Delcath to Initiate Expanded Access Treatment Program for PHP System With Melphalan
16 February 2010 - 10:30PM
PR Newswire (US)
Company Updates Phase III Trial Data Analysis Timetable NEW YORK,
Feb. 16 /PRNewswire-FirstCall/ -- Delcath Systems, Inc. (NASDAQ:
DCTH), which is testing its proprietary treatment system for
metastatic cancers to the liver, announced today that the U.S. Food
and Drug Administration ("FDA") will allow the Company to initiate
an Expanded Use - Intermediate Size Population protocol for the
hepatic arterial infusion of melphalan with venous filtration via
the Delcath PHP System(TM) for patients with ocular and cutaneous
melanoma metastatic to the liver. Expanded access programs make
certain treatments still being evaluated in late-stage trials
available to patients for whom no satisfactory alternatives are
available. To grant expanded access, the FDA generally must be
satisfied that the potential benefit for the patient justifies the
potential risk. Delcath recently announced that sufficient patient
events had occurred in its randomized, multi-center Phase III trial
of melphalan for data analysis to begin. Under the Expanded Access
Program, the five centers treating the highest number of patients
during the Phase III trial may continue to treat patients with
metastatic melanoma to the liver while the data is being evaluated.
The Expanded Access Program allows patients to be enrolled into the
non-randomized study, materially identical to the melphalan arm of
the randomized Phase III trial that will be submitted to FDA for a
New Drug Application ("NDA") review. Patients treated under the
Expanded Access Program will not be included in the data analysis
currently underway. Delcath is currently in the final stages of
negotiating research contracts with the individual institutions and
achieving Institutional Review Board ("IRB") approvals at these
five centers. The Company may in the future petition the FDA to add
additional centers. "The Expanded Access Program is terrific news,"
said Eamonn P. Hobbs, President and CEO of Delcath. "It allows us
to offer help to patients with metastatic melanoma to the liver who
have no other options at this stage of their disease. And as it is
based on available evidence, this development underscores our
confidence in the efficacy of high-dose melphalan combined with the
Delcath PHP System for this unmet medical need." Delcath's Phase
III trial completed enrollment of 93 patients in October 2009 and
the 73rd event required under the study's Special Protocol
Assessment prior to the initiation of patient data analysis, was
reported on February 4, 2010. The trial's data analysis has begun
and involves the initial review by the trial's principal clinical
investigators at each of the enrolling centers, additional review
by the Company's retained Clinical Research Organization, and then
a final review by an independent core lab for verification of
results before final statistical results can be attained. Given
recently updated schedules by the external reviewers, the
completion of this comprehensive review process is now expected to
be in April and the Company plans to promptly release key elements
as they become available. Submission of the NDA package to the FDA
for marketing approval will be made as soon as practically
possible, once the data analysis process is completed. "Our goal is
to make sure that all data from the trial is thoroughly reviewed
before any release and we fully support the comprehensive process
underway. We remain highly confident that the trial's data will
meet the trial's primary endpoint, and our confidence has been
further buoyed by the FDA's acknowledgement of an expanded access
program," Mr. Hobbs concluded. About Delcath Systems, Inc. Delcath
Systems, Inc. is a medical technology company specializing in
cancer treatment. The Company is testing a proprietary, patented
drug delivery system for the treatment of primary and metastatic
liver cancers. Delcath's novel drug delivery platform is testing
the delivery of ultra-high doses of anti-cancer agents to the liver
while controlling the systemic exposure of those agents. In
addition to the Phase III metastatic melanoma study, the Company is
currently conducting trials to treat other forms of tumor
metastases to the liver. The Company maintains a broad intellectual
property portfolio on a worldwide basis including the U.S., Europe,
Asia and Canada. For more information, please visit the Company's
website at http://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.
DATASOURCE: Delcath Systems, Inc. CONTACT: Investors, Doug Sherk,
or Barbara Domingo, both of EVC Group, +1-415-896-6820, for Delcath
Systems, Inc.; or Media, Steve DiMattia of EVC Group,
+1-646-201-5445, for Delcath Systems, Inc. Web Site:
http://www.delcath.com/
Copyright