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In patients with drug-resistant prostate cancer, new drug extendssurvival - Digital Camera Neck Str by
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In patients with drug-resistant prostate cancer, new drug extendssurvival - Digital Camera Neck Str

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"The reduction in mortality in this phase III study was higher thanwe had anticipated," said Scher. "This drug is prolonging survivalin patients with a particularly hard-to-treat cancer." Scher added: "As a clinical scientist who's own research is focusedon prostate cancer drug development, having the opportunity tofollow the science and then lead the development of the drug fromthe treatment of the first patient through the end of phase III hasbeen one of the most satisfying and exhilarating experiences in mycareer." Each year more than 210,000 new cases of prostate cancer arediagnosed in the United States. Male hormones (androgens) spurgrowth of prostate cancer cells. Current therapy for advancedprostate cancer involves treatment with drugs that block theandrogen receptor. Anti-androgen drugs, such as bicalutamide,suppress the growth of cancer cells temporarily, but patients withadvanced cancer eventually develop resistance to such drugs.

About32,000 men in the United States die each year from the disease. An Academic Path to Drug Discovery In the mid-1990s, Sawyers, who was then at UCLA, decided to studyhow androgen receptors stoke the growth of prostate cancer and whymen on hormone therapy ultimately relapse. Sawyers says that atthat time, the prevailing notion was that the androgen receptor hadnothing to with driving progression of advanced prostate cancer. In Sawyers' mind it was absolutely critical to understand ifandrogen receptor activity drove the disease.

But in the mid-1990s,scientists did not have the research tools to answer these criticalquestions. For example, researchers did not have the tumor samplesthey needed for such studies. "In an ideal world, we would examinematerial from patients who are in the early stages of theirtreatment and from those at the late stages," Sawyers said. "That'show we discovered Gleevec resistance. In prostate cancer, that's anon-starter.

The tissues are just not available." Sawyers notesthat it's technically challenging to try to isolate such tumorsamples from patients with advanced prostate cancer because thetumor usually spreads into the bone. So Sawyers' lab first spent time developing mouse models ofadvanced prostate cancer. In the mid-1990s, his team isolatedprostate tumors from human patients and grew the tumors in mice.They used the mice to study how prostate tumors responded to thepresence or absence of androgen hormones. "We learned severalimportant things by studying those mice," Sawyers said.

"We couldsee that the tumors grew better in male mice. And we could see thatif you castrated the male mice, the tumors stopped growing orshrunk. But within a month or two, they would grow back." Most importantly, the mice become a tool to unravel the cause ofresistance to hormone therapy. In 2004, Sawyers' team reported thatresistance was caused by a rejuvenated androgen receptor. The teamshowed that some men with advanced prostate cancer become resistantto hormone therapy because the tumors actually increase productionof androgen receptors.

Sawyers became convinced that blocking theandrogen receptor might be a viable treatment for prostate cancereven at this late stage of the disease. Despite the data emergingfrom his lab, he was greeted with skepticism from his contacts inthe pharmaceutical industry. No one in pharma seemed interested ingiving the idea a try, Sawyers said. "Developing new hormonereceptor therapy for prostate cancer was just not on anyone's radaranymore," he said.

Sawyers had a decision to make. "I knew if we didn't do something,the idea was just going to sit," he said. "Why Don't We Do This?" Before leading his lab on a leap into the unknown, Sawyers had aseries of discussions with his research team about what their nextsteps should be. Should Sawyers continue to try to interest pharmaor should the lab take on the drug discovery project? Sawyersrecalls that Charlie Chen and Derek Welsbie -- his two trainees whoconducted the mouse studies -- came to him and said, 'Why don't wedo this?'" Sawyers was initially skeptical and responded: "Becausewe don't know how.

