Navigation Links
Delcath Systems Granted Third Orphan Drug Designation
Date:6/2/2009

NEW YORK, June 2 /PRNewswire-FirstCall/ -- Delcath Systems, Inc. (Nasdaq: DCTH), a medical technology company testing its proprietary treatment method for primary and metastatic cancers to the liver, announced today that the United States Food and Drug Administration ("FDA") granted Delcath's application for orphan-drug designation for the drug melphalan for the treatment of patients with neuroendocrine tumors.

(Logo: http://www.newscom.com/cgi-bin/prnh/20081118/NY46990LOGO)

Delcath is enrolling patients in a Phase II clinical trial testing its proprietary drug delivery system, known as the Delcath Percutaneous Hepatic Perfusion ("PHP") System(TM), with ultra-high doses of the drug melphalan for the treatment of neuroendocrine tumors metastatic to the liver. The trial is treating patients with pancreatic islet-cell and carcinoid tumors at the National Cancer Institute in Bethesda, Maryland. Commenting on this orphan-drug designation, Richard L. Taney, President and CEO of Delcath, stated, "We are pleased that the FDA has granted the Company another orphan drug designation. This FDA decision follows two previously granted Delcath orphan drug designations for the drug melphalan for the treatment of patients with metastatic cutaneous melanoma and metastatic ocular melanoma. High dose melphalan, for the treatment of neuroendocrine tumors, is an indication that we have aggressively targeted in our Phase II multi-histology trial. These designations, along with our patents and clinical milestones, are important steps in our efforts to secure Delcath's commercial position upon conclusion of our clinical programs."

Orphan drug designation, when granted by the FDA's Office of Orphan Products Development, allows for up to seven years of
'/>"/>

SOURCE Delcath Systems, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3

Related biology technology :

1. Delcath Adds University of Pittsburgh Medical Center to Phase III Trial
2. Jonathan Lewis, M.D., Ph.D. Steps Down From Delcath Systems Board of Directors
3. Delcath Adds Senior Pharmaceutical Professional to Its Board of Directors
4. Enrollment in Delcaths Pivotal Phase III Metastatic Melanoma Clinical Trial Reaches Halfway Point
5. Eric D. Whitman, MD to Present on the Delcath PHP System(TM) at the 7th World Congress on Melanoma
6. Ciphergen Biosystems Receives Noncompliance Letter From The Nasdaq Stock Market
7. Cepheid Enters Into Five-Year Agreement With Northrop Grumman for the Purchase of Anthrax Test Cartridges for Use in United States Postal Service Biohazard Detection Systems
8. BioMaxx Systems Inc. Signs Engagement Letter With Alcofuel Technologies for Provision of an Ethanol Micro-Refinery
9. Systems Medicine (SM), a Subsidiary of Cell Therapeutics, Inc. (CTI), Announces Execution of CRADA with NCI/NIH to Develop Potential Cancer Treatments Targeting the Insulin Growth Factor (IGF) Pathway
10. NxStage Medical Provides Update on Medisystems Acquisition
11. ICx Awarded $1.5 M Contract by Department of Homeland Security for Development of Next Generation Bio Aerosol Systems

