Sign in Subscribe
Genetic research

Saudi Arabia Approves First Local Clinical Study of Novel Gene Therapy for Aggressive Lymphoblastic Leukemia

Strategic Insights

— 1 min read

The Saudi Food and Drug Authority has approved the first phase 1 clinical study of a locally developed, novel gene therapy using engineered T-cells (CAR T-cells) to treat patients with aggressive lymphoblastic leukemia. The therapy was developed and manufactured locally within a research environment at King Faisal Specialist Hospital and Research Centre in Riyadh. This study marks a significant achievement for the Kingdom, demonstrating the integrated efforts between regulatory and research entities in developing advanced treatments within the Kingdom.

Key Takeaways:

  • The Saudi Food and Drug Authority has approved the first phase 1 clinical study of a locally developed, novel gene therapy using CAR T-cells for patients with aggressive lymphoblastic leukemia.
  • The therapy was developed and manufactured locally within a research environment at King Faisal Specialist Hospital and Research Centre in Riyadh.
  • The study aims to evaluate the safety of the treatment as a primary goal in this early phase.
  • The research treatment relies on modifying the patient's T cells outside the body to reprogram them to target tumor cells bearing the CD19 protein, then reinjecting them into the patient.
  • The study uses a closed-loop transport system to ensure the safety of the drug for patients aged 18 to 60, administered intravenously.
  • The development of this treatment is being overseen by a group of scientists and researchers at King Faisal Specialist Hospital and Research Centre in Riyadh, in collaboration with Lintgen/Melitoni.
  • The study is part of the Kingdom's efforts to develop advanced treatments and innovative research within the country, aligning with the objectives of the Health Sector Transformation Program, one of the programs of Vision 2030.

Statistics:

  • The study aims to evaluate the safety of the treatment, which is a key goal in this early stage.
  • The study uses a closed-loop transport system to ensure the safety of the drug for patients aged 18 to 60, administered intravenously.
  • The therapy was developed and manufactured locally within a research environment at King Faisal Specialist Hospital and Research Centre in Riyadh.
  • The study is expected to recruit patients with aggressive lymphoblastic leukemia who have relapsed or failed to respond to treatment.

Sources:

  • Saudi Food and Drug Authority [August 28]

Read more