AMSTERDAM, April 15 /CNW/ - 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.
For further information: Kiadis Pharma, Eefje Simpelaar, Director
Communications, Email: e.simpelaar@kiadis.com, Tel: +31-20-8884815, Mob:
+31-610829344
