization.
SENIOR
VICE PRESIDENT REGULATORY AFFAIRS AND QUALITY SYSTEMS -- MR. JOHN TALARICO
Mr.
Talarico recently held a similar title at Excelsior Medical and ProRhythm,
Inc.,
manufacturers of Class II and III combination products involving a drug and
device. He has held senior engineering, quality and regulatory roles at a series
of medical device companies, during which time he was responsible for PMA,
IDE
and 510(k) submissions. Besides numerous FDA approvals, Mr. Talarico has also
been successful in gaining international device approvals including the European
CE Mark. He has managed worldwide clinical trials for numerous products and
directed the QA, regulatory and compliance activities through approval and
commercialization.
A
copy of
the press release announcing their appointments is attached as Exhibit
99.1.
| ITEM
9.01 |
FINANCIAL
STATEMENTS AND EXHIBITS.
|
|
No.
|
Description
|
|
99.1
|
Press
release of the Company dated July 17,
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:
July 23, 2008
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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 July 17,
2008
|