The US Food and Drug Administration (FDA) has approved a phase III clinical trial for a new cancer drug, manufacturer Kiadis Pharma said.
Reviroc is being developed to eliminate cancer cells from autologous grafts in bone marrow transplantations for end-stage blood cancer patients.
The FDA decision follows a successful phase II study which found the drug can be effective at reducing cancer cells in patients prior to transplantation.
An autologous transplant uses the patient’s own bone marrow to serve as graft. Bone marrow transplants are seen as a viable option for patients suffering from blood cancers, such as leukaemia and lymphoma.
But one of the limitations of autologous bone marrow transplantations is the high relapse rate associated with the procedure.
This is often caused by the presence of cancer cells in the transplant, and it is now hoped that Reviroc can remove these tumour cells from the graft.
Manja Bouman, CEO of Kiadis Pharma, said: “We are very pleased with this investigational new drug approval received from the FDA and look forward to completing the Special Protocol Assessment as well to allow us to start enrolment of patients in the study.”
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