What does Gendicine consist of?
Recombinant human p53 adenovirus for injection, Gendicine® is a genetic engineering-modified, infectious recombinant human p53 adenovirus particle (rAd-p53). It is consisted of defective human adenovirus-5 and normal p53 tumor suppressor gene.
Is Gendicine approved by FDA?
Gendicine is the first gene therapy product approved for clinical use in humans. Gendicine is manufactured by Shenzhen SiBiono GeneTech. Gendicine was approved in 2003 by the Chinese State Food and Drug Administration to treat head and neck squamous cell carcinoma.
How does Gendicine work?
Peng: Upon intratumor injection, Gendicine binds to the coxsakie adenovirus receptor (CAR) on tumor cells. Subsequently, Gendicine enters tumor cells via receptor-mediated endocytosis and begins to over-express the encoded exogenous p53 gene. The over-expressed p53 protein triggers multiple tumor fighting functions.
What is p53 gene therapy?
Another experimental cancer therapy in development involves “patching” mutated p53 genes in cells so they can function normally again. Doctors could potentially use this medicine to treat cancer and prevent it by repairing defective p53 genes before cells have the chance to become cancerous.
What is the function of the protein p53?
A gene that makes a protein that is found inside the nucleus of cells and plays a key role in controlling cell division and cell death. Mutations (changes) in the p53 gene may cause cancer cells to grow and spread in the body.
What do most current gene therapy trials target?
The majority of gene therapies clinical trials identified targeted cancer diseases. Conclusion: The first gene therapy was approved in the European Union in 2012, after two decades of dashed expectations. This approval boosted the investment in developing gene therapies.
What are the disadvantages of gene therapy?
This technique presents the following risks: Unwanted immune system reaction. Your body’s immune system may see the newly introduced viruses as intruders and attack them. This may cause inflammation and, in severe cases, organ failure.
Where is gene therapy available?
Gene therapy is currently available primarily in a research setting. The U.S. Food and Drug Administration (FDA) has approved only a limited number of gene therapy products for sale in the United States.
How is gene therapy helpful in our body?
Gene therapy replaces a faulty gene or adds a new gene in an attempt to cure disease or improve your body’s ability to fight disease. Gene therapy holds promise for treating a wide range of diseases, such as cancer, cystic fibrosis, heart disease, diabetes, hemophilia and AIDS.
What does p53 do?
The p53 gene is one type of tumor suppressor gene. This gene codes for proteins that function as a safety net, preventing abnormal cells from developing into cancer cells.
What happens if the p53 gene mutates?
The p53 gene is one of the key rule-enforcers. It is known as a ‘tumor suppressor’ because it is important in killing cells that have become potentially cancerous. If the p53 gene gets a damaging mutation, then p53 will stop doing it’s job to protect you from cancer.
What is the function of p53 protein in a normal cell?
Primary information of p53 gene. As many as 50% of all human tumors contain p53 mutants. In normal cells, the p53 protein level is low. DNA damage and other stress signals may trigger the increase of p53 proteins, which have three major functions: growth arrest, DNA repair and apoptosis (cell death).
Does anyone know about the p53 gene?
The p53 gene (TP53) is a gene that is mutated in many cancers, and is the most common gene mutation found in cancer cells. The gene is a type of tumor suppressor gene that codes for a protein that inhibits the development and growth of tumors.