Updated Mon. Sep. 25 2006 8:18 AM ET
CTV.ca News Staff
A revolutionary anti-tumour drug in China is attracting terminally ill cancer patients from around the world, including Canada.
The world’s first “gene therapy” drug, named Gendicine, was officially licensed by the Chinese government in late 2003 after clinical trials found it noticeably improved the survival rate of patients with head and neck cancer, which are common in China.
Injected directly into the tumour, Gendicine is designed to destroy cancerous genes. The key ingredient is the p53 gene, described as a tumour-suppressing gene and which is mixed with a common virus.
Although Western regulators have yet to approve the therapy, some cancer patients in North America are willing to take the risk.
“Initially, there were concerns, but I’m into the treatment now, and I’ll see it through to the end,” British Columbia resident Terry McKenzie told CTV News.
McKenzie has travelled to Beijing’s Haidian Hospital, a cancer clinic located in the heart of the city’s university district, where specialists have injected Gendicine into a tumour in his liver. He also received a host of other drugs, including Endostar, which cuts off the blood supply to his tumours.
Like Gendicine, Endostar is another drug that is only currently available in China, although a related drug, Avastin, is on the market in North America.
Patients who come to the clinic can also receive standard treatments, like chemotherapy.
The clinic’s Director, Dr. Li Dingguang, who spent five years at Johns Hopkins University in the United States, refers to this as a “kitchen sink” approach. “More therapies better results, longer life for the cancer patients,” was how he put it.
Experts openly question the Chinese government’s willingness to approve new cancer drugs that are still in their experimental stages in North America.
As one Wall Street Journal article on Endostar noted: “The hurdles to getting Endostar approved for general use in the U.S. are high. It has only been tested in China, and it’s not clear whether those trials meet U.S. and European standards. The results of the trials have yet to be published in any Western peer-reviewed medical journals. The exact mechanism by which Endostar inhibits tumors from building a blood supply is unknown.”
Gene therapy researcher Dr. Jeffrey Medin questioned the whole “kitchen sink” philosophy, saying: “We’re not really sure what are the combined effects of some of these things. So, in theory, these things could be positive but they could also have negative consequences.”
Li Dingguang refused to elaborate on how effective the procedures are — even though the hospital charges tens of thousands of dollars for the treatment.
But for McKenzie, who is now able to eat and drink without pain, the prospect of other treatments is proving hard to resist.
“It’s given me tremendous hope, tremendous,” he said.
Where there’s hope, there’s opportunity. Business Week magazine reported that China’s State Council decided last spring to essentially double research and development spending. Within that, biotechnology has been designated a priority area.
Some Chinese scientists say clinical trials cost only about one-tenth of what they do in North America, and the overall regulatory climate is more favourable in their country. The more freewheeling environment is tweaking the interest of some American researchers.
Boldness in medicine, however, can come with a cost. The U.S. Food and Drug Administration shut down some gene therapy trials after one patient died in 1999 and others developed cancers as a result of their treatments.
With a report by CTV’s Steve Chao
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