Kiadis Pharma obtains FDA approval to start a phase III clinical trial for Reviroc™ in the United States. FDA approves IND application for Reviroc™
Biopharmaceutical company Kiadis Pharma announced today that the US Food and Drug Administration (FDA) approved Kiadis Pharma’s investigational new drug (“IND”) application to allow the start of a clinical phase III study for its product RevirocTM in the United States. RevirocTM is under development for the elimination of cancer cells from an autologous graft in bone marrow transplantations for end-stage blood cancer patients.
This approval follows the successful End of Phase II meeting with the FDA for RevirocTM and the subsequent submission of the IND package to the FDA. As part of the End of Phase II meeting the FDA offered its Special Protocol Assessment (SPA) for Reviroc™ for protocol design of a phase III clinical study. Kiadis Pharma will initiate the start of a phase III study upon completion of the SPA.
The completed phase II study has shown an effective elimination of cancer cells from the patients autologous bone marrow graft prior to the transplantation and shows an encouraging overall survival after autologous bone marrow transplantations in Non-Hodgkin’s lymphoma patients.
“We are very pleased with this IND approval received from the FDA and look forward to completing the SPA as well to allow us to start enrolment of patients in the study”, commented Manja Bouman, CEO of Kiadis Pharma.
About RevirocTM
RevirocTM 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 transplants are broadly recognized as a treatment option for patients suffering from blood cancers, such as leukemia and lymphoma. One of the limitations of autologous bone marrow transplantations is the high relapse rate associated with this treatment. This is often caused by the presence of cancer cells in the transplant. RevirocTM has been developed to remove tumor cells from the graft.
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