Last reviewed · How we verify
p53 gene with surgery
A p53 gene therapy that restores wild-type p53 tumor suppressor function in cancer cells, typically administered intratumorally in combination with surgical resection.
A p53 gene therapy that restores wild-type p53 tumor suppressor function in cancer cells, typically administered intratumorally in combination with surgical resection. Used for Head and neck squamous cell carcinoma (in combination with surgery), Other solid tumors with p53 mutations (off-label use in some regions).
At a glance
| Generic name | p53 gene with surgery |
|---|---|
| Also known as | no other names |
| Sponsor | Shenzhen SiBiono GeneTech Co.,Ltd |
| Drug class | Gene therapy (p53 tumor suppressor) |
| Target | p53 (tumor protein p53) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
Mechanism of action
This is a gene therapy product (Gendicine) that delivers functional p53 gene into tumor cells to restore apoptosis and cell cycle arrest in p53-deficient cancers. When combined with surgery, it aims to reduce recurrence by targeting residual disease and preventing tumor progression. The p53 protein acts as a 'guardian of the genome,' inducing cell death in malignant cells that would otherwise evade standard therapies.
Approved indications
- Head and neck squamous cell carcinoma (in combination with surgery)
- Other solid tumors with p53 mutations (off-label use in some regions)
Common side effects
- Fever
- Local injection site reactions
- Transient elevation of liver enzymes
- Immune-related inflammatory responses
Key clinical trials
- Li-Fraumeni & TP53 (LiFT UP): Understanding and Progress
- Multiplex Mutation Detection Using Mass Spectrometry in Bladder Cancer
- Navtemadlin and Radiation Therapy in Treating Patients With Soft Tissue Sarcoma (PHASE1)
- Collecting and Storing Tissue From Young Patients With Cancer
- Gene Therapy in Treating Patients With Non-small Cell Lung Cancer That Cannot Be Surgically Removed (PHASE1)
- Biomarkers in Patients With Rectal Cancer Undergoing Chemotherapy and Radiation Therapy
- p53 and Response to Preoperative Radiotherapy for T2 and T3
- Phase II Study of Combined Temozolomide and SGT-53 for Treatment of Recurrent Glioblastoma (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- p53 gene with surgery CI brief — competitive landscape report
- p53 gene with surgery updates RSS · CI watch RSS
- Shenzhen SiBiono GeneTech Co.,Ltd portfolio CI