Navigation Links
Delcath Systems Begins Data Analysis of Phase III Trial
Date:2/4/2010

NEW YORK, Feb. 4 /PRNewswire-FirstCall/ -- Delcath Systems, Inc. (Nasdaq: DCTH), a medical technology company testing its proprietary treatment system for metastatic cancers to the liver, announced today that sufficient events have been reached to allow data analysis to begin on its Phase III trial.  The trial uses the drug melphalan to treat patients with metastatic melanoma in the liver.  

"We remain very optimistic that the Phase III trial will achieve a successful endpoint," said Eamonn P. Hobbs, President and CEO of Delcath. "Assuming a successful trial endpoint, we remain committed to filing our NDA with the FDA in April," Mr. Hobbs added.

The 92 patient, randomized, multi-center, Phase III study commenced patient enrollment in February 2006.  Patients were randomly assigned to receive treatments with ultra-high doses of the chemotherapeutic drug melphalan infused directly into the liver via the Delcath PHP System™ or to a control group, where they were provided with best alternative care (BAC).  BAC included alternative regional or systemic therapies.  Patients assigned to the Delcath arm were eligible to receive up to six cycles of treatment at approximately four to six week intervals.  Patients randomized to the non-PHP arm were permitted to cross-over into the Delcath arm at documentation of hepatic disease progression.

The study's primary objective was to demonstrate a statistically significant improvement in the hepatic progression free survival (HPFS) of patients with metastatic melanoma (ocular or cutaneous) to the liver treated with the Delcath PHP System™ versus patients in the control arm. Secondary endpoints include response rate, duration of response and overall survival.

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 primary and metastatic 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.  In addition to the Phase III metastatic melanoma study, the Company is currently conducting trials to treat other forms of tumor metastases to the liver. 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 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 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.

SOURCE Delcath Systems, Inc.

RELATED LINKS
http://www.delcath.com

'/>"/>

SOURCE Delcath Systems, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Delcath Systems, Inc. to Present at the 12th Annual Needham Growth Stock Conference
2. Professor Riccardo Lencioni Joins Delcath Systems Scientific Advisory Board
3. Delcath Systems Reports Substantial Progress
4. Delcath Systems Announces Completion of Public Offering
5. Delcath Systems, Inc. Prices $30.6 Million Stock Offering
6. Delcath Systems, Inc. Completes Phase III Study Enrollment
7. Delcath Systems, Inc. Appoints Dr. Krishna Kandarpa its Executive Vice President R&D and Chief Medical Officer
8. Data Safety Monitoring Board Unanimously Recommends Continuation of Delcaths Phase III Clinical Trial
9. Enrollment in Delcaths Pivotal Phase III Metastatic Melanoma Clinical Trial Achieves Seventy-Five Percent Accrual
10. Delcath Continues Expansion of Clinical Trial Centers Offering PHP(TM)
11. Delcath Adds Dr. Pamela R. Contag to Its Board of Directors
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/20/2017)... 19, 2017  Hill-Rom Holdings, Inc. (NYSE: HRC), will host ... on Friday, July 28, 2017, beginning at 7:30 a.m. (CDT) ... Dial-in information: To participate in the conference call, dial (877) ... call at least 10 minutes prior to the start to ... Webcast: A simultaneous webcast ...
(Date:6/14/2017)... 14, 2017  ivWatch LLC, a medical device company ... (IV) therapy, is pleased to announce it was the ... Hospital Supplies and Equipment at the 2017 Medical Design ... medtech industry. The award was presented by Medical Device ... Center in New York during ...
(Date:6/12/2017)... June 12, 2017 Kineta, Inc., a biotechnology company ... Kineta Vice President of R&D and Head of Virology ... Pandemic Preparedness for the Northwest and Beyond meeting sponsored ... June 14, 2017 from 8:30-10:30 AM PDT at the Agora ... Dr. Bedard will be joined by other leaders ...
Breaking Medicine Technology:
(Date:6/24/2017)... ... June 24, 2017 , ... Genes Advice, a ... in select Florida and Texas doctors' offices and clinics. This breakthrough testing is ... genetic testing recognizes the role genes play in determining an individual's tolerance of ...
(Date:6/24/2017)... ... , ... Doorknobs are for convenience, deadbolts are for security. , There are ... having an alarm system installed. But unless there is a working deadbolt lock that ... TX Premier Locksmith in Killeen, TX says: “In the majority of home burglaries, intruders ...
(Date:6/23/2017)... MA (PRWEB) , ... June 23, 2017 , ... ... Care Reconciliation Act (BCRA), their proposed healthcare bill to repeal and replace the ... May, the Senate bill would make significant cuts to Medicaid, a public health ...
(Date:6/23/2017)... ... June 23, 2017 , ... Military Connection friend and veteran advocate ... JFK Virgin Atlantic lounge. , Bensko is no stranger to the plight of ... dedicated her life to supporting our wounded veterans. A world-class photographer, her riveting photos ...
(Date:6/23/2017)... ... June 23, 2017 , ... Ensuring meat ... new videos highlight the importance of correctly using a meat thermometer. The videos ... done extensive research on consumer food safety habits. Dr. Bruhn explains the variety ...
Breaking Medicine News(10 mins):