Contact Information: Company Contact: Delcath Systems, Inc. Richard Taney (212) 489-2100 Investor Relations Contact: Strategic Growth International, Inc. Richard E. Cooper Cass Almendral (212) 838-1444 Public Relations Contact: Rubenstein Associates, Inc. Robin Wagge (212) 843-8006
Investigator Presents on Delcath Systems Phase III Trial Experience
Experience Treating Unresectable Liver Metastases From Melanoma Presented at International Melanoma Meeting
| Source: Delcath Systems, Inc.
NEW YORK, NY--(Marketwire - October 6, 2008) - Delcath Systems, Inc. (NASDAQ : DCTH ) reported
that the Adjunct Principal Investigator for its Phase III clinical trial,
James Pingpank, Jr., MD, discussed interim results from its randomized
study of high-dose melphalan, delivered via the Company's Percutaneous
Hepatic Perfusion (PHP) system, in patients with inoperable liver
metastases from melanoma. Dr. Pingpank's presentation entitled "Targeted
Chemotherapy: Minimally Invasive Percutaneous Hepatic Perfusion" was made
on Saturday, October 4 at the "Perspectives in Melanoma XII" Meeting in The
Hague, The Netherlands.
During his presentation at this prestigious conference, Dr. Pingpank
stated: "The results that we have seen to date are tracking the response
rates that we observed in the phase I trial of patients treated for
metastatic melanoma in the liver with Percutaneous Hepatic Perfusion." Dr.
Pingpank also discussed early results from the melanoma arm of the
Company's Phase II trial, which is limited to patients who had previously
received surgical isolated regional delivery of melphalan. Dr. Pingpank
reported: "Of the five patients treated to date in the Phase II melanoma
trial, we have observed a 100% response rate. All of these are durable
partial responses."
Dr. Pingpank treated the largest number of patients in Delcath's Phase III
Trial while at the National Cancer Institute (NCI). This ongoing study was
recently expanded to include ten leading cancer centers throughout the
United States. The Phase III trial of 92 patients is comparing Progression
Free Survival (PFS) in patients treated with the Delcath PHP System to a
control arm receiving Best Available Care (BAC). Following completion of
the Phase I trial in 2003, the FDA granted Fast Track review status and
advanced the Phase I trial directly to the Phase III trial. The trial,
which is governed by a Special Protocol Assessment (SPA) with the FDA,
seeks to demonstrate responses in PHP patients of at least 7.8 months,
versus an expected response of four months or less in patients receiving
BAC.
About Delcath Systems, Inc.
Delcath Systems, Inc. is a medical technology company specializing in
cancer treatment. The Company has developed a proprietary, patented system
which will improve the efficacy of cancer treatment while reducing the
considerable, systemic side-effects of chemotherapy. Delcath's novel drug
delivery platform is capable of delivering anti-cancer drugs at very high
doses to a specific organ or region of the body 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 www.delcath.com.
This release contains express or implied forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995 that
are based on the current belief of management. These statements relate to,
among other things, the results to date of our phase III clinical trials as
described above. These statements are neither promises nor guarantees, but
are subject to a variety of risks and uncertainties, many of which are
beyond our control, and which could cause actual results to differ
materially from those contemplated in these forward-looking statements. In
particular, the risks and uncertainties include, among other things: risks
that any results of any trials to date are interim and may not be borne out
or supported by subsequent or final results or that any such trials may not
be fully completed as necessary; risks relating to our ability to further
advance the development of the our system in clinical trials; risks of any
failure to comply with regulations relating to our system, including FDA
requirements; risks of failure to obtain the financial resources to
complete development of our system; the risk that the FDA may interpret the
results of our studies differently from any interpretation we may have; the
risk that Dr. Pingpank's discussion as described above or elsewhere does
not necessarily represent the position of or any information on behalf of
Delcath, since he is not an employee, consultant or agent of or otherwise
authorized to speak on behalf of Delcath, and all of the other risks
discussed from time to time in our filings with the Securities and Exchange
Commission, including our most recent Annual Report on Form 10-K and
subsequent Quarterly Reports on Form 10-Q. 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.