-- The submission to the Food and Drug Administration of a proposed Phase
III trial protocol for the treatment of metastatic neuroendocrine tumors in
the liver
-- The planned submission of a Phase III trial protocol comparing the
delivery of high dose Doxorubicin with the Delcath Percutaneous Hepatic
Perfusion (PHP) System versus Nexavar® (sorafenib) for the treatment of
primary liver cancer (HCC)
-- The planned application to China's regulatory authority, the SFDA, for
an import license for the Delcath PHP System in China
-- The planned application for issuance of a CE Mark for the Delcath PHP
System in Europe
Mr. Taney commented, "We are very proud of the progress Delcath has made
and are excited about the current positioning of our technology platform.
PHP holds great promise to be a major innovation in the fight against
cancers of the liver and we are working diligently with our clinical
partners to complete our current Phase III trial treating patients with
inoperable melanoma and to seek regulatory approval. We look forward to
providing continued updates to our shareholders on the progress of our
various initiatives over the balance of the year."
Further information on this announcement and a copy of the information
presented at the Annual Meeting of Shareholders can be found in our
regulatory filings under Form 8-K.
About Delcath Systems, Inc.
Delcath Systems is a developmental stage company testing its percutaneous
perfusion technology for the isolated delivery of high doses of therapeutic
and chemotherapeutic agents. The Delcath System is currently being tested
with the drug melphalan in Phase III and Phase II clinical trials. The
Company's intellectual property portfolio currently 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
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.
Contact Information: Company Contact: Delcath Systems, Inc. Richard Taney (212) 489-2100 www.delcath.com Media Relations Contact: The Global Consulting Group Ivette Almeida Investor Relations Contact: Strategic Growth International, Inc. Richard E. Cooper (212) 838-1444