FDA Grants Delcath Orphan-Drug Designation for Doxorubicin
August 31 2009 - 5:30AM
PR Newswire (US)
NEW YORK, Aug. 31 /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 that the U.S. Food & Drug Administration
granted Delcath's request for orphan drug designation for
doxorubicin for the treatment of hepatocellular carcinoma (HCC),
also known as primary liver cancer. Clinicians in the U.S. diagnose
nearly 20,000 cases of HCC annually. Doxorubicin is a common
chemotherapy agent shown to be effective for the treatment of HCC,
as well as hematological malignancies, soft tissue sarcomas, and
many types of carcinoma. Delcath Systems performed early clinical
studies of doxorubicin with its Percutaneous Hepatic Perfusion
(PHP(TM)) technology, which allows physicians to deliver
significantly higher doses of anti-cancer drugs to the liver
without exposing the patient's entire body to those same potent
levels of drug, with very encouraging results. The company plans to
perform the clinical work necessary for a submission to the FDA of
PHP(TM) with doxorubicin for treatment of HCC. "Following our
orphan-drug designations for several applications of melphalan,
this new designation for doxorubicin is an important step towards
securing our leadership position in the regional treatment of liver
cancers," said Eamonn Hobbs, President and CEO of Delcath Systems.
"Patients with HCC have few good options. Doxorubicin has an
established track record as a treatment for several cancers,
including HCC. We believe that Delcath's Percutaneous Hepatic
Perfusion(TM) System can deliver high-dose doxorubicin to the liver
and spare the patient from systemic exposure, thereby creating a
new, tolerable and effective treatment option for these patients.
It is our plan to aggressively pursue this indication with the
required clinical work." 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 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, all
of EVC Group, +1-415-896-6820, for Delcath Systems, Inc., Media,
Steve DiMattia of EVC Group, +1-646-201-5445, for Delcath Systems,
Inc. Web Site: http://www.delcath.com/
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