Kiadis Pharma Receives Orphan Drug Designation for Rhitol(TM) From the FDA
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
For more information please contact: Kiadis Pharma, Eefje Simpelaar, Director Communications, Email: e.simpelaar@kiadis.com, Tel: +31-20-8884815, Mob: +31-610829344
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