JERUSALEM, April 11 (Reuters) - Gamida Cell, a developer of stem cell therapy products, plans to meet the U.S. Food and Drug Administration and European Medicines Agency in the coming months to discuss the regulatory path for marketing approval for its StemEx treatment, its chief executive said.
StemEx is used as part of a transplant regimen for patients with high risk leukaemia and lymphoma. Phase II/III clinical trials found the treatment improves survival 100 days after a transplant.
“Phase II/III data suggests that StemEx can serve as an alternative transplant treatment for patients who cannot find a matched bone marrow donor,” CEO Yael Margolin said in a statement on Thursday.
“The company plans to meet with the FDA this spring and with the EMA this autumn to continue discussions on the regulatory pathway for marketing approvals.”
StemEx is being developed by a joint venture between Israel-based Gamida Cell and generic drugmaker Teva Pharmaceutical Industries . The venture said it is seeking a strategic partner for the global commercialisation of StemEx.
Gamida Cell is privately owned by Teva, Elbit Imaging , Clal Biotechnology Industries, Israel Healthcare Venture, Amgen, Denali Ventures and Auriga Ventures.