FDA Approves IND Application for Reviroc(TM)
AMSTERDAM, Feb. 22 /CNW/ - 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
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.
For further information:
For further information: Kiadis Pharma B.V., Eefje Simpelaar, Director
Communications, email@example.com, +31-20-8884815