Kiadis Pharma Completes Patient Enrollment of Rhitol phase I/II Clinical Trial
(NL version) | go backGroningen, August 17, 2007 – Oncology focused pharmaceutical company Kiadis Pharma announced today that it has enrolled the last patient in its Phase I/II clinical trial of Rhitol™ that is being conducted in Canada and the United States. The patients enrolled in the clinical trial were randomized to either a low or a high dose to evaluate Rhitol as a treatment option for patients with extensive steroid resistant or intolerant chronic Graft versus Host Disease (GvHD). Rhitol would fulfill a significant unmet medical need since patients with steroid resistant or intolerant chronic GvHD have no other standard treatment options available and this disease can subsequently develop into a life-threatening condition.
As of today, a total of 20 patients have been enrolled in the trial and 10 patients have already completed the six months treatment period of Rhitol. So far no treatment related toxicities were reported. Furthermore participating investigators noted in an end of enrollment survey that Rhitol treatment was beneficial to approximately 90% of the patients who had completed the treatment. This survey showed that treating physicians observed a noticeable improvement of their patients’ chronic GvHD manifestations and/or a reduction in their immunosuppressive agents as well as an improved quality of life for these patients. Investigators commented that Rhitol treatment was safe and well tolerated by patients so far. The final results of the phase I/II trial are expected to be available in early 2008.
Manja Bouman, CEO, Kiadis Pharma, comments: "We are pleased to announce the completion of enrollment in our Phase I/II study of Rhitol. Based upon the investigators’ feedback from the end of enrollment survey we are confident about the progression of Rhitol. We very much appreciate the contribution of our clinical investigators, their teams, and the patients involved in this important clinical study.”
GvHD is a condition that can develop after bone marrow transplantation and resembles an autoimmune disease. GvHD is caused by the immune cells from the donor graft which starts attacking the patient’s tissues and organs. There are two forms of GvHD. Acute GvHD appears usually within 100 days after transplantation and chronic GvHD begins anytime after that period. Chronic GvHD is generally treated by immunosuppressant drugs, such as steroids. The disease can become a life-threatening condition when standard treatment cannot control its progression as the patient either does not react to steroid 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.
About Rhitol
Rhitol is under development for patients with steroid resistant or intolerant chronic GvHD in patients who have received bone-marrow transplantation. Rhitol uses a small molecule that selectively accumulates in reactive immune cells, including T-cells that cause GvHD, and upon photo-activation, eliminates these cells. Blood cells are collected from the patient, treated and subsequently re-infused. Rhitol is designed to result in immune modulation within the patient, restoring immune tolerance and attempting to achieve disease remission.
