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:10/4/2017)... , Oct. 4, 2017  South Korean-based healthcare product ... training aide "cprCUBE" on Kickstarter. The device will educate ... cardiac arrests with better efficiency compared to the dated ... real-time feedback on efficacy of the compression for a ... has a goal to raise $5,000. ...
(Date:10/2/2017)... , Oct. 2, 2017  AllianceRx Walgreens Prime, ... formed by Walgreens and pharmacy benefit manager Prime Therapeutics ... new brand, which included the unveiling of new signage ... , as well as at a few other company-owned ... new brand to patients, some of whom will begin ...
(Date:9/27/2017)...  Commended for their devotion to personalized service, SMP Pharmacy ... one in the South Florida Business Journal,s 50 Fastest-Growing Companies, ... list, the national specialty pharmacy has found its niche.  To ... soon be honored by SFBJ as the 2017 Power Leader ... to receive his award in October, Bardisa said of the ...
Breaking Medicine Technology:
(Date:10/13/2017)... York, NY (PRWEB) , ... October 13, 2017 , ... ... influential people in business to advocate for action towards gender equality at their inaugural ... views from around the globe, and reached a social audience of over 3 million. ...
(Date:10/13/2017)... ... October 13, 2017 , ... “The Journey: From the Mountains ... possible to save lost souls in the Philippines. “The Journey: From the Mountains to ... dedicated teacher of the Bible. She has taught all ages and currently teaches a ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... the demand of today’s consumer and regulatory authorities worldwide. From Children’s to Adults ... tested to meet the highest standard. , These products are also: Gluten ...
(Date:10/12/2017)... ... October 12, 2017 , ... Dr. Parsa Mohebi, the ... medical article to the newly revamped Cosmetic Town journal section, featuring ... transplant procedure known as Follicular Unit Extraction (FUE). , Dr. Mohebi ...
(Date:10/12/2017)... ... October 12, 2017 , ... Health Literacy ... health literacy software tool, and the Cancer Patient Education Network (CPEN), an independent ... today announce a new strategic alliance. , As CPEN’s strategic partner, HLI ...
Breaking Medicine News(10 mins):