Gamida Cell’s StemEx® Achieves Primary Endpoint in Phase II/III Clinical Study

  Gamida Cell’s StemEx® Achieves Primary Endpoint in Phase II/III Clinical
  Study

Business Wire

JERUSALEM -- February 4, 2013

Gamida Cell announced today that its flagship product, StemEx, reached its
primary endpoint of improving overall survival in a Phase II/III study which
compared the use of StemEx as part of a transplantation regimen to historical
controls in the treatment of patients with hematological malignancies such as
leukemia and lymphoma.

The primary endpoint is defined as the rate of mortality (%) within 100 days
after transplantation. For the final analysis, the historical control cohort
was comprised of a similar group of patients each transplanted with double
cord blood during the years 2006-2010. The analysis shows 15.8% mortality in
the StemEx group and 24.5% in the control group (p=0.034). A complete analysis
of the data will be available in a few weeks.

Twenty-five bone marrow transplantation centers worldwide treating 101
patients with hematologic malignancies following myleoablative therapy who
could not find a family related matched bone marrow donor participated in the
study.

“We are delighted with today’s results of the Phase II/III study of StemEx. We
remain focused on completing the development of StemEx as an alternative
stem/progenitor cell source for transplantation in patients who cannot find a
family related matched bone marrow donor,” said Dr. Yael Margolin, president
and CEO of Gamida Cell.

Mr. Ruben Krupik, chairman of the board of Gamida Cell, said, “We are very
pleased to learn that StemEx has achieved the primary endpoint in the Phase
II/III study. This is a major milestone on the road to bringing this very
important therapy to market.”

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
administration along with the remaining, non-manipulated cells from the same
unit. Cord blood has less matching requirements than bone marrow or peripheral
blood transplants, providing the potential to increase the number of suitable
transplant matches and to shorten the time it can take to find a match.
However, there are a limited number of stem/progenitor cells in cord blood,
enabling a quantity sufficient generally only for pediatric treatment. StemEx
employs a technology that expands this small number of cord blood
stem/progenitor cells, increasing their therapeutic capacity for
transplantation in adolescents and adults.

To date, StemEx has been developed by the Gamida Cell-TEVA Joint Venture,
equally owned by Gamida Cell and TEVA Pharmaceutical Industries. The Joint
Venture owns all global rights for the commercialization of StemEx. Gamida
Cell is currently seeking a strategic partner for the global commercialization
of StemEx.

About Gamida Cell

Gamida Cell is a world leader in stem cell population expansion technologies
and stem cell therapy products for transplantation and regenerative medicine.
The company’s pipeline of stem cell therapy products are in development to
treat a wide range of conditions including blood cancers, solid tumors,
non-malignant hematological diseases such as hemoglobinopathies, neutropenia
and acute radiation syndrome, autoimmune diseases and metabolic diseases as
well as conditions that can be helped by regenerative medicine. Gamida Cell’s
therapeutic candidates contain populations of adult stem cells, selected from
non-controversial sources such as umbilical cord blood, bone marrow and
peripheral blood, which are expanded in culture. Gamida Cell’s current
shareholders include: Elbit Imaging (NASDAQ: EMITF), Clal Biotechnology
Industries (TASE: CBI), Israel Healthcare Venture, Teva Pharmaceutical
Industries (NADAQ: TEVA), Amgen, Denali Ventures and Auriga Ventures. For more
information, please visit: www.gamida-cell.com.

Contact:

Gamida Cell
Marjie Hadad, +972-54-536-5220
Media Liaison/IR
marjie@gamida-cell.com
 
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