CRISPR Ther­a­peu­tics, Ver­tex set for first sick­le cell dis­ease tri­al af­ter FDA lifts clin­i­cal hold — just don't look for any ex­pla­na­tion

CRISPR Ther­a­peu­tics and Ver­tex have re­solved a clin­i­cal hold on a high-pro­file gene edit­ing pro­gram — but they’re still not ready to di­vulge much in the way of de­tails about the tem­po­rary de­rail­ment they got slapped with five months ago.

The part­ners say the FDA has now giv­en the green light to test their sick­le cell dis­ease treat­ment in hu­mans. That will like­ly ex­pand the Phase I/II study the com­pa­nies are on track to ini­ti­ate by the end of the year, adding to sites in the UK and Cana­da, where they have se­cured clin­i­cal tri­al ap­provals.

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