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 marketing exclusivity after gaining FDA approval, as well as clinical study incentives, study design assistance, waivers of certain FDA user fees, and potential tax credits.

About Delcath Systems, Inc.

Delcath Systems, Inc. is a medical technology company specializing in cancer treatment. The Company is testing a proprietary, patented drug delivery system for the treatment of 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. 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-seven 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.

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.
Copyright©2009 PR Newswire.
All rights reserved

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:10/11/2017)... ... 2017 , ... ComplianceOnline’s Medical Device Summit is back for its 4th year. ... San Francisco, CA. The Summit brings together current and former FDA office bearers, regulators, ... government officials from around the world to address key issues in device compliance, quality ...
(Date:10/11/2017)... and LAGUNA HILLS, Calif. , ... of Cancer Research, London (ICR) and ... with SKY92, SkylineDx,s prognostic tool to risk-stratify patients with multiple ... as MUK nine . The University of ... is partly funded by Myeloma UK, and ICR will perform ...
(Date:10/11/2017)... ... October 11, 2017 , ... ... granted orphan drug designation to SBT-100, its novel anti-STAT3 (Signal Transducer and Activator ... osteosarcoma. SBT-100 is able to cross the cell membrane and bind intracellular STAT3 ...
(Date:10/10/2017)... ... October 10, 2017 , ... ... FirstHand program has won a US2020 STEM Mentoring Award. Representatives of the FirstHand ... Excellence in Volunteer Experience from US2020. , US2020’s mission is to change the ...
Breaking Biology Technology:
(Date:4/4/2017)... April 4, 2017   EyeLock LLC , a ... the United States Patent and Trademark Office (USPTO) has ... the linking of an iris image with a face ... represents the company,s 45 th issued patent. ... very timely given the multi-modal biometric capabilities that have ...
(Date:3/30/2017)... March 30, 2017 The research team of ... three-dimensional (3D) fingerprint identification by adopting ground breaking 3D fingerprint minutiae ... realm of speed and accuracy for use in identification, crime investigation, ... cost. ... A research ...
(Date:3/28/2017)... The report "Video Surveillance Market ... Storage Devices), Software (Video Analytics, VMS), and Service (VSaaS, ... to 2022", published by MarketsandMarkets, the market was valued ... to reach USD 75.64 Billion by 2022, at a ... year considered for the study is 2016 and the ...
Breaking Biology News(10 mins):