Delcath Systems Begins Data Analysis of Phase III Trial
05 February 2010 - 2:11AM
PR Newswire (US)
Company On Track For April 2010 FDA Submission NEW YORK, Feb. 4
/PRNewswire-FirstCall/ -- Delcath Systems, Inc. (NASDAQ: DCTH), a
medical technology company testing its proprietary treatment system
for metastatic cancers to the liver, announced today that
sufficient events have been reached to allow data analysis to begin
on its Phase III trial. The trial uses the drug melphalan to treat
patients with metastatic melanoma in the liver. "We remain very
optimistic that the Phase III trial will achieve a successful
endpoint," said Eamonn P. Hobbs, President and CEO of Delcath.
"Assuming a successful trial endpoint, we remain committed to
filing our NDA with the FDA in April," Mr. Hobbs added. The 92
patient, randomized, multi-center, Phase III study commenced
patient enrollment in February 2006. Patients were randomly
assigned to receive treatments with ultra-high doses of the
chemotherapeutic drug melphalan infused directly into the liver via
the Delcath PHP System(TM) or to a control group, where they were
provided with best alternative care (BAC). BAC included alternative
regional or systemic therapies. Patients assigned to the Delcath
arm were eligible to receive up to six cycles of treatment at
approximately four to six week intervals. Patients randomized to
the non-PHP arm were permitted to cross-over into the Delcath arm
at documentation of hepatic disease progression. The study's
primary objective was to demonstrate a statistically significant
improvement in the hepatic progression free survival (HPFS) of
patients with metastatic melanoma (ocular or cutaneous) to the
liver treated with the Delcath PHP System(TM) versus patients in
the control arm. Secondary endpoints include response rate,
duration of response and overall survival. 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 primary and metastatic
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. 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: Media, Steve DiMattia,
+1-646-201-5445, or Investors, Doug Sherk, or Barbara Domingo,
+1-415-896-6820, all of EVC Group, for Delcath Systems, Inc. Web
Site: http://www.delcath.com/
Copyright