BrainStorm busca  aprovação no Canadá para disponibilizar células-tronco adultas   NurOwn® para o tratamento da ELA
Autor: Antonio Jorge de Melo | Publicado: 2017-02-22T04:51:00-08:00

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TORONTO, HACKENSACK, N.J.&nbsp;and PETACH TIKVAH, Israel, Feb. 21, 2017 /PRNewswire. A
BrainStorm Cell Therapeutics Inc., uma &nbsp;das
principais desenvolvedores de tecnologias de &nbsp;células-tronco adultas para uso em doenças
neurodegenerativas, assinou um acordo com a CCRM(Centre for Commercialization of Regenerative Medicine), uma &nbsp;organização federal canadense &nbsp;sem
fins lucrativos com &nbsp;&nbsp;sede em
Toronto, lider &nbsp;&nbsp;no desenvolvimento e comercialização de
tecnologias de medicina regenerativa e terapias celulares e genéticas, que apoia o desenvolvimento de tecnologias
fundamentais que aceleram a comercialização de produtos e terapias baseados em
células-tronco e biomateriais, &nbsp;para apoiar o pedido de autorização para que a
&nbsp;NurOwn ® atue no mercado Canadense. Neste
momento, o CCRM está ajudando a Brainstorm a ter oportunidade de tratar pacientes
com Esclerose Lateral Amiotrófica (ELA). <span title="If NurOwn® qualifies for Health Canada's &quot;Notice of Compliance with Conditions&quot; pathway, it could be authorized in Canada for distribution in early 2018.

">Se
a NurOwn® conseguir &nbsp;se qualificar
através do órgão regulatório Canadense, ela poderá ser autorizada a atuar no &nbsp;Canadá no início de 2018.

<span title="If NurOwn® qualifies for Health Canada's &quot;Notice of Compliance with Conditions&quot; pathway, it could be authorized in Canada for distribution in early 2018.

">&nbsp;


"Estamos
satisfeitos em parceria com a CCRM enquanto continuamos nossos esforços para
desenvolver e disponibilizar o NurOwn® comercialmente aos pacientes com ELA o
mais rápido possível", diz Chaim Lebovits, presidente e CEO da BrainStorm.
"Estamos
ansiosos para discutir com os funcionários da Health Canada os resultados do
nosso programa clínico para a ELA, e queremos &nbsp;mostrar evidências convincentes de segurança e
eficácia para &nbsp;qualifica-lo &nbsp;numa revisão rápida sob as diretrizes regulatórias
do Canadá para medicamentos que tratam doenças graves ou potencialmente fatais."

"Os
assuntos regulatórios são uma parte essencial do processo de comercialização e
é por isso que a CCRM desenvolveu expertise interna para oferecer consultoria
aos nossos parceiros acadêmicos e da indústria", explica o Dr. Michael
May, presidente e CEO da CCRM. <span title="&quot;Patrick Bedford is working with BrainStorm to support its efforts to bring a treatment for ALS to patients in Canada.&quot;

">"Patrick
Bedford está trabalhando com BrainStorm para apoiar seus esforços para trazer esse
tratamento para a ELA aos pacientes no Canadá."

"O
Health Canada é um órgão de classe mundial que pode usar vias regulatórias
especiais para revisar dados de segurança e dados preliminares de eficácia para
autorizar terapias promissoras, enquanto aguarda a conclusão de estudos
confirmatórios de eficácia", disse Patrick Bedford, gerente de assuntos
regulatórios da CCRM. De
fato, a ELA foi identificada especificamente por Health Canada como uma
condição grave com necessidades clínicas não satisfeitas que pode se qualificar
para uma via regulatória especial. Se os dados existentes de ensaios
clínicos da BrainStorm forem suficientes, a tecnologia NurOwn® poderá ser disponibilizada
aos canadenses no próximo ano. <span title="&quot;

">"

<span title="&quot;

">&nbsp; 

<span title="&quot;

">Fonte:&nbsp; http://ir.brainstorm-cell.com/phoenix.zhtml?c=142287&amp;p=irol-newsArticle&amp;ID=2247581

<span title="&quot;

">Tradução: Google. Texto editado

<span title="&quot;

">&nbsp; 



<span title="About CCRM

">