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TNFerade biologic · 2 trials · 2 indications
| Name | Type | Description |
|---|---|---|
| TNFerade biologic | DRUG | - |
Inclusion Criteria: * Age 70 or older with an ECOG performance status 0-2,or * Patients \> 18 years of age with ECOG performance status of 2 or greater, or * Patients \> 18 years of age unsuitable for concurrent chemotherapy or surgery due to: * Renal failure, or * Severe cardiopulmonary disease, o...
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TNFerade biologic is an investigational therapy being studied for the treatment of Head and Neck Cancer. It is administered by injection in combination with radiotherapy and other agents, such as cetuximab or fluorouracil and hydroxyurea, in clinical trials. The drug is currently in Phase 1 clinical development and is not yet approved.
TNFerade biologic is a gene therapy that delivers the gene for tumor necrosis factor-alpha (TNF-alpha) directly into tumors. TNF-alpha is a cytokine that can induce tumor cell death and enhance the effects of radiation therapy. By producing TNF-alpha locally within the tumor, the therapy aims to increase the anti-tumor response.
TNFerade biologic is being developed by Precigen, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol PGEN. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational therapy in patients with Head and Neck Cancer.
TNFerade biologic is in Phase 1 clinical development. Two Phase 1 trials have been completed, both in patients with Head and Neck Cancer. The drug is investigational and has not been approved by regulatory authorities. Its safety and effectiveness are still being evaluated in early-stage clinical studies.
TNFerade biologic has been studied in two completed Phase 1 clinical trials. NCT00496236 evaluated the drug with radiotherapy and cetuximab in elderly or frail patients with Head and Neck Cancer. NCT00496535 studied TNFerade biologic with radiotherapy, fluorouracil, and hydroxyurea in patients with Head and Neck Cancer. Both trials were conducted in the United States.
TNFerade biologic is not the same as TNF-alpha. It is a gene therapy that encodes the TNF-alpha gene, causing tumor cells to produce TNF-alpha locally. This approach is designed to concentrate the cytokine's anti-tumor effects within the tumor microenvironment, potentially reducing systemic toxicity compared to direct TNF-alpha administration.