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DELCATH SYSTEMS, INC.
(Name of Registrant as Specified In Its Charter)
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Company Contact: Investor Contacts:
Delcath Systems, Inc. Todd Fromer / Garth Russell
M. S. Koly, Chief Executive Officer KCSA Worldwide
203-323-8668 (212) 896-1215 / (212) 896-1250
www.delcath.com tfromer@kcsa.com / grussell@kcsa.com
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Media Contact:
Lewis Goldberg
KCSA Worldwide
(212) 896-1216
lgoldberg@kcsa.com
FOR IMMEDIATE RELEASE
Delcath Systems Announces a New Site for the Phase III Doxorubicin
Clinical Trial in placeCitySan Antonio, StateTX
- - -
Rohit Kapoor, M.D. Named the Principal Investigator for Study
STAMFORD, Conn., August 18, 2006 -- 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. placeStateTexas 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 placecountry-regionU.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 country-regionUnited States, Europe, Asia and
placecountry-regionCanada. For more information, please visit the Company's
website, www.delcath.com.
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 www.sec.gov. 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).
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