Delcath Systems,
Inc. (Nasdaq: DCTH) ("Company") announced today that the Methodist Health
Care System ("Site") has joined Delcath's Phase III clinical trial for the
treatment of metastatic melanoma that has spread to the liver, using the
Delcath system with Doxorubicin, an approved anti-cancer agent.
The Site, located in San Antonio, TX, has named Dr. Rohit Kapoor, M.D.
as the principal investigator to oversee the trial. In addition to the
Site's main facility the agreement names The Cancer Center of San Antonio
and LabCorp, also of San Antonio, as additional locations participating in
recruitment and treatment of patients. The Company has already received the
Site's Institutional Review Board (IRB) and budgeting approvals. Delcath
has reserved the right to terminate the agreement if the first patient is
not enrolled within 90 days, or if two additional patients are not enrolled
within five months of the first patient. The Company has notified the U.S.
Food and Drug Administration (FDA) about the participation of this Site in
the Phase III Doxorubicin trial, which is one of the sites of the 15
permitted to be enrolled in the trial.
The protocol for the Phase III Doxorubicin trial received U.S. FDA
approval in 2004. The randomized, multi-center clinical trial will enroll
patients diagnosed with metastatic melanoma in the liver. The Company will
be looking to demonstrate results that show patients treated with the
Delcath system experience statistically longer survival rates versus the
control group.
The Methodist Hospital Research Institute has an established history of
conducting groundbreaking clinical research and is committed to the
advancement of new therapies as rapidly as possible. Texas has a sizable
population of melanoma patients from which to draw upon, providing an ideal
proving ground for treatment using the Delcath system with Doxorubicin.
"We are pleased to announce the Methodist Health Care System and its
affiliated locations as the first U.S. sight for our Phase III Doxorubicin
trial. This marks an important milestone for this trial as recruitment is
resumed under the guidance of such a highly esteemed U.S. establishment as
Methodist Health Care System. Also, we are very happy that the Doxorubicin
trial will be taking place in a different geographical location than our
Phase III Melphalan trial, which we believe will increase word-of-mouth,
and create greater awareness of the Delcath system," said M.S. Koly,
president and chief executive officer of Delcath Systems. "This
announcement is further evidence of management's unwavering commitment and
ability to recruit sites for the Doxorubicin trial in the U.S. and execute
upon its stated business plan. This is a great boost to our efforts and we
will continue to recruit new sites for both the Phase III Doxorubicin and
Phase III Melphalan trials."
About Delcath Systems, Inc.
Delcath Systems is a developer of isolated perfusion technology for
organ or region-specific delivery of therapeutic agents. The Company's
intellectual property portfolio currently consists of 12 patents on a
worldwide basis, including the United States, Europe, Asia and Canada. For
more information, please visit the Company's website, delcath.
This 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.
Delcath undertakes no obligation to publicly update or revise these
forward-looking statements to reflect events or circumstances after the
date they are made.
On August 1, 2006, Laddcap filed a preliminary consent solicitation
statement with the SEC relating to Laddcap's proposal to, among other
things, remove the current Board of Directors and replace them with
Laddcap's nominees. In response, on August 7, 2006, Delcath filed a
preliminary consent revocation statement on Form PREC14A with the SEC (the
"Preliminary Consent Revocation Statement") in opposition to Laddcap's
consent solicitation. Delcath shareholders should read the Preliminary
Consent Revocation Statement (including any amendments or supplements
thereto) because it contains additional information important to the
shareholders' interests in Laddcap's consent solicitation.
The Preliminary Consent Revocation Statement, the definitive consent
revocation materials (when filed) and other public filings made by Delcath
with the SEC are available free of charge at the SEC's website at
sec. Delcath also will provide a copy of these materials free of
charge upon request to Delcath Systems, Inc., Attention: M. S. Koly, Chief
Executive Officer, (203) 323-8668.
Delcath has engaged MacKenzie Partners, Inc., who may be deemed to be a
participant in the solicitation of Delcath shareholders, to assist in
connection with Delcath's communications with shareholders regarding
Laddcap's consent solicitation. Information regarding the interests of
MacKenzie Partners, Inc. is contained in the Preliminary Consent Revocation
Statement (including any amendments or supplements thereto). In addition,
certain of Delcath's directors, officers and employees may be deemed to be
participants in the solicitation of Delcath's shareholders. Information
regarding the names and interests of these other persons is contained in
the Preliminary Consent Revocation Statement (including any amendments or
supplements thereto).
Delcath Systems, Inc.
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