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tsingtao2008

木虫 (著名写手)

地球村村民

应助: 48 (小学生)
金币: 472.6
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在线: 746.2小时
虫号: 90531
注册: 2005-09-02
性别: GG
专业: 植物遗传学

[交流] Old drug found new use

Study: Bayer drug helps liver cancer patients

Kidney cancer drug Nexavar could add months of life to liver cancer patients; if FDA-approved, developers Onyx, Bayer say it would be the first drug to successfully prolong patients' lives.
By Aaron Smith, CNNMoney.com staff writer
June 4 2007: 11:51 AM EDT

CHICAGO (CNNMoney.com) -- Nexavar, an approved kidney cancer drug developed by Onyx Pharmaceuticals and Bayer AG, is also effective in prolonging the survival of liver cancer patients, according to a new study.

Liver cancer patients taking the pill Nexavar outlived patients who did not take the drug by nearly three months, according to late-stage study results announced Monday at the annual conference of the American Society for Clinical Oncology.

Onyx's stock rose 6 percent on the news.

That study focused on 602 liver cancer patients around the world. Patients who took Nexavar survived an average of 10.7 months, compared to placebo patients, who lived for an average of 7.9 months.

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Emeryville, Calif.-based Onyx (Charts) and Germany's Bayer (Charts) are preparing to submit applications to the Food and Drug Administration and European regulators for approval to market Nexavar as a liver cancer drug.

If successful, the companies said, Nexavar, would be the first effective treatment in prolonging the life spans of liver cancer patients.

Hollings Renton, chief executive of Onxy, told CNNMoney.com that he hopes to have Nexavar FDA-approved as a liver cancer drug by early 2008.

"We would like to say we're curing cancer but that's not what's happening today," said Renton. "We are looking to turn cancer into more of a chronic disease so that patients can live longer with their disease and have a better quality of life."

A researcher in the study, Dr. Josep Llovet of the Barcelona Liver Cancer Group and the Mount Sinai School of Medicine, said the "unprecedented" study results support Nexavar's use as a new "standard of care" for previously untreated liver cancer patients. Llovet said there are no other drugs that significantly prolong life patients with this type of cancer.

Charles Duncan, analyst for the investment research firm JMP Securities, said the study results could help to boost annual Nexavar sales by about $750 million, in a best-case scenario. But that partly depends on the drug's ability to compete with other cancer drugs, like Genentech's Avastin and Pfizer's Sutent, said Duncan.

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Nexavar is also being studied as a potential treatment for lung and breast cancer and melanoma.

The partners Onyx and Bayer released Nexavar as a kidney cancer drug in the U.S. and Europe in 2006. In its first year on the market, Nexavar revenues came to $165 million. Sales in the first quarter of 2007 exceeded $60 million.

Unlike Bayer with its market cap of more than $55 billion, Onyx is a relatively small company with a market cap of $1.4 billion that is losing money. Because Nexavar is Onyx's sole product, expanding its use to other forms of cancer is critical.

Duncan does not have a formal recommendation for Onyx, and he has no investment relationship with the company.

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Bayer,Onyx liver cancer drug extends life 3 months
04 Jun 2007 12:12:54 GMT
Source: Reuters

(New throughout, updates with share price, background, analyst rating change)

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 and its U.S. partner Onyx Pharmaceuticals , 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)

据http://blog.muchong.com/html/05/80605-21524.html 说, Ｎｅｘａｖａｒ就是多吉美（索拉非尼、甲苯磺酸索拉非尼（sorafenibtosylate））, 是首个获准上市的多靶点靶向治疗药物，同时也是近十多年来惟一被ＦＤＡ批准用于治疗肾癌的新药，它的出现是肾癌治疗领域中的一个重大进展。索拉非尼（拜耳／Ｏｎｙｘ公司）的上市申请于２００５年１２月２０日获得ＦＤＡ批准。规格：200mg*60片/盒。价格2万5。

太贵了！

[ Last edited by tsingtao2008 on 2007-6-6 at 20:58 ]

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