Delcath Systems Granted Third Orphan Drug Designation
02 Juni 2009 - 2:00PM
PR Newswire (US)
NEW YORK, June 2 /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 the United States Food and Drug
Administration ("FDA") granted Delcath's application for
orphan-drug designation for the drug melphalan for the treatment of
patients with neuroendocrine tumors. (Logo:
http://www.newscom.com/cgi-bin/prnh/20081118/NY46990LOGO) Delcath
is enrolling patients in a Phase II clinical trial testing its
proprietary drug delivery system, known as the Delcath Percutaneous
Hepatic Perfusion ("PHP") System(TM), with ultra-high doses of the
drug melphalan for the treatment of neuroendocrine tumors
metastatic to the liver. The trial is treating patients with
pancreatic islet-cell and carcinoid tumors at the National Cancer
Institute in Bethesda, Maryland. Commenting on this orphan-drug
designation, Richard L. Taney, President and CEO of Delcath,
stated, "We are pleased that the FDA has granted the Company
another orphan drug designation. This FDA decision follows two
previously granted Delcath orphan drug designations for the drug
melphalan for the treatment of patients with metastatic cutaneous
melanoma and metastatic ocular melanoma. High dose melphalan, for
the treatment of neuroendocrine tumors, is an indication that we
have aggressively targeted in our Phase II multi-histology trial.
These designations, along with our patents and clinical milestones,
are important steps in our efforts to secure Delcath's commercial
position upon conclusion of our clinical programs." Orphan drug
designation, when granted by the FDA's Office of Orphan Products
Development, allows for up to seven years of marketing exclusivity
after gaining 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-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.
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 ; Robin Wagge, Public Relations Contact of Rubenstein
Associates, Inc., +1-212-843-8006, or , for Delcath Systems, Inc.
Web Site: http://www.delcath.com/
Copyright