Navigation Links
Kiadis Pharma Receives Orphan Drug Designation for Rhitol(TM) From the FDA
Date:4/15/2008

AMSTERDAM, April 15 /PRNewswire/ -- Biopharmaceutical company Kiadis Pharma announced today that the U.S. Food and Drug Administration (FDA) has granted its product Rhitol(TM) Orphan Drug Designation for the treatment of chronic Graft versus Host Disease (GvHD). This complication of allogeneic bone marrow transplantation is highly disabilitating and can become life threatening when the patient is unresponsive to steroid treatment. Rhitol(TM) has completed a multicenter phase I/II study for patients with severe steroid resistant chronic GvHD. A phase III study is anticipated to start in 2008.

"The decision by the FDA to grant Rhitol(TM) orphan drug designation in this area of blood cancer with unmet medical need advances our efforts to develop an innovative treatment" says Dr. Manja Bouman, Chief Executive Officer of Kiadis Pharma.

The FDA's orphan drug designation is reserved for new therapies being developed to treat diseases or conditions that affect fewer than 200,000 people in the United States. The orphan drug designation provides for an accelerated review process, tax benefits, exemption from user fees and a seven-year period of market exclusivity in the United States after product approval.

About Rhitol(TM)

Rhitol(TM) is under development as a treatment for patients with chronic GvHD resistant or intolerant to immunosuppressive agents. Rhitol(TM) treatment targets activated T cells that cause GvHD and results in immune modulation within patients with chronic GvHD, restores immune tolerance and attempts to achieve disease remission.

About chronic GvHD

GvHD is a condition that can develop after allogeneic bone marrow transplantation and resembles an autoimmune disease. Graft versus Host Disease is caused by immune cells from the donor graft attacking the patient's tissues and organs. Chronic GvHD usually develops some time after the transplantation and is generally treated by immunosuppressive drugs, such as steroids. The disease can however become life threatening when standard treatment cannot control its progression and the patient does not respond to additional immunosuppressive treatment or develops severe side effects to their use. Patients with extensive chronic GvHD have multiple organs and tissues affected and in general have a very poor quality of life.


'/>"/>
SOURCE Kiadis Pharma
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. Kiadis Pharma Reports Successful End of Phase II Meeting With FDA for Reviroc
2. Hearing Scheduled in the Delaware Court of Chancery for August 27, 2007 to Establish the Valid Approval and Consummation of the Merger Between PharmAthene, Inc. and Healthcare Acquisition Corp.
3. Pharmatek Adds Cytotoxic and High-Potent Drug Development Capabilities to San Diego Laboratory
4. Vion Pharmaceuticals Pays Interest on 7.75% Convertible Senior Notes
5. Skystar Bio-Pharmaceutical Announces Second Quarter 2007 Results
6. Proceedings to Affirm Merger Between PharmAthene and Healthcare Acquisition Corp Initiated in Delaware Chancery Court
7. China Biopharmaceuticals Holdings Announces Second Quarter 2007 Financial Results
8. Vion Pharmaceuticals Completes Accrual of 85 Patients to its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in Elderly AML
9. XTL Biopharmaceuticals Announces Financial Results for the Six Months Ended June 30, 2007
10. Dragon Pharmaceutical Reports Growth in Sales and Profits during Second Quarter of 2007
11. Cadence Pharmaceuticals Reports Second Quarter 2007 Financial Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/4/2016)... ... , ... Many of the engineers at FireflySci, Inc. have been manufacturing quartz ... from other cuvette manufacturers is their supercharged customer service and their extensive database of ... steady flow of inside information, they have recently revamped their manufacturing techniques to reduce ...
(Date:2/3/2016)... WARRINGTON, Pa. , Feb. 3, 2016 /PRNewswire/ ... biotechnology company focused on developing aerosolized KL4 surfactant ... Board of Directors has approved an inducement award ... Craig Fraser , its newly appointed President and ... the Board,s Compensation Committee on February 1, 2016 ...
(Date:2/3/2016)... Feb. 3, 2016 Ascendis Pharma A/S (Nasdaq: ... applies its innovative TransCon technology to address significant unmet ... upcoming investor conference.Event:2016 Leerink Partners Global Healthcare Conference Location: ... Wednesday, February 10, 2016 Time:  , 11:55am EST ... --> An audio webcast of this event ...
(Date:2/3/2016)... Feb. 3, 2016 New Jersey Health Foundation ... $1 million for researchers in New ... research that demonstrates exciting potential.   ... for the New Jersey Health Foundation Research Grant ... these educational institutions— Princeton University, Rutgers University, Rowan ...
Breaking Biology Technology:
(Date:1/20/2016)... SAN JOSE, Calif. , Jan. 20, 2016 ... leading developer of human interface solutions, today announced ... touch controller solution for wearables and small screen ... appliances such as printers. Supporting round and rectangular ... the S1423 offers excellent performance with moisture on ...
(Date:1/13/2016)... ALBANY, New York , January 13, 2016 /PRNewswire/ ... Transparency Market Research has published a new market report ... Share, Growth, Trends, and Forecast, 2015 - 2023. According to ... mn in 2014 and is anticipated to reach US$1,625.8 ... from 2015 to 2023. In terms of volume, the ...
(Date:1/11/2016)... 11, 2016  higi, the leading retail and ... locations, web and mobile, today announced it has ... existing investors. --> ... further innovate higi,s health platform – its network ... – including expanding services and programs to retail ...
Breaking Biology News(10 mins):