AMSTERDAM, February 22 /PRNewswire/ -- 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 Reviroc(TM)
in the United States. Reviroc(TM) 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 Reviroc(TM) 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(TM) 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.
Reviroc(TM) 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 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.
Reviroc(TM) has been developed to remove tumor cells from the graft.
About Kiadis Pharma
Kiadis Pharma is a biopharmaceutical company focused specifically on
complications and limitations of bone marrow transplantations in blood
cancer patients. The company has three blood cancer products in clinical
development, offering novel treatment options for terminally ill cancer
patients and address high-unmet medical needs.
SOURCE Kiadis Pharma