Kiadis Pharma announced 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 info 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 ask 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.

Original post by Mallows