Sigilon Therapeutics Inc (NASDAQ:SGTX) reported that fibrosed spheres were observed during a retrieval procedure in a patient in its Phase 1/2 study of SIG-001 in severe or moderately severe hemophilia A.
- The SIG-001 trial had been placed on FDA clinical hold following a serious adverse event report relating to the development of inhibitors to Factor VIII in one of three patients treated.
- This patient underwent a laparoscopic procedure prescribed by the investigator to retrieve implanted spheres.
- Upon inspection, it was determined that the spheres placed in the patient had fibrosed and that cells within the spheres were no longer viable.
- While the Company investigates the fibrosed spheres in this patient, all three patients enrolled in the SIG-001 trial will continue to be followed per study protocol.
- After these findings, Sigilon expects an impact on the timing of initiating dosing of patients in its planned Phase 1/2 clinical trial of SIG-005 for mucopolysaccharidosis type I (MPS-1).
- The status of Sigilon’s clinical hold investigation, including these findings, will be reviewed by the Safety Review Committee for SIG-001 at its next meeting in December.
- Price Action: SGTX shares are down 1.27% at $3.90 during the market session on the last check Monday.
