JERUSALEM, April 11 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
"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