BioWorld International Correspondent

ZICHRON YAAKOV, Israel - Gamida-Cell Ltd. is riding on the results of its Phase I/II study, which showed that its cord blood stem cell therapeutic product, StemEx, has the potential to provide the donor material for the majority of the patients who cannot find matching bone marrow donors.

That product now will be funded by an investment of $25 million by Teva Pharmaceutical Industries Ltd., which said Tuesday that it has exercised the option to enter a joint venture with Gamida-Cell to develop and commercialize StemEx in leukemia and lymphoma.

The option was part of a Teva investment in Gamida-Cell made in 2003. Gamida-Cell CEO Ehud Marom said, "It is our intention to begin the pivotal Phase II/III study of StemEx and secure fast-track designation based on patient need and demand."

Teva and Gamida have planned meetings with the FDA and European regulatory agencies to finalize parameters for the study, which they hope to initiate in the second half of the year.

Currently, only 15 percent of patients requiring bone marrow transplantation who do not have genetically matched relatives are able to find matching donors.

StemEx, cord blood enriched with stem cells, was developed by Gamida-Cell based on discoveries and innovations made at the Hadassah University Hospital in Jerusalem.

Teva has accelerated and enlarged its biotechnology thrust during the past few years under the guidance of Aaron Schwartz, who has spearheaded Copaxone research and development. Teva president and CEO Israel Makov said the investment and option are part of a strategy to enter the cell therapy field. As part of that, Teva led the Israeli government-funded cell therapy consortium "Genesis," and, in addition to Gamida-Cell, invested in Proneuron, an Israeli company developing cell-based therapies for complete spinal cord injury.

Major shareholders in Gamida-Cell, which deals in the expansion of blood stem cell therapeutics in cancer and autoimmune diseases, as well as future regenerative cell-based medicines including cardiac and pancreatic repair, are Elscint (Europe-Israel), Biomedical Investments, Denali Ventures, Teva, Auriga Ventures, Pamot and Comsor.