Source:Â Sigilon press release
Sigilon Therapeutics, Inc., a biotechnology company that seeks to develop functional cures for chronic diseases through its Shielded Living Therapeutics™ platform, 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 clinical hold by the FDA in July 2021 following Sigilon’s submission of 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. These findings may have an impact on the timing of initiating dosing of patients in its planned Phase 1/2 clinical trial of SIG-005 for mucopolysaccharidosis typeÂ I (MPS-1).
“Patients’ safety and welfare are our highest priority. We are gathering information in order to understand these observations,” said Rogerio Vivaldi, M.D., President and CEO of Sigilon. “We will be working closely with the FDA, other regulators, and advisors to determine the impact of these observations on our programs.”
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.