Promising Phase II Clinical Trial Results for Reviroc
(NL version) | go backGroningen, August 31, 2007 – Oncology focused pharmaceutical development company Kiadis Pharma announced today that it has successfully completed a Phase II clinical trial evaluating its product Reviroc™. Reviroc is used to eliminate cancer cells from an autologous graft in bone marrow transplantations for end-stage blood cancer patients. Data from the clinical study revealed improved overall survival of Reviroc-treated patients. The successful completion of the clinical trial allows Kiadis Pharma to prepare for a Phase III clinical study.
Manja Bouman, CEO, Kiadis Pharma, comments: "We are obviously very pleased with the completion of this Phase II trial of Reviroc. It brings treatment with our product a step closer to patients with end stage blood cancer. Reviroc shares its development platform with two other Kiadis Pharma products: ATIR and Rhitol. The results of this trial therefore mark an important milestone in the development of our entire clinical product pipeline.”
In the non-randomized open label study 25 patients, each of whom had reached end stage Non-Hodgkin’s lymphoma, were treated in multiple centers in Canada. The objective of the study was to determine the safety of the Reviroc treatment and its ability to eliminate cancer cells from a contaminated graft. Reviroc-treated grafts all showed excellent engraftment, indicating that Reviroc does not negatively impact the graft itself.
The Reviroc clinical trial data was evaluated against a historical patient control group from the Center for International Blood and Marrow Transplant Research (CIBMTR). The results for Reviroc-treated patients were compared with results from the CIBMTR database for patients who had received an autologous transplant without Reviroc. The outcome of this comparison shows that the Reviroc-treated patient group had an 80% chance of survival at 3 years post transplantation, while the CIBMTR control group had a 55% chance of survival at 3 years post transplantation. Based on these promising data, Kiadis Pharma will prepare for a clinical phase III study of Reviroc.
Dr. Denis-Claude Roy at Maisonneuve-Rosemont Hospital in Montreal, commented: “After more then five years of clinical research, we believe that our results demonstrate that Reviroc is able to improve patient survival. This is potentially a breakthrough achievement for patients suffering from Non-Hodgkin’s lymphoma as well as their families.”
About Reviroc
Reviroc is being developed as a treatment that eliminates blood cancer cells from autologous transplants for patients with end stage blood cancer. An autologous transplant uses the patient’s own bone marrow to serve as a graft. Bone marrow transplantations are broadly recognized as a treatment option for patients suffering from blood cancers, such as leukemia and lymphoma. Reviroc has been developed to remove residual tumor cells from the graft.
