Enrollment in Delcath's Pivotal Phase III Metastatic Melanoma Clinical Trial Reaches Halfway Point
11 Dezember 2008 - 2:00PM
PR Newswire (US)
NEW YORK, Dec. 11 /PRNewswire-FirstCall/ -- Delcath Systems, Inc.
(NASDAQ: DCTH), a medical technology company testing its
proprietary Percutaneous Hepatic Perfusion ("PHP") System for the
treatment of cancers of the liver, announced today that the first
fifty percent (46 of 92) of patients have been enrolled in the
Phase III clinical trial treating metastatic cutaneous and ocular
melanoma to the liver. The eleven participating cancer centers in
this trial continue to evaluate and enroll patients and the Company
looks forward to completing enrollment in 2009. (Logo:
http://www.newscom.com/cgi-bin/prnh/20081118/NY46990LOGO )
Commenting on this important event, Richard L. Taney, President and
Chief Executive Officer of Delcath, stated, "Enrollment of the
forty-sixth patient in this trial represents a significant
milestone for our Company as we continue to accelerate this trial
and accrue the data to support FDA approval of the Delcath PHP
System. Attaining the midpoint of this trial, on the heels of
expanding to eleven centers, is an important confirmation that the
Company remains on the clinical and regulatory schedule discussed
with investors over the past six months. The clinical data for the
first 46 patients will be submitted to the Data Safety Monitoring
Board for evaluation, once we complete the collection of follow-up
data on the recently treated patients. We look forward to updating
our investors during our upcoming conference call to be held next
month." This multi-center clinical study is being conducted under a
Cooperative Research and Development Agreement (CRADA) with the
National Cancer Institute (NCI). Under this CRADA, patients for
this study are being treated at the NCI and at ten cancer centers
throughout the United States. The NCI is serving as coordinating
center for the study, which includes the initiation and training of
the new clinical trial centers for this important trial. Plans
under the CRADA include continuing patient enrollments and
completing the clinical testing of PHP as treatment for these life
threatening liver diseases. The Phase III Study The Phase III study
is testing Delcath's PHP System 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 System is designed to deliver significantly higher doses of
anti-cancer drugs to a patient's liver while preventing entry of
the drugs to the rest of the patient's circulation. This isolation
limits toxicities that result from systemic chemotherapy
treatments. Patients in the Phase III trial initially are
randomized into one of two treatment arms, including immediate
treatment with melphalan via the Delcath System 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), when disease progresses in
patients enrolled in the best alternative care arm of the trial,
they are permitted to "cross over" and receive treatment with the
Delcath System. 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/NY46990LOGODATASOURCE:
Delcath Systems, Inc. CONTACT: Richard Taney of Delcath Systems,
Inc., +1-212 489-2100, ; or Robin Wagge of Rubenstein Associates,
Inc., +1-212-843-8006, , for Delcath Systems, Inc. Web Site:
http://www.delcath.com/
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