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European Medicines Agency (EMA) Waives Requirement to Test StemEx(R) in Paediatric Patients 17 Years of Age and Under
Date:1/18/2010

JERUSALEM, Israel, January 18 /PRNewswire/ --

- The International Study of StemEx, an Experimental Treatment for Leukemia, Lymphoma and MDS, is now Enrolling at Clinical Sites in Italy, Hungary, Spain, Israel and the U.S.

The Gamida Cell-Teva Joint Venture (JV) announced today that the Paediatric Committee (PDCO) of the EMA has granted product specific waivers for StemEx for all subsets of the paediatric population (birth to 17 years of age) in all conditions. The PDCO emphasized that the granting of the waivers should not prevent the JV from considering developing StemEx for children with conditions where there is a need. StemEx is being developed by a joint venture equally owned and operated by Gamida Cell and Teva Pharmaceuticals ( TEVA).

In order to register a new medicinal product in the European Union, a company generally needs to clinically prove efficacy and safety in paediatric patients in addition to adults. Moreover, a company has to submit to the PDCO a Paediatric Investigational Plan (PIP) for the four existing paediatric age subsets which cover from birth to 17 years of age. The JV submitted a PIP for the age group 12 -17 together with product specific waiver requests for the three age groups between birth to 11 years of age.

As the added value of StemEx lies primarily in the treatment of larger children and adult patients, the PDCO waiver is congruent with the JV's strategy to develop StemEx initially for adolescents and adults.

Ms. Michal Austin, director of regulatory affairs said, "It is well known that the limited number of stem cells in cord blood inhibits the therapeutic use of cord blood transplantati
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SOURCE Gamida Cell Ltd.
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