As Bob Langer biotech's lead cell ther­a­py re­mains on FDA hold, re­searchers find 'un­ex­pect­ed' fi­bro­sis

Back in Ju­ly, the FDA placed a clin­i­cal hold on the Bob Langer and Flag­ship-backed biotech Sig­ilon Ther­a­peu­tics for its lead pro­gram to treat he­mo­phil­ia A. On Mon­day, Sig­ilon re­port­ed an “un­ex­pect­ed” find­ing.

Af­ter a pa­tient in the three-per­son Phase I/II study re­port­ed a se­ri­ous ad­verse event, Sig­ilon dis­cov­ered the spheres used to de­liv­er the cell ther­a­py had fi­brosed af­ter con­duct­ing a la­paro­scop­ic pro­ce­dure, the biotech an­nounced Mon­day. As a re­sult, the treat­ment con­tained with­in the spheres was no longer vi­able af­ter the pa­tient de­vel­oped in­hibitors to Fac­tor VI­II.

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