CAMBRIDGE, MA, USA I July 09, 2021 I Sigilon Therapeutics, Inc. (NASDAQ:SGTX), a biotechnology company that seeks to develop functional cures for chronic diseases through its Shielded Living Therapeutics™ platform, today reported that the U.S. Food and Drug Administration (FDA) has notified the Company that its Phase 1/2 study of SIG-001 in patients with severe or moderately severe hemophilia A, has been placed on clinical hold. The clinical hold was initiated following the Company’s submission of a serious adverse event (SAE) and temporary enrollment halt to the FDA and other regulatory agencies.
To date, three patients have been dosed with SIG-001. The third patient, who received the highest dose of study drug, developed inhibitors to Factor VIII (FVIII) — a well-known complication of FVIII therapy. The patient is responding well to medical treatment and his condition continues to improve. Among other things, the FDA has requested additional information or data on factors potentially contributing to the development of inhibitors in this patient, such as family history and immune stimulation from a recent vaccination. All three patients enrolled in this study will continue to be followed per study protocol, while the company investigates the SAE.
“Patient safety is our top priority, and we are encouraged that the patient is recovering,” said Rogerio Vivaldi, M.D., President and CEO of Sigilon. “In collaboration with the regulatory agencies and our advisors, we are conducting a thorough investigation of this event to confirm whether there was a causal relationship between the development of inhibitors and SIG-001. We are committed to working with the FDA to resolve the clinical hold.”
The status of the SAE investigation will continue to be reviewed by the Safety Review Committee for SIG-001 and Sigilon will provide additional data when available.
About Sigilon Therapeutics
Sigilon Therapeutics seeks to develop functional cures for chronic diseases through its Shielded Living Therapeutics™ platform. Sigilon’s product candidates are non-viral engineered cell-based therapies designed to produce the crucial proteins, enzymes or factors needed by patients living with chronic diseases such as hemophilia, lysosomal diseases and diabetes. The engineered cells are protected by Sigilon’s Afibromer™ biomaterials matrix, which shields them from immune rejection and fibrosis. Sigilon was founded by Flagship Pioneering in conjunction with Daniel Anderson, Ph.D., and Robert Langer, Sc.D., of the Massachusetts Institute of Technology.
SOURCE: Sigilon Therapeutics
Post Views: 21
CAMBRIDGE, MA, USA I July 09, 2021 I Sigilon Therapeutics, Inc. (NASDAQ:SGTX), a biotechnology company that seeks to develop functional cures for chronic diseases through its Shielded Living Therapeutics™ platform, today reported that the U.S. Food and Drug Administration (FDA) has notified the Company that its Phase 1/2 study of SIG-001 in patients with severe or moderately severe hemophilia A, has been placed on clinical hold. The clinical hold was initiated following the Company’s submission of a serious adverse event (SAE) and temporary enrollment halt to the FDA and other regulatory agencies.
To date, three patients have been dosed with SIG-001. The third patient, who received the highest dose of study drug, developed inhibitors to Factor VIII (FVIII) — a well-known complication of FVIII therapy. The patient is responding well to medical treatment and his condition continues to improve. Among other things, the FDA has requested additional information or data on factors potentially contributing to the development of inhibitors in this patient, such as family history and immune stimulation from a recent vaccination. All three patients enrolled in this study will continue to be followed per study protocol, while the company investigates the SAE.
“Patient safety is our top priority, and we are encouraged that the patient is recovering,” said Rogerio Vivaldi, M.D., President and CEO of Sigilon. “In collaboration with the regulatory agencies and our advisors, we are conducting a thorough investigation of this event to confirm whether there was a causal relationship between the development of inhibitors and SIG-001. We are committed to working with the FDA to resolve the clinical hold.”
The status of the SAE investigation will continue to be reviewed by the Safety Review Committee for SIG-001 and Sigilon will provide additional data when available.
About Sigilon Therapeutics
Sigilon Therapeutics seeks to develop functional cures for chronic diseases through its Shielded Living Therapeutics™ platform. Sigilon’s product candidates are non-viral engineered cell-based therapies designed to produce the crucial proteins, enzymes or factors needed by patients living with chronic diseases such as hemophilia, lysosomal diseases and diabetes. The engineered cells are protected by Sigilon’s Afibromer™ biomaterials matrix, which shields them from immune rejection and fibrosis. Sigilon was founded by Flagship Pioneering in conjunction with Daniel Anderson, Ph.D., and Robert Langer, Sc.D., of the Massachusetts Institute of Technology.
SOURCE: Sigilon Therapeutics
Post Views: 21
