Gamida Cell is dedicated to making a significant difference in the clinical practice of modern medicine by first creating, then tapping the regenerative power of therapeutic stem cells.
Umbilical cord blood is a readily-available, non-controversial source of stem cells for patients indicated for bone marrow transplantation. The use of cord blood minimizes the risk to the donor. In addition, compared with bone marrow or peripheral blood, the transplantation of umbilical cord blood cells requires less stringent HLA-matching, thus significantly increasing the chances for finding a matched donor unit. However, there is a challenge that exists: as the number of stem cells in a cord blood unit is relatively small, use in adolescent and adult patients has traditionally been limited.
Gamida Cell's proprietary technologies enrich and expand the numbers of homogenous stem cells in culture. These enabling technologies are simple, reversible, do not involve genetic interference, and are easily scalable. They are additionally cost effective and efficient for commercial production.
Gamida Cell's flagship product, StemEx®, is currently being studied as a treatment for hematological malignancies or "blood cancers" including leukemia and lymphoma in a single arm, global, pivotal Phase II/III, registration study. The study, called ExCell, is now recruiting patients at prestigious cord blood transplant centers in the US, Europe and Israel. The clinical protocol has received a Special Protocol Assessment by the FDA. In addition, StemEx was granted an orphan drug designation in the US and Europe. The Gamida Cell-TEVA JV anticipates that the market launch of StemEx will be in 2011. For more information regarding ExCell, please visit www.stemexstudy.com.
Gamida Cell also signed a license agreement with Amgen (NASDAQ:AMGN) to support development and commercialization of StemEx for hematological malignancies. |
