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发表于 2007-6-6 20:22:41
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Bayer,Onyx liver cancer drug extends life 3 months
04 Jun 2007 12:12:54 GMT
Source: Reuters
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By Kim Dixon
CHICAGO, June 4 (Reuters) - A drug already used to treat kidney cancer became the first medicine to extend the life of patients with advanced liver cancer in a clinical trial, adding about three months to survival compared to a placebo, according to a study released on Monday.
The trial found the biotechnology drug Nexavar, by German drugmaker Bayer AG <BAYG.DE> and its U.S. partner Onyx Pharmaceuticals <ONXX.O>, extended survival by 10.7 months, compared with 7.9 months for those on a placebo -- a 44 percent survival benefit -- sending Onyx shares about 10 percent higher in pre-market trading.
"Of about 100 trials in liver cancer in 30 years, all have been negative. There is an unmet need," said Joseph Llovet, director of liver cancer research at Mount Sinai School of Medicine in New York, who led the trial.
Liver cancer kills 622,000 people globally each year and is treated with a mix of surgery, radiation and chemotherapy. But there are no effective treatments when these aggressive options fail, and Bayer and Onyx hope to be first to fill that treatment gap.
Because of the survival advantage, the 600-person study was halted early so that all patients taking part could receive the drug, taken in pill form.
The result led Bear Stearns to raise its rating on Onyx shares to "outperform" from "peer perform," according to theflyonthewall.com.
The liver cancer data on Nexavar, among a new wave of treatments targeting cell receptors to block cancer growth, were presented at the American Society of Clinical Oncology's annual meeting in Chicago, where tens of thousands of cancer experts are gathering.
Although relatively uncommon in the United States, liver cancer is the third biggest cause of cancer deaths worldwide, largely due to the high incidence of hepatitis abroad that can lead to liver cancer, according to the World Health Organization.
Nexavar, known generically as sorafenib, is being tested against several types of cancer.
Bayer plans to submit its full applications seeking approval to sell the drug for liver cancer with U.S. and European regulators this summer, according to a spokesman.
The data presented at this meeting will likely lead to increased off-label use of the drug for liver cancer by doctors even before it is approved for that indication. The companies however cannot promote the medicine for that use until it gains official regulatory approval.
Liver cancer is primarily caused by exposure to the hepatitis B and C viruses, which can occur through sharing dirty needles, unprotected sex, in childbirth and from blood transfusions. Alcohol and smoking are also risk factors.
Once the virus is acquired, it can take several decades to develop into cancer. The disease is spreading at varying rates throughout the world because of the timing of exposure of different populations.
For example, in Japan, a public campaign to vaccinate for tuberculosis in the middle of the last century inadvertently spread the virus via unsanitary injection needles, Mount Sinai's Llovet said.
Rates in Japan are still high but have leveled off, while in the United States the virus began spreading quickly in the 1970s with increasing use of illicit drugs with hypodermic needles, he said.
In the United States, liver cancer kills about 17,000 people annually, but the rate is growing faster than in many other countries.
Onyx shares jumped about 10 percent in pre-market electronic trading to $34 from their $30.88 Nasdaq close on Friday. Bayer shares were little changed in Germany. (Additional reporting by Bill Berkrot in New York) |
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