Europe and the United States are probably still a year away from licensing gene therapy, however, there are currently at least two clinical trials testing gene therapy for mesothelioma. They include the University of Pennsylvania and the Louisiana State University. Unfortunately, gene therapy research took a big blow in 1999 when teenager Jesse Gelsinger died during a gene therapy clinical trial at the University of Pennsylvania.
Despite that, China is now the only country in the world that has already approved gene therapy. On October 16, 2003, the drug named Gendicine was approved by the State Food and Drug Administration of China. Gendicine had more than 5 years of clinical trials before it was approved. They have currently used this therapy on over 4500 patients and have followed their patient’s progress for over 6 years. Now, hundreds of cancer patients from around the world are travelling to Beijing to receive this leading edge treatment.
The clinical trials of Gendicine included 135 patients and results showed that 64% of patients showed tumour regression after 8 weekly injections in combination with radiation therapy. According to the clinical trial results, using Gendicine with chemotherapy and radiation therapy can improve the efficacy by 3 times. The only side effect of Gendicine is a typical overnight fever.
Since there are no other approved gene therapy treatments in the world, many desperate cancer patients from North America and Europe are travelling to Beijing, China to receive treatment of Gendicine.
Richard Weissenborn from Texas, USA, had tongue cancer that had spread to his lymph nodes and was given two months to live in July of 2006. He was treated with Gendicine and chemotherapy by Dr. Li Dinggang at the Haidan Hospital in Beijing at a cost of about $30,000 U.S.
After two cycles of treatments, over two months, a pet scan showed that he was cancer free. The controversy around this story is that even though Richard’s cancer was gone there are some doubts as to whether the chemotherapy or Gendicine cured it. Dr. Mark Persky, a cancer specialist remarked that “According to my review, there’s really no way of telling whether one or the other caused tumour regression”.
In a healthy cell, there is a gene called the p53 gene, which can repair DNA, arrest cell growth, and initiate a cellular self destruction if the cell damage is too great as in the case of cancer. However, in a study by the Chinese Academy of Preventive Medicine in Beijing, they found that there was a high occurrence of p53 gene damage in asbestos related cancers such as mesothelioma.
Gendicine works by reactivating the p53 gene, which acts as tumour suppressant but is shut off in a cancer cell because it may become deactivated by mutagens such as asbestos, chemicals and radiation. Gendicine treatment uses a virus as a medium to carry the p53 gene into the cancerous cells and causes the p53 gene to reactive and initiate self destruction (apoptosis) of the cancer cell.