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> 聽說有人去追DNDN, 一天可以狂跌60%的股票....
raylin0107
張貼文章 06-06 2007, 03:56
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Promising cancer drug awaits OK from FDA

Kenneth Agnor, 73, who has lived with cancer since 1992, attributes his survival to clinical trials. One of the treatments was with the drug Provenge, designed to activate the body’s immune system by targeting cancers as if they were germs. VICKI CRONIS/THE VIRGINIAN-PILOT


By NANCY YOUNG, The Virginian-Pilot
© May 29, 2007



Kenneth Agnor knows why he's alive today.

"Quite a few times they'd say, 'We're going to try another type of treatment,' " said Agnor, a 73-year-old Chesapeake resident who was first diagnosed with prostate cancer in 1992. "I'm 100 percent sure that's what's kept me going all this time, the research medicine."

One of those treatments was a clinical trial for a drug called Provenge. The drug, which could change how some cancers are treated, is designed to activate the body's immune system by targeting cancers as if they were germs.

The Food and Drug Administration had been scheduled to vote earlier this month on whether to approve the drug for widespread use in men with advanced prostate cancer. Provenge had received a strong recommendation from an FDA advisory panel in March; usually the full agency follows suit.

Instead, Provenge is in a holding pattern. A week before its scheduled vote, the FDA told the drug's maker, Seattle-based Dendreon Corp., that it needs more clinical data on the drug's effectiveness. That will delay the FDA's decision on the drug until at least next year.

"It's a story of hope and hype followed by discouragement and depression," said Dr. Paul Schellhammer, a Norfolk urologist. He oversaw the treatment of more than 30 local patients on Provenge in clinical trials several years ago and now has patients in a third study that the FDA will use to inform its decision. Schellhammer said he had been paid in the past by Dendreon for serving as an advise r.

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The FDA's postponement has been criticized by advocacy groups for prostate cancer patients. But the agency's move is understandable, said Dr. Mark Fleming, a medical oncologist at Virginia Oncology Associates, which also is participating in the ongoing trial of Provenge.

There are "many stories in the history of cancer care" in which a promising treatment was approved prematurely "and it doesn't turn out to be effective," said Fleming, who specializes in prostate cancer. He added that there are other treatments that weren't available even a couple of years ago that have been proven to be effective.

Provenge is the commercial name for sipuleucel-T. Patients in the drug trials have their white blood cells - which serve in the body's immune system - extracted and exposed to Provenge in a lab. There, the aim is for the drug to essentially train those cells to target a protein associated with prostate cancer. The treated cells are then returned to the body in hopes of creating an immune response to stop the spread of the disease, whenever and wherever it might appear.

Provenge has been referred to as a cancer vaccine, and it would be one of the first such drugs authorized by the FDA if it wins approval.

The first two clinical trials indicated that Provenge helped extend the lives of patients who had a type of cancer that's usually not responsive to conventional hormone treatments. Three years after treatment in the first trial, 34 percent of men who had been given Provenge - 28 out of 82 - were still alive compared with 11 percent - five out of 45 - of those given a placebo.

"When a drug improves survival, it's a hallelujah event," Schellhammer said. He said he has patients who were treated with Provenge "who are still alive with minimal other therapies, which just defies the odds."

And, the treatment seemed to be especially patient-friendly, Schellhammer said, with little of the harshness of some chemotherapy drugs.

"No patient withdrew because of the side effects, which is virtually unheard of in an advanced cancer treatment trial," said Schellhammer, who is director of the Virginia Prostate Center at Eastern Virginia Medical School and incoming president of American Urological Association.

Though the results were encouraging, there was a catch.

The initial clinical trials were small - including about 220 men - and had some design problems.

The trials were set up to measure things such as whether the drug reduced tumors or eased cancer-related pain. They weren't specifically designed to determine if people treated with Provenge lived longer; that created concerns that the statistics on survival could be flawed in some way.

Schellhammer said he wouldn't have been surprised if those problems were stumbling blocks for the FDA 17-member advisory panel. Instead, the group voted in March that the evidence indicated Provenge was safe and effective. That seemed to set the stage for imminent approval by the FDA, and Dendreon's stock price shot up as the company began preparing for commercial production.

The market for a drug like Provenge is potentially huge. Prostate cancer is the second-leading cancer killer among American men - after lung cancer - killing about 30,000 men a year, according to the American Cancer Society.

With news of the delay, Dendreon's stock price plummeted. There have been fears that the company, which also has a breast cancer immunotherapy drug in an earlier stage of development, will not survive. Dendreon officials have said the company can withstand a delay into next year, when they believe results from the ongoing clinical trial will persuade the FDA to approve Provenge.

Advocates for patients with advanced prostate cancer say the wait will be tough.

"I don't think it's a total answer, but it's better than what we have," said Lewis Bellinger, who runs a support group at Sentara Norfolk General Hospital as a part of Us Too, an international, nonprofit organization that focuses on prostate cancer. He said some members have prostate cancer that has been resistant to other therapies.

"I say let's try anything and everything because there's really nothing else left," Bellinger said. "Let's face it, the alternative is to wait and die."

The key with prostate cancer is educating men that if it it's caught early, treatment is usually effective, Bellinger said. According to the American Cancer Society, the five-year survival rate of men who were diagnosed when the cancer was confined to the prostate or the immediate area is nearly 100 percent; once it has spread, it's 34 percent.

"You can't be lazy in learning what you need to do," said Bellinger, who is a prostate cancer survivor.

Agnor, a retired shipyard worker, admits he waited too long to get checked out in the first place. "I knew there was something wrong, but I'm like most normal people," said Agnor, who has cancer in several parts of his body. "I just kept putting it off, putting it off, putting it off."

Then the doctor sat him down and said, "'You've got cancer.' Scared me so bad."

"With the good Lord and the research people," Agnor said, "I know that's why I'm still here."



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raylin0107
張貼文章 06-06 2007, 04:00
發表於: #32


MoneyQ 首任海外事務部長
**********

所屬群組: 站務管理群組
發表總數: 4705
註冊日期: 02-19-2006
來自: Taipei
會員編號: 34




Dendreon Announces FDA Confirms Data Required for Provenge® Licensure
2007年5月31日, 下午 02:00:00
Dendreon Corporation announced the Company has received confirmation that the U.S. Food and Drug Administration (FDA) will accept either a positive interim or final analysis of survival from its ongoing IMPACT study to amend the Biologics License Application (BLA) for PROVENGE (sipuleucel-T). This information was obtained in a recent follow up meeting with the FDA to discuss the additional clinical data required to support the licensure of PROVENGE requested by the FDA in the Complete Response Letter the Company received on May 8, 2007.


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