Gamida Cell - Cord Blood Transplant

StemEx®

StemEx®, Gamida Cell’s‚ flagship product, addresses an unmet clinical need for patients with hematological malignancies (blood cancers). StemEx is being developed by a Joint Venture (JV) of Gamida Cell and TEVA Pharmaceutical Industries (NASDAQ: TEVA).

StemEx has blockbuster potential in the field of bone marrow transplantation, in supplying alternative cell grafts to patients without a matched, related bone marrow donor.

StemEx is a graft of an expanded population of stem/progenitor cells, derived from part of a single unit of umbilical cord blood and transplanted by IV along with non-manipulated cells from the other part of the unit.

The Phase I/II safety study was conducted at the M. D. Anderson Cancer Center in Houston, Texas. A summary of the clinical data from this study is presented in the table below:

The results of the Phase I/II trial led to the commencement of the global, pivotal registration, Phase II/III study of StemEx® called ExCell, now enrolling patients at leading cord blood transplant centers in the U.S., Europe and Israel. ExCell is studying the safety and efficacy of StemEx as a treatment for hematological malignancies including leukemia and lymphoma.

The clinical protocol received a Special Protocol Assessment from the FDA. StemEx was also granted an orphan drug designation in the US and Europe. The JV anticipates the market launch of StemEx will be in 2011. For more information regarding ExCell, please visit www.stemexstudy.com.

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