Product Description
Gendicine (recombinant human p53 adenovirus), developed by Shenzhen SiBiono GeneTech Co. Ltd., was approved in 2003 by the China Food and Drug Administration (CFDA) as a first-in-class gene therapy product to treat head and neck cancer, and entered the commercial market in 2004. Gendicine is a biological therapy that is delivered via minimally invasive intratumoral injection, as well as by intracavity or intravascular infusion. (Sourced from: https://pubmed.ncbi.nlm.nih.gov/29338444/)
Mechanisms of Action: Gene Therapy, p53
Novel Mechanism: Yes
Modality: Gene Therapy
Route of Administration: Injection
FDA Designation: *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: Shenzhen SiBiono GeneTech
Company Location:
Company CEO:
Additional Commercial Interests: None
Clinical Description
Countries in Clinic:
Active Clinical Trial Count:
Recent & Upcoming Milestones
Highest Development Phases
Phase 4: Oncology Solid Tumor Unspecified
Phase 2: Hepatocellular Carcinoma|Head and Neck Cancer
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|
| ChiCTR2100052227 | N/A |
Not yet recruiting |
Nasopharyngeal Cancer |
2024-01-01 |
|||
| ChiCTR-TRC-08000092 | N/A |
Completed |
Nasopharyngeal Cancer |
2011-10-31 |
|||
| ChiCTR-TRC-08000091 | N/A |
Completed |
Cervical Cancer |
2010-02-01 |
|||
| ChiCTR-TRC-09000392 | N/A |
Completed |
Oncology Unspecified |
2008-06-30 |
|||
| rAd-p53-J1002 | P2 |
Unknown status |
Head and Neck Cancer |
2018-12-01 |
2019-03-20 |
Treatments |
|
| rAd-p53-H14006 | P2 |
Unknown status |
Hepatocellular Carcinoma |
2017-05-01 |
2019-03-20 |
Treatments |
|
| rAd-p53-003 | P4 |
Unknown status |
Oncology Solid Tumor Unspecified |
2012-08-01 |
2019-03-18 |
Treatments |