SGTX - Sigilon cites impact on a future trial after fibrosed spheres found in hemophilia study

Having observed fibrosed spheres in a patient who underwent its Phase 1/2 study of SIG-001 in hemophilia A, Sigilon Therapeutics (NASDAQ:SGTX) says that the findings could have an impact on the timing of the start of dosing in a future Phase 1/2 trial of SIG-005 in mucopolysaccharidosis type I. Previously, the FDA had placed a clinical hold on the Phase 1/2 study for SIG-001 in severe or moderately severe hemophilia A after one of the three patients in the trial developed a serious adverse event. After a laparoscopic procedure performed to retrieve implanted spheres, it was found that the spheres had fibrosed and cells within them were not viable. The findings and the status of the clinical hold for SIG-001 will be the subject of a meeting by the Safety Review Committee in December, the company added. Read on the reasons for the clinical hold imposed by the FDA SIG-001 study in

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Sigilon cites impact on a future trial after fibrosed spheres found in hemophilia study