FDA Offers Special Protocol Assessment for Reviroc
AMSTERDAM, December 19 /PRNewswire/ -- Kiadis Pharma announced today that it has successfully completed an End of Phase II meeting for Reviroc with the U.S. Food and Drug Administration (FDA). Reviroc is under development for elimination of cancer cells from an autologous graft in bone marrow transplantations for end-stage blood cancer patients. The FDA agreed that the data from the completed phase II clinical Reviroc trial is sufficient to support the start of a phase III study. The FDA offered Kiadis Pharma its Special Protocol Assessment (SPA) procedure allowing Kiadis Pharma to work directly with the FDA to optimize the clinical design of the trial.
The FDA meeting followed the successful completion of a multi centre phase II study for Reviroc showing an improved overall survival after autologous bone marrow transplantation in Non-Hodgkin's lymphoma patients. The phase III clinical trial design for Reviroc will focus on patients with Large B cell lymphoma. Kiadis Pharma anticipates filing of the IND, SPA request and Orphan Drug Designation application with the FDA within the next few weeks.
"We are very pleased with the outcome of the End of Phase II meeting with the FDA and with the possibility to access the FDA's Special Protocol Assessment program. Together with the strong support by our principal investigators we are well prepared to design a clear path towards marketing authorization for Reviroc," said Manja Bouman, CEO Kiadis Pharma.
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 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 and the fact that the patients' own white blood cells does not fight the cancer. Reviroc has been developed to remove residual tumor cells from the graft.
English release is provided by Kiadis Pharma. Equivalent translations are from a third party.
|SOURCE Kiadis Pharma|
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