Delcath Systems, Inc. Announces Patient Recruitment Exceeds 90%
25 August 2009 - 12:30PM
PR Newswire (US)
NEW YORK, Aug. 25 /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 it has exceeded 90% enrollment
reaching 85 patients for its pivotal Phase III Metastatic Melanoma
Trial. Based on trial specifications, the Company needs 92 for
enrollment achievement. "We are pleased to report this important
patient enrollment milestone. Our success validates the need for a
drug delivery platform that is unique in the interventional
oncology arena. With approximately 250,000 cases of primary or
secondary cancer of the liver diagnosed each year in the U.S. and
2.6 million cases globally, we believe our Percutaneous Hepatic
Perfusion (PHP(TM)) technology is a compelling proposition," said
Eamonn Hobbs, President and CEO of Delcath Systems. "Our next
milestone will be a successful review of safety data in early
September in preparation for a FDA submission by mid-2010, as well
as CE Mark approval, which would allow for marketing outside the
U.S.A. by June 2010." 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 is currently enrolling patients
in Phase III and Phase II clinical studies for the treatment of
liver cancers using high doses of melphalan. The Company's
intellectual property portfolio consists of twenty-seven patents 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, 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/
Copyright