Delcath Systems Reports Substantial Progress
November 19 2009 - 5:30AM
PR Newswire (US)
Recent Follow-On Public Offering Provides Resources to Execute Plan
Active Negotiations with Potential International Partners
Continuing Phase III Study Enrollment Completed Executive
Management Team Completed NEW YORK, Nov. 19 /PRNewswire-FirstCall/
-- Delcath Systems, Inc. (NASDAQ: DCTH), a medical technology
company developing the Delcath Percutaneous Hepatic Perfusion
(PHP(TM)) System, a minimally invasive drug delivery platform for
the regional treatment of cancer metastatic to the liver, today
reported on the Company's recent progress. "Since we last
communicated with our shareholders in late July, our team has
achieved many significant milestones as we move into the first
regulatory reviews for our PHP System and strive towards European
commercialization in 2010," said Eamonn P. Hobbs, President &
CEO. "Our most recent accomplishment is yesterday's closing of our
common stock public offering, which raised more than $32.4 million
and significantly improves our balance sheet. The successful
offering met all of the key goals established by the Board of
Directors and provides our company with the resources required to
execute our regulatory approval and go-to-market strategies. We
attracted several leading and internationally known institutional
investors to the offering and we fully expect the transaction will
shortly lead to new sell-side analyst coverage of the company,"
added Mr. Hobbs. Other recent highlights include: -- Active
negotiations continue with several international entities to
provide exclusive geographic market rights for the PHP System. --
In early September, the Data and Safety Monitoring Board ("DSMB")
reviewed clinical data on 77 patients enrolled in Delcath's pivotal
Phase III clinical trial and unanimously recommended that the trial
continue to enroll patients with the goal of reaching the 92
patients required to complete the study. -- In October, the pivotal
Phase III Metastatic Melanoma Trial met its goal of 92 patients and
was fully enrolled. This clinical study is evaluating the Delcath
PHP System(TM) 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. -- Enrollment in the Phase
II clinical study of the Delcath PHP System with melphalan for
patients with inoperable liver metastases from neuroendocrine
tumors has now reached 25 patients. The trial is continuing to
enroll patients. The multi-arm trial is being conducted by the
National Cancer Institute ("NCI") in Bethesda, Maryland. The trial
is also enrolling patients suffering from primary liver cancer and
metastatic adenocarcinomas (including colorectal cancer) and
melanoma. The Company expects to update data from this study in the
coming months. -- Completed the expansion of the executive
management team with the additions of David McDonald, Chief
Financial Officer; Dr. Krishna Kandarpa, Chief Medical Officer and
Executive Vice President of Research and Development; Agustin Gago,
Executive Vice President for Global Sales and Marketing; John
Purpura as Executive Vice President for Regulatory Affairs and
Quality Assurance; and Armand "Chuck" Frigon as Vice President for
Operations. -- Established a low cost operations facility in
Queensbury, New York in which Delcath plans to locate manufacturing
of its PHP System. "With the enrollment in our Phase III clinical
study completed, we are now beginning to prepare our application to
the FDA for marketing approval," said Mr. Hobbs. "We continue to
expect that we will submit the application to the FDA by the end of
the first half of 2010. Meanwhile, we are optimistic about our
ability to gain CE mark approval in Europe in early 2010 and expect
to begin commercial sales in the European markets shortly
thereafter. With the proceeds from the offering boosting our cash
balance to more than $37 million, and the potential opportunity to
gain additional resources through international partnerships, we
are very well positioned to execute on our strategies, expand the
potential benefits of the PHP System to patients globally and build
increasing returns to our shareholders." 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 maintains a broad intellectual property
portfolio 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 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 or Stacey Fisher, +1-415-896-6820, or Media,
Steve DiMattia, +1-646-201-5445, all of EVC Group for Delcath
Systems, Inc. Web Site: http://www.delcath.com/
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