Post Your Comments:
*Name:
*Comment:
*Email:
(Date:11/24/2009)... The New York investment bank KTA...NEU) has agreed an AU$6.7 mil convertible note pri... The private placement was arranged by KTA Capital.... , New York (PRWEB) Nove...nt bank KTA Capital, LLC ("KTA Capital")...
(Date:11/24/2009)..., CALGARY and BLENHEIM, Ontario, Nov. 24 /PRNews...ed today it is acquiring the assets of Hyland Seed...tario. The addition of Hyland Seeds will further e...the company anticipates the introduction of Smart...de Tolerant Trait Technology in corn in 2012. The ...
(Date:11/24/2009)... , ST. LOUIS, Nov. 24 /PRNewswire-FirstCall/ -...be presenting at the NASDAQ OMX conference on Tues...M US/CST. Interested parties may listen via live a...tp://inve s tor.sig m a a ldrich.com/ . Us...le. ,, About Sigma-Aldrich: Sigma-Aldrich...
(Date:11/24/2009)... , REYKJAVIK, Iceland, November ... (Nasdaq: DCGN ) today announced the approval of a...cy Court for the District of Delaware,(the "Bankru...etition for,relief under Chapter 11 of the United ..., The orders issued by the Bankruptcy Cou...
Breaking Biology Technology:KTA Capital Arranges an AU$6.7 Million Private Placement by Neuren Pharmaceuticals 2Dow AgroSciences Canada Announces Agreement to Acquire Hyland Seeds 2Dow AgroSciences Canada Announces Agreement to Acquire Hyland Seeds 3deCODE genetics, Inc. Announces Approval of First Day Motions by Bankruptcy Court 2deCODE genetics, Inc. Announces Approval of First Day Motions by Bankruptcy Court 3
...n-based Standard Networks announced Tuesday a ne...ing files and messages with its MOVEit DMZ servers...s. , ,MOVEit API Java will supplement the company,...a Windows API and a Perl API for Unix systems, as ...va offering is targeted at mainframe, Solaris, Lin...
...n-based SecurePipe, Inc. , a provider of managed-...lliance with META Security Group to deliver comb...of the GLBA and HIPAA regulations for financia...rate SecurePipe,s managed network security service...stems, e-mail management and virtual private netwo...
...sse, Wis. Firstlogic, Inc. announced Thursday i...er and distributor in compliance with the United ...s Linkage System, or NCOALink. , ,The latest versi...tified as an interface that meets the program,s re...ions keep mailing lists up-to-date as postal addre...
Other Biology Technology:
(Date:11/26/2009)...er 26, 2009) Whitehead researchers have developed...inpoint specific genes and proteins used by pathog... most human cell cultures genes are present in two...m the mother. Gene inactivation by mutation is the...vated, the second copy usually remains active and ...
(Date:11/25/2009)...n,t have easy lives. In addition to mammalian immu...l enemies called bacteriophages, viruses that kill...till, bacteria and another class of microorganisms...onments such as deep-sea volcanic vents) manage ju...ilt-in defense system that helps protect them from...
(Date:11/25/2009)...y assistant professors recently received funding f...nue research beneficial to understanding the envir...topher Blackwood, assistant professor in the Depar...o support two separate research projects. , His ...r Communities and Functions from the Leaf to the L...
Breaking Biology News(10 mins):Knockouts in human cells point to pathogenic targets 2Researchers discover biological basis of 'bacterial immune system' 2Researchers discover biological basis of 'bacterial immune system' 3Kent State University professors focus research on the environment with grants totaling $890,000 2Reportlinker Adds US Orthopedic Devices Market Analysis 26amp 3B Forecasts to 2015 6234 1Reportlinker Adds US Orthopedic Devices Market Analysis 26amp 3B Forecasts to 2015 6234 2Reportlinker Adds US Orthopedic Devices Market Analysis 26amp 3B Forecasts to 2015 6234 3Reportlinker Adds US Orthopedic Devices Market Analysis 26amp 3B Forecasts to 2015 6234 4Reportlinker Adds US Orthopedic Devices Market Analysis 26amp 3B Forecasts to 2015 6234 5Reportlinker Adds US Orthopedic Devices Market Analysis 26amp 3B Forecasts to 2015 6234 6Reportlinker Adds