Delcath Systems Granted Orphan-Drug Designations for Cutaneous and Ocular Melanoma
18 November 2008 - 2:00PM
PR Newswire (US)
NEW YORK, Nov. 18 /PRNewswire-FirstCall/ -- Delcath Systems, Inc.
(NASDAQ: DCTH), a medical technology company testing its
proprietary liver cancer treatment for melanoma metastatic to the
liver, announced today that the United States Food and Drug
Administration ("FDA") granted to Delcath two orphan-drug
applications for the drug melphalan. Delcath was granted
designations of the drug melphalan for the treatment of patients
with cutaneous as well as ocular melanoma. Approximately 65,000
cases of these melanomas are diagnosed annually in the United
States. (Logo:
http://www.newscom.com/cgi-bin/prnh/20081118/NY46990LOGO) Delcath
is actively enrolling patients in a Phase III clinical trial
testing its proprietary drug delivery system, known as Percutaneous
Hepatic Perfusion ("PHP"), with melphalan for the treatment of
ocular and cutaneous melanoma metastatic to the liver. This NCI-led
trial is enrolling patients at leading cancer centers throughout
the United States. Commenting on these orphan-drug designations,
Richard L. Taney, President and CEO of Delcath, stated, "These
favorable designations are important steps in our efforts to secure
Delcath's commercial position upon conclusion of our pivotal Phase
III trial for metastatic melanoma. We remain steadfast in our
commitment to become the leader in the regional treatment of liver
cancers and we continue to enroll patients in this study, and
advance our technology and the promise that it offers to patients
with these deadly forms of melanoma and other cancers of the liver,
all with limited treatment options." Orphan drug designation, when
granted by the FDA's Office of Orphan Products Development, allows
for up to seven years of market exclusivity upon FDA approval, as
well as clinical study incentives, study design assistance, waivers
of certain FDA user fees, and potential tax credits. 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
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-eight 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.
http://www.newscom.com/cgi-bin/prnh/20081118/NY46990LOGO
http://photoarchive.ap.org/ DATASOURCE: Delcath Systems, Inc.
CONTACT: Richard Taney of Delcath Systems, Inc., +1-212-489-2100, ;
or Investor Relations Contact: Richard E. Cooper of Strategic
Growth International, Inc., +1-212-838-1444, ; or Public Relations
Contact: Robin Wagge of Rubenstein Associates, Inc.,
+1-212-843-8006, Web Site: http://www.delcath.com/
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