AMSTERDAM, Nov. 19 /CNW/ - 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
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.
For further information:
For further information: Kiadis Pharma B.V., Eefje Simpelaar, Director
Communications, Email: email@example.com, Tel: +31-208884802, Mob: