Kiadis Pharma Obtains FDA Approval to Start a Phase III Clinical Trial for Reviroc(TM) in the United States

FDA Approves IND Application for Reviroc(TM)

Feb 22, 2008, 00:00 ET from Kiadis Pharma

    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.
     About Reviroc(TM)
     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