Navigation Links
Delcath Expands Phase III Trial for Metastatic Melanoma to Include St. Luke's Cancer Center

NEW YORK, June 3 /PRNewswire-FirstCall/ -- Delcath Systems, Inc. (Nasdaq: DCTH) announced today that the St. Luke's Cancer Center of Bethlehem, PA, part of St. Luke's Hospital & Health Network (St. Luke's), has joined Delcath's Phase III clinical trial for the treatment of inoperable metastatic melanoma in the liver using the Company's Percutaneous Hepatic Perfusion (PHP) System for the isolated, high dose delivery of the anti-cancer agent melphalan. This Phase III multi-center study is led by the National Cancer Institute (NCI) and is enrolling at cancer centers throughout the United States.

Delcath has finalized a clinical research agreement with St. Luke's. Sanjiv Agarwala, M.D., Chief of Oncology and Hematology, will serve as the Principal Investigator of the study at St. Luke's. Dr. Agarwala, a leader in the field of melanoma and clinical oncology, commented, "Metastatic melanoma in the liver presents a devastating cancer with no effective treatment options. We are very pleased to be able to provide this option to patients suffering from this disease. This is a study with tremendous potential to treat patients with aggressive disease burden and is a promising advance in the field of liver directed regional therapy."

"The addition of St. Luke's and Dr. Agarwala to this trial, which follows the recent announcement that the University of Maryland will commence enrollment of patients, is expected to be followed by the announcement of additional centers during the summer. Delcath continues to expand this Phase III study to leading cancer centers and we welcome this collaboration with St. Luke's, as it further allows the Delcath PHP System to reach patients who can benefit from this treatment option," said Richard L. Taney, President and CEO of Delcath Systems. "We plan to continue expanding this trial to centers throughout the United States and broadening the availability of the technology."

The Phase III Study

The Phase III study is designed to test Delcath's proprietary PHP System for the regional delivery of melphalan to the liver to treat patients with metastatic ocular and cutaneous melanoma who have unresectable tumors in the liver. The Delcath PHP System is designed to deliver significantly higher doses of anti-cancer drugs to a patient's liver while preventing entry of the drugs to the rest of the patient's circulation. This isolation limits toxicities that result from systemic chemotherapy treatments.

Patients in the Phase III trial initially are randomized into one of two treatment arms, including immediate treatment with melphalan via the Delcath PHP System or treatment with best alternative care. The study is designed to evaluate the duration of tumor response in each of the two study arms. Following guidelines established by U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA), when disease progresses in patients enrolled in the best alternative care arm of the trial, they are permitted to "cross over" and receive treatment with the Delcath PHP System. The Phase III study, which recently exceeded 33% enrollment, is expected to be completed in 2009, leading to an application to the US Food and Drug Administration (FDA) for commercial approval of the Delcath PHP System.

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 PHP 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

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.

Company Contact:

Delcath Systems, Inc.

Richard Taney

(212) 489-2100

Media Relations Contact:

The Global Consulting Group

Ivette Almeida

(646) 284-9455

Investor Relations Contact:

Strategic Growth International, Inc.

Richard E. Cooper

(212) 838-1444

SOURCE Delcath Systems, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Delcath Updates Phase III Patient Enrollment as Pivotal Trial Accelerates, Durable Tumor Responses In Phase II Study Also Cited
2. Delcath Expands Phase III Trial for Metastatic Melanoma to Include University of Maryland Medical Center
3. BiPar Sciences Expands Clinical Development of BSI-201, A Novel PARP Inhibitor, With Phase 2 Trial in Uterine Cancer
4. BiPar Sciences Expands Phase 2 Clinical Trials of BSI-201, a Novel DNA Repair Inhibitor, in Ovarian Cancer
5. CoreSpine Technologies Expands Spinal Disc Site Preparation Efforts
6. Alseres Pharmaceuticals Expands Sites for the First Stage of the ALTROPANE(R) Phase III Clinical Trial Program
7. Senesco Expands on Recently Announced Preclinical Pancreatic Islet Data
8. BiPar Sciences Expands Clinical Program for BSI-201, a Novel DNA Repair Inhibitor, in Brain Cancer
9. PAREXEL Expands Global Clinical Pharmacology Capabilities
10. Millennium Expands VELCADE(R) (Bortezomib) For Injection Program In Non-Hodgkins Lymphoma
11. PAREXEL Expands Late Phase Clinical Research Services and Appoints Leading Pharmacoepidemiology Expert Victor Kiri
Post Your Comments:
(Date:11/24/2015)... 24. November 2015 Avery Biomedical ... Systems, ist erfreut, die Berufung von Anders ... geben zu können. ... --> Foto -   ... Von 1984-1986 war er Fellow des Cardiovascular ...
(Date:11/24/2015)... India , November 24, 2015 ... market research report "Spine Biologics Market by Product Type (Bone ... (Anterior Cervical Discectomy and Fusion, Posterior Lumbar Interbody Fusion), End ... MarketsandMarkets, the global market was valued at $1.90 Billion in ... at a CAGR of 4.4% during the forecast period of ...
(Date:11/24/2015)... Nov. 24, 2015 Avery Biomedical Devices (ABD), ... to announce the appointment of Anders Jonzon , ... Dr. Jonzon is a ... Children,s Hospital, Uppsala University, Uppsala and Children,s Hospital, Karolinska, ... was a fellow at the Cardiovascular Institute (UCSF). His ...
Breaking Medicine Technology:
(Date:11/24/2015)... ... November 24, 2015 , ... Preparing for the LDT ... 3:00 p.m. EST, , FDA has long asserted that design and ... to performing the tests and do not meet the device regulations. , Come up ...
(Date:11/24/2015)... ... November 24, 2015 , ... ... pleased to welcome Winter-Dent & Company as its newest Partner Firm. Based in ... become a client's most trusted advisor regardless of whether that client is a ...
(Date:11/24/2015)... ... ... With Thanksgiving right around the corner, holiday travel season is about to begin. ... vehicle. , According to the National Highway Traffic Safety Administration, 301 people were killed ... safety tips from the NHTSA: , Inspect tires ...
(Date:11/24/2015)... IL (PRWEB) , ... November 24, 2015 , ... Dr. Rodney E. Willey , ... His new venture, Koala Center for Sleep Disorders, provides treatment for snoring and sleep ... who have opened a Koala Center for Sleep Disorders in the US, one of four ...
(Date:11/24/2015)... (PRWEB) , ... November 24, 2015 , ... Dr. Kevin ... office to help the community stress less this holiday season. During the Indiana ... stress in people's lives and the team at AlignLife want to help provide the ...
Breaking Medicine News(10 mins):