AMSTERDAM, November 19 /PRNewswire/ -- Kiadis Pharma announced today that it has agreed to provide Rhitol during a limited period of time to requesting physicians participating in the ongoing phase I/II trial. The Rhitol phase I/II trial is closed for enrolment to treat new patients and is expected to complete at the end of this year. Kiadis Pharma anticipates applying for and starting a phase III study in 2008.
Manja Bouman, CEO Kiadis Pharma commented: "We realised that the sites participating in the ongoing phase II trial were left without treatment alternatives following the announcement of the enrolment closure. The interest these physicians show in using our product for new patients is very encouraging and we are very pleased that we can support them by providing Rhitol through special provisions, until the start of the phase III clinical trial."
The physicians interested in enabling new patients to receive treatment with Rhitol will obtain regulatory authorization from the appropriate agency to allow for compassionate use of Rhitol.
Rhitol is under development for patients with severe chronic steroid refractory Graft versus Host Disease (GvHD) who have exhausted other treatment options. Chronic GvHD is a condition that can develop after allogeneic bone marrow transplantation and resembles an autoimmune disease. The immune cells from the donor graft cause GvHD by attacking the patient's tissues and organs. There are two forms of GvHD: acute GvHD appears within 100 days after transplantation and chronic GvHD begins anytime after that period. Immune-suppressant drugs, such as steroids, are generally used to treat chronic GvHD. The disease can become a life-threatening condition when standard treatment cannot control its progression as the patient either does not respond to steroid treatment or develops severe side effects due to their use. Extensive chronic GvHD affects multiple organs and tissues and results in diminished quality of life for patients.
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Certain statements in this announcement are forward-looking statements. Such statements are based on current expectations and are subject to a number of risks and uncertainties that could cause actual results or events to differ materially from those expressed and implied by the forward-looking statements
|SOURCE Kiadis Pharma B.V.|
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