This is pharma's territory. We don't know whatwe're doing." Sawyers said his skepticism stemmed, in part, from his firsthandexperience in understanding how pharmaceutical companies approachedcancer drug development. He played a key role in the development oftwo drugs for chronic myeloid leukemia, Gleevec and Sprycel , for which he shared the 2009 Lasker-DeBakey Clinical MedicalResearch Award. Ultimately, Sawyers' experience in chronic myeloid leukemia andbelief in what the biology was telling him led to his decision tomount a drug discovery effort in his lab.

The goal was bold:Attempt to design a new generation of drugs that could block theandrogen receptor where current versions of these drugs no longerworked. Sawyers knew his HHMI funding would cover the early costs of theresearch - he could start the project right away without having toask permission or write a grant application. One of his key earlydecisions was to ask UCLA synthetic chemist Michael Jung to jointhe project. "Finding Michael was absolutely key," Sawyers said.Although Jung had never developed a drug himself, he hadsynthesized some estrogen receptor compounds and was willing togive it a shot.

"I think neither of us thought it would go veryfar," Sawyers said. Jung scoured the patent literature for chemical compounds thatcould bind to androgen receptors. Jung noted that bicalutamide - acurrent drug for prostate cancer - actually bound the androgenreceptor rather weakly. Furthermore, Jung found a patent that theFrench pharmaceutical company Roussel Uclaf had filed in the early1990s describing a chemical compound that bound to androgenreceptor about 100 times more strongly than bicalutamide. "Theproblem with that compound [RU59063] is that it stimulates - ratherthan inhibits - the androgen receptor," Sawyers said.

"That's whyit never went anywhere as a prostate cancer drug." Jung decided to use RU59063 as a chemical scaffold -- making aseries of chemical tweaks to try to convert it from an activator ofthe androgen receptor to an inhibitor. The researchers synthesizednearly 200 slightly different versions of the drug. They testedeach one in the lab on prostate cancer cells that had beenengineered to produce high levels of androgen receptor. Their screens yielded a few new molecules that showed promise --one of which became MDV3100. The MDV3100 compound bound tightly tothe androgen receptor and did not show the cancer-stimulatingeffect of bicalutamide and other current anti-androgen drugs.

Afterseveral more months of tinkering, the scientists improved thecompound to the point where it was readily absorbed into the bloodwhen taken orally and persisted in the bloodstream. In early 2005, the researchers tested the new drug's effectivenessin mice with tumors derived from drug-resistant human prostatecancer cells. MDV3100 caused dramatic shrinkage of tumors in themice. "At that point, I knew we had something.

We all did," Sawyerssaid. "The question became what do we do next?" Sawyers knew the next logical step was to try to move the compoundinto clinical trials, but that meant crossing the so-called "valleyof death." The term refers to the point in drug development where alarge infusion of cash is needed to move a compound from theresearch and development lab into the clinic. "At most academicresearch institutions, this is an untenable proposition," Sawyerssaid. "It's a tremendous step up in procedure, infrastructurerequirements and cash, typically several million dollars." Sawyers showed his group's data to several large pharmaceuticalcompanies - all of them passed. But the promising laboratorystudies did pique the curiosity of a much smaller biopharmaceuticalcompany, called Medivation.

Medivation CEO David Hung brought inhis team to scrutinize Sawyers' and Jung's lab notebooks, learningtheir procedures. They hired a lab to try to replicate the findings- which they did. Medivation licensed the compound for commercialdevelopment in 2005, and set up the clinical trials, initially atMSKCC and later expanded to other sites. Looking back over the last decade of work on MDV3100, Sawyers saysit's extremely gratifying now to see the drug helping to prolongthe lives of those with advanced prostate cancer.

He's stillfocused on the science. There's more to learn about how the drugworks and how it ultimately causes the tumors to shrink. "We'vebeen looking hard at those questions," he said. "One of the keyquestions we're trying to pin down is how does MDV3100 change thestructure of the androgen receptor once it is bound to it. We havea ways to go before we know the answer.

We also want to know howtumors might escape from MDV3100, so we can be ready with the nextdrug.".

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