Sigilon Therapeutics Announces Clinical Hold on SIG-001 Phase 1/2 Study in Hemophilia A
The clinical hold was initiated following the Companys submission of a serious adverse event (SAE) and temporary enrollment halt to the FDA and other regulatory agencies.
- The clinical hold was initiated following the Companys submission of a serious adverse event (SAE) and temporary enrollment halt to the FDA and other regulatory agencies.
- The third patient, who received the highest dose of study drug, developed inhibitors to Factor VIII (FVIII) a well-known complication of FVIII therapy.
- All three patients enrolled in this study will continue to be followed per study protocol, while the company investigates the SAE.
- Sigilon Therapeutics seeks to develop functional cures for chronic diseases through its Shielded Living Therapeutics platform.