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rAd-p53 gene
rAd-p53 gene is a Gene therapy; oncolytic virus Small molecule drug developed by Shenzhen SiBiono GeneTech Co.,Ltd. It is currently FDA-approved for Head and neck squamous cell carcinoma, Lung cancer.
rAd-p53 is a recombinant adenovirus carrying the wild-type p53 tumor suppressor gene that restores p53 function in cancer cells to induce apoptosis and inhibit tumor growth.
The rAd-p53 gene is a form of gene therapy used to treat various conditions, including advanced malignant thyroid tumors, neoplasms, and advanced adult hepatocellular carcinoma, as per ClinicalTrials.gov. According to ChEMBL, the rAd-p53 gene is administered as a small molecule intervention.
At a glance
| Generic name | rAd-p53 gene |
|---|---|
| Sponsor | Shenzhen SiBiono GeneTech Co.,Ltd |
| Drug class | Gene therapy; oncolytic virus |
| Target | p53 tumor suppressor gene |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
Mechanism of action
This gene therapy delivers a functional copy of the p53 tumor suppressor gene via an adenoviral vector into cancer cells that have lost or mutated p53. Restoration of p53 function triggers apoptosis in malignant cells and restores cell cycle control. The approach is designed to overcome p53 deficiency, which is present in a majority of human cancers.
Approved indications
- Head and neck squamous cell carcinoma
- Lung cancer
Common side effects
- Fever
- Injection site reactions
- Flu-like symptoms
- Transient liver enzyme elevation
Key clinical trials
- Evaluation of the Diagnostic and Prognostic Role of PET (PET/CT and PET/MRI) in Gynecological Tumors.
- p53 Gene Therapy in Treatment of Diabetes Concurrent With Hepatocellular Carcinoma (PHASE2)
- Trans-catheter Arterial Embolization Combined With p53 Gene Therapy for Treatment of Advanced Hepatocellular Carcinoma (PHASE2)
- P53 Gene Combined With Radio- and Chemo-therapy in Treatment of Unresectable Locally Advanced Head and Neck Cancer (PHASE2)
- Trans-catheter Chemo-embolization Combined With rAd-p53 Gene Injection in Treatment of Advanced Hepatocellular Carcinoma (PHASE2)
- Surgery Combined With rAd-p53 Gene in Treatment Advanced Non-small-cell Carcinoma (PHASE2)
- rAd-p53 Gene Therapy for Advanced Malignant Thyroid Tumors (PHASE4)
- rAd-p53 Gene Therapy for Advanced Oral and Maxillofacial Malignant Tumors (PHASE4)
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:
- rAd-p53 gene CI brief — competitive landscape report
- rAd-p53 gene updates RSS · CI watch RSS
- Shenzhen SiBiono GeneTech Co.,Ltd portfolio CI
Frequently asked questions about rAd-p53 gene
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Related
- Drug class: All Gene therapy; oncolytic virus drugs
- Target: All drugs targeting p53 tumor suppressor gene
- Manufacturer: Shenzhen SiBiono GeneTech Co.,Ltd — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Head and neck squamous cell carcinoma
- Indication: Drugs for Lung cancer
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing