FDA suspends Sigilon’s hemophilia cell therapy clinical trials
- Paternal Microbiome Perturbations Impact Offspring Fitness
- New Report Casts Doubt on Maradona’s Cause of Death and Rocks Manslaughter Case
- Chinese academician unable to provide the exact source of liver transplants
- Early Biomarker for Multiple Sclerosis Development Identified Years in Advance
- Aspirin Found Ineffective in Improving Recurrence Risk or Survival Rate of Breast Cancer Patients
- Child Products from Aliexpess and Temu Contain Carcinogens 3026x Over Limit
FDA suspends Sigilon’s hemophilia cell therapy clinical trials due to safety issues
FDA suspends Sigilon’s hemophilia cell therapy clinical trials due to safety issues. A few days ago, the FDA suspended Sigilon Therapeutics’ clinical trials of encapsulated cell therapy for the treatment of hemophilia type A.
Sigilon Therapeutics developed the hemophilia type A cell therapy numbered SIG-001, which aims to restore the patient’s ability to produce coagulation factors. This therapy encapsulates the coagulation factor VIII-producing cells in a semi-permeable protective film. It protects it from the immune system and prevents scar tissue from forming around it, and continues to produce coagulation factor VIII.
However, in this clinical trial involving 3 hemophilia A patients, the patients who received the highest dose of treatment showed antibodies against coagulation factor VIII, which means that the patient’s own immune system treats it as a foreign substance. Attacked.
Sigilon said that the FDA has requested more information about the possible causes of patients’ antibodies, including their family history and recent vaccination status.
Sigilon’s technology platform
Sigilon’s R&D pipeline
Hemophilia gene therapy
For hemophilia, BioMarin and Roche subsidiary Spark Therapeutics are both conducting research on gene therapy. In 2017, the FDA suspended Sanofi’s hemophilia gene therapy clinical trials due to the death of a patient.
Among them, the most rapid progress is BioMarin. It is understood that BioMarin has submitted a marketing application for the AAV therapy to the European Medicines Agency and the US FDA.
Picture source: NEJM
~~~~End~~~~
(source:internet, reference only)
Disclaimer of medicaltrend.org
Important Note: The information provided is for informational purposes only and should not be considered as medical advice.