- 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.