US Orthopedic Devices Market Analysis 26amp 3B Forecasts to 2015 6234 7Reportlinker Adds US Orthopedic Devices Market Analysis 26amp 3B Forecasts to 2015 6234 8Reportlinker Adds US Orthopedic Devices Market Analysis 26amp 3B Forecasts to 2015 6234 9Reportlinker Adds US Orthopedic Devices Market Analysis 26amp 3B Forecasts to 2015 6234 10Reportlinker Adds US Orthopedic Devices Market Analysis 26amp 3B Forecasts to 2015 6234 11Reportlinker Adds US Orthopedic Devices Market Analysis 26amp 3B Forecasts to 2015 6234 12Reportlinker Adds US Orthopedic Devices Market Analysis 26amp 3B Forecasts to 2015 6234 13Reportlinker Adds US Orthopedic Devices Market Analysis 26amp 3B Forecasts to 2015 6234 14Reportlinker Adds US Orthopedic Devices Market Analysis 26amp 3B Forecasts to 2015 6234 15Reportlinker Adds US Orthopedic Devices Market Analysis 26amp 3B Forecasts to 2015 6234 16Reportlinker Adds US Orthopedic Devices Market Analysis 26amp 3B Forecasts to 2015 6234 17Sonic Innovations Named as CES Innovations 2010 Design and Engineering Award Honoree 6229 1Sonic Innovations Named as CES Innovations 2010 Design and Engineering Award Honoree 6229 2Sonic Innovations Named as CES Innovations 2010 Design and Engineering Award Honoree 6229 3Transcept Pharmaceuticals Reports Third Quarter 2009 Financial Results 6224 1Transcept Pharmaceuticals Reports Third Quarter 2009 Financial Results 6224 2Transcept Pharmaceuticals Reports Third Quarter 2009 Financial Results 6224 3Transcept Pharmaceuticals Reports Third Quarter 2009 Financial Results 6224 4Transcept Pharmaceuticals Reports Third Quarter 2009 Financial Results 6224 5Transcept Pharmaceuticals Reports Third Quarter 2009 Financial Results 6224 6Transcept Pharmaceuticals Reports Third Quarter 2009 Financial Results 6224 7Transcept Pharmaceuticals Reports Third Quarter 2009 Financial Results 6224 8Transcept Pharmaceuticals Reports Third Quarter 2009 Financial Results 6224 9Transcept Pharmaceuticals Reports Third Quarter 2009 Financial Results 6224 10Transcept Pharmaceuticals Reports Third Quarter 2009 Financial Results 6224 11Transcept Pharmaceuticals Reports Third Quarter 2009 Financial Results 6224 12
...New-generation artificial cornea could restore vis...s , An improved artificial cornea, which could r...orldwide who are blind due to diseased corneas, fi...fornia conclude in a new analysis of research on t...issue of ACS, Biotechnology Progress, a bi-monthly...
...International (SER) released its May 2008 Briefing...cal Restoration & Biological Conservation within t...cal Diversitys Ninth Conference of the Parties hel...ing Note states that the Ecosystem Approach, as de...comprehensive framework where ecological restorati...
...tists, plumbing the secrets of a vast underwater m...irst images of a novel Brittlestar City establishe... an underwater summit taller than the worlds talle...nts, tens of millions living arm tip to arm tip, o... swirling circumpolar current flowing over and aro...
Other Biology News:American Chemical Society's Weekly PressPac -- May 14, 2008 2American Chemical Society's Weekly PressPac -- May 14, 2008 3American Chemical Society's Weekly PressPac -- May 14, 2008 4American Chemical Society's Weekly PressPac -- May 14, 2008 5American Chemical Society's Weekly PressPac -- May 14, 2008 6American Chemical Society's Weekly PressPac -- May 14, 2008 7American Chemical Society's Weekly PressPac -- May 14, 2008 8Integrating restoration and conservation within the ecosystem approach 2Explorers marvel at 'Brittlestar City' on seamount in powerful current swirling around Antarctica 2Explorers marvel at 'Brittlestar City' on seamount in powerful current swirling around Antarctica 3Explorers marvel at 'Brittlestar City' on seamount in powerful current swirling around Antarctica 4
Rabbit Anti-Human MSY2 / YBOX2 Polyclonal Antibody, Unconjugated from Abcam
Rabbit Anti-Human YANK2 Polyclonal Antibody, Unconjugated from Abcam
Giemsa stain from Sigma-Aldrich
Bovine Serum, Sterile Filtered from Meridian Life Science, Inc.
Biology Products: