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
November
20, 2007 (November 20, 2007)
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
November 20, 2007, Delcath Systems, Inc. (the “Company”) announced that the U.S.
Food and Drug Administration (the “FDA”) has notified the Company that patient
enrollment may resume in the Phase III and Phase II clinical trials of the
Delcath System. Current and prospective clinical investigation sites have been
notified that study accrual can be resumed immediately. This decision follows
the Company’s meeting with representatives of the FDA, along with the Principal
Investigator at the National Cancer Institute (“NCI”).
The
Company’s resumption of study accrual follows a voluntary enrollment deferral
announced by the Company on October 23, 2007 in response to an FDA inquiry
into
certain gastrointestinal adverse events observed in four patients enrolled
in
the studies of the Delcath System prior to protocol changes enacted earlier
this
year. During the meeting at the FDA, which was attended by senior reviewers
from
both the Drug and Device arms of the Agency, the Principal Investigator
presented an analysis of the previously reported gastrointestinal toxicities
and
of the changes incorporated into the trial protocols to prevent a recurrence
of
(GI) toxicities. These changes had been previously approved by the NCI
Institutional Review Board and were subsequently approved by the Data Safety
Monitoring Board for the Phase III trial. The Company has been notified in
writing by the FDA that the studies can proceed with the amended
protocol.
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
|
|
Press
release of the Company dated November 20,
2007
|
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:
November 20, 2007
|
DELCATH
SYSTEMS, INC.
|
|||
|
|
|
By:
|
|
/s/
Richard L. Taney
|
| Name:
Richard L. Taney
Title:
Chief Executive Officer
|
EXHIBIT
INDEX
|
No.
|
Description
|
|
Press
release of the Company dated November 20,
2007
|
|
Company
Contact:
|
Investor
Relations Contacts:
|
|
Delcath
Systems, Inc.
|
Lippert/Heilshorn
& Associates, Inc.
|
|
Richard
Taney
|
Anne
Marie Fields
|
|
(212)
489-2100
|
(afields@lhai.com)
|
|
www.delcath.com
|
(212)
838-3777
|
|
Bruce
Voss (bvoss@lhai.com)
|
|
|
(310)
691-7100
|
|
|
www.lhai.com
|
DELCATH
RESUMES ENROLLMENT IN PHASE III AND PHASE II TRIALS
NEW
YORK
(November 20, 2007) - Delcath Systems, Inc. (NASDAQ:DCTH) announces that the
U.S. Food and Drug Administration (FDA) has notified the Company that patient
enrollment may resume in the Phase III and Phase II clinical trials of the
Delcath System. Current and prospective clinical investigation sites have been
notified that study accrual can be resumed immediately. This decision follows
Delcath's meeting with representatives of the U.S. Food and Drug Administration
(FDA), along with the Principal Investigator at the National Cancer Institute
(NCI).
Resumption
of study accrual follows a voluntary enrollment deferral announced by the
Company on October 23, 2007 in response to an FDA inquiry into certain
gastrointestinal adverse events observed in four patients enrolled in the
studies of the Delcath System prior to protocol changes enacted earlier this
year. During the meeting at the FDA, which was attended by senior reviewers
from
both the Drug and Device arms of the Agency, the Principal Investigator
presented an analysis of the previously reported gastrointestinal toxicities
and
of the changes incorporated into the trial protocols to prevent a recurrence
of
(GI) toxicities. These changes had been previously approved by the NCI
Institutional Review Board (IRB) and were subsequently approved by the Data
Safety Monitoring Board (DSMB) for the Phase III trial. The Company has been
notified in writing by the FDA that the studies can proceed with the amended
protocol.
"We
are
pleased with the Agency's prompt response to and resolution of this issue.
We
are very appreciative of the timely assistance of the NCI which allowed us
to
respond to the Agency less than a week after receiving the letter and their
presentation of the data contributed greatly to the unusually quick resolution
of this matter. A thorough analysis of the clinical facts surrounding these
episodes combined with the clinical benefits demonstrated by the Delcath System
for these extremely ill patients allowed for a balanced evaluation of FDA safety
concerns," said Richard L. Taney, President and Chief Executive Officer of
Delcath Systems.
"We
look
forward to recruiting additional oncology centers for the expansion of our
clinical trials as we believe that use of the Delcath System for the targeted,
region-specific delivery of high
dose
chemotherapeutic agents can bring significant clinical benefit to late-stage
cancer patients with very limited treatment options, and consequently, poor
prognoses, " concluded Mr. Taney.
The
Phase III Trial
The
Phase
III study, now resuming enrollment at the NCI, is testing the Delcath 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 isolates the blood flow within the patient's liver
in
order to allow significantly higher doses of the anti-cancer drug to be
administered while limiting the toxicities that result from current 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 FDA under a Special Protocol Assessment, 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.
The
Phase II Trial
The
Phase
II clinical trial, also resuming enrollment at the NCI, is testing use of the
Delcath System for the organ-specific delivery of the chemotherapeutic agent
melphalan in patients with specific tumors in the liver, including primary
liver
cancer, metastatic neuroendocrine tumors, adenocarcinomas in the liver, and
metastatic melanoma in the liver of patients who previously received isolated
hepatic perfusion, but whose cancer has since returned.
About
Delcath Systems, Inc.
Delcath
Systems is a developmental stage company testing its percutaneous perfusion
technology for the isolated organ and region specific delivery of therapeutic
and chemotherapeutic agents. The Delcath System is currently being tested with
the drug Melphalan in a Phase III trial of patients with metastatic ocular
and
cutaneous melanoma in the liver, and a Phase II trial of patients with primary
liver cancers and metastatic tumors in the liver from neuroendocrine cancers,
adenocarcinomas, as well as patients with melanoma who previously received
isolated perfusion. The Company's intellectual property portfolio currently
consists of eighteen 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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