Delcath Systems, Inc. Completes Phase III Study Enrollment
21 October 2009 - 9:30PM
PR Newswire (US)
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
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: 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. Web Site:
http://www.delcath.com/
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