Kiadis Pharma announces successful completion of Rhitol™ Phase II clinical study
(NL version) | go backOncology focused biopharmaceutical product development company Kiadis Pharma announced today that it has successfully finalized its Rhitol™ Phase II clinical trial with the last patient completing its six month treatment cycle. Rhitol™ is evaluated as treatment for patients with extensive chronic Graft versus Host Disease (GvHD) intolerant or resistant to standard immunosuppressive treatment.
The current preliminary clinical results demonstrate an excellent safety profile for Rhitol™ and evidence of efficacy in the alleviation of the symptoms associated with chronic Graft versus Host Disease. After this clinical study was closed for enrollment mid 2007 Kiadis Pharma allowed new patients to be treated under a compassionate protocol. The successful completion of the Phase II clinical trial of Rhitol™ paves the way for a phase III study and Kiadis Pharma is planning to file for a phase III multi center clinical trial in the USA and Canada within the next few months.
Manja Bouman, CEO Kiadis Pharma comments: “We are very pleased with the positive outcome of this study and the potential shown by Rhitol™. This product would fulfill a significant unmet medical need since patients with chronic GvHD resistant or intolerant to immunosuppressive drugs have no other standard treatment option available to them and this disease can subsequently develop into a life-threatening condition”.
About Rhitol™
Rhitol™ is under development as a treatment option for patients with chronic GvHD resistant or intolerant to immunosuppressive agents. Rhitol™ treatment eliminates 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 a life-threatening condition. This occurs when standard treatment cannot control its progression as the patient either does not respond to immunosuppressive treatment or develops severe side effects to their use. Patients with extensive chronic GvHD have multiple organs and tissues affected and in general a very poor quality of life.
