Healthcare Industry News:  cord blood 

Regenerative Medicine FDA

 News Release - November 2, 2006

Gamida Cell's StemEx(R) Registration Study Receives Special Protocol Assessment from the FDA

JERUSALEM--(HSMN NewsFeed)--Gamida Cell Ltd., developer of stem cell therapeutics, announced today that it has reached an agreement under a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA) on the design of the global, pivotal, historical controlled registration study of StemEx® for the treatment of hematological malignancies. Gamida Cell is developing StemEx® in a Joint Venture with Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA ).

In response to the SPA application, the FDA stated in an official reply letter that "...the design and planned analysis of your study sufficiently address the study's objectives and that this study is adequately designed to provide the necessary data that, depending upon outcome, could support a license application submission."

"We have worked hard, together with the FDA, to sculpt the design and analysis of the study. Conducting a pivotal study under an SPA is an important achievement. Among other advantages, it provides an agreed upon roadmap for the management and analysis of the study's data, and thus reduces some of the risks involved in seeing a product to market. Assuming that all of the study endpoints are met, we are confident that, together with Teva, we will be able to bring StemEx® to the market in 2009 as planned," said Gamida Cell CEO Dr. Yael Margolin.

Stem cell transplantation is a life saving procedure for patients with high-risk hematological malignancies. Currently, many adult and adolescent patients lack a suitable marrow donor. StemEx® may provide an alternative source of stem cells for these patients by enabling the use of cord blood for transplantation. StemEx® is composed of ex-vivo expanded cord blood stem/progenitor cells, which are transplanted in combination with non-expanded cells from the same cord blood unit. The Phase I/II study of StemEx®, conducted at the M. D. Anderson Cancer Center in Texas, showed safety and trends of efficacy. The study, which is set to commence soon, will be managed by Gamida Cell's medical director, Dr. Yael Cohen, who was responsible for the design of this pivotal study. StemEx® was granted an FDA Orphan Drug designation in March 2005.

About Gamida Cell

Gamida Cell is developing a line of cell therapy products for the treatment of debilitating and fatal diseases with unmet clinical needs. The Company is dedicated to making a significant difference in the clinical practice of modern medicine by first producing, then tapping into the regeneration power of an ample body of therapeutic stem cells. StemEx®, Gamida Cell's flagship product, is in advanced clinical development for the treatment of hematological diseases. Gamida Cell has an additional product in advanced pre-clinical development for the treatment of heart disease. Gamida Cell's technologies are simple, reversible, do not involve genetic interference, and are easily scalable. For additional information please visit: www.gamida-cell.com. To schedule an interview, please contact Marjie Hadad, Media Liaison at marjie@gamida-cell.com or at +972-54-536-5220.


Source: Gamida Cell

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