Delcath Systems, Inc. Completes Phase III Study Enrollment

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Wed Oct 21, 2009 6:30am EDT

NEW YORK, Oct. 21 /PRNewswire-FirstCall/ -- Delcath Systems, Inc. (Nasdaq:
DCTH), a medical technology company testing its proprietary treatment method
for primary and metastatic cancers to the liver, announced today that its
pivotal Phase III Metastatic Melanoma Trial has met its goal of 92 patients
and is fully enrolled. This clinical study is evaluating the Delcath PHP
System(TM) for the regional delivery of melphalan to the liver to treat
patients with metastatic cutaneous and ocular melanoma who have unresectable
tumors in the liver. 


With the achievement of complete enrollment, the company remains on-track for
a FDA submission of its Delcath PHP System(TM) with melphalan in 2010.  Trial
enrollment will continue for the near-term to include additional patients that
have begun the evaluation process and may be eligible to participate.  


"We always expected to see the greatest enrollment activity in the second half
of the study period as positive word about the Delcath PHP System spread and
attracted new patients to the study," said Eamonn Hobbs, President and CEO of
Delcath Systems.  "We are delighted to have completed enrollment on-plan, and
to continue the extremely positive momentum created over the last six months. 
We have achieved several key, strategic milestones, including the successful
review of our Phase III safety data, orphan drug designation for doxorubicin
for the treatment of hepatocellular carcinoma, and the additions of David
McDonald as Chief Financial Officer and Dr. Krishna Kandarpa as Chief Medical
Officer and EVP of Research and Development. We also executed on our plans to
build our own manufacturing facility, which we will continue to develop as we
focus for the remainder of the year on preparation for our FDA submission,
commercialization and international licensing."


About the Phase III Study
This clinical study is testing the Delcath PHP System(TM) for the regional
delivery of melphalan to the liver to treat patients with metastatic cutaneous
and ocular melanoma who have unresectable tumors in the liver. The Delcath PHP
System(TM) is designed to deliver significantly higher doses of anti-cancer
drugs to a patient's liver while minimizing entry of the drugs into the rest
of the patient's circulation. This isolation limits toxicities which result
from systemic chemotherapy treatments.


Patients in the Phase III trial are randomized into one of two treatment arms,
including immediate treatment with melphalan via the Delcath PHP System(TM) 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 under a Special Protocol
Assessment (SPA), patients are permitted to "cross-over" from the best
alternative care arm to receive treatment with the Delcath System at the time
of disease progression.


About Delcath Systems, Inc.
Delcath Systems, Inc. is a medical device company specializing in cancer
treatment. The Company is testing a proprietary, patented drug delivery system
for the treatment of liver cancers. Delcath's novel drug delivery platform is
testing the delivery of ultra-high doses of anti-cancer drugs to the liver
while preventing these high doses of drug from entering the patient's
bloodstream. 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 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.






SOURCE  Delcath Systems, Inc.

Investor, Doug Sherk, Stacey Fisher, or Mike Pollack, +1-415-896-6820; or
Media, Steve DiMattia, +1-646-201-5445, all of EVC Group, for Delcath Systems,
Inc.
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