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2011年01月30日
09:58
Studentさん

エーザイの乳がん新薬を承認へ 物質探しから25年

エーザイの乳がん新薬を承認へ 物質探しから25年
http://www.47news.jp/CN/201101/CN2011012001000622.html

 再発または手術不能な乳がんに対するエーザイの抗がん剤「ハラヴェン」(一般名エリブリンメシル酸塩)について、厚生労働省の医薬品第2部会は20日、製造販売を承認してよいとの意見をまとめた。上部の薬事分科会への報告を経て正式に承認される。

 エーザイによると、臨床試験で既存の治療法より患者の生存期間を2・5カ月延長。2~5分で注射でき外来治療にも向いているという。

 この薬につながる物質「ハリコンドリンB」は1985年、故平田義正名古屋大名誉教授らがクロイソカイメンから抽出し構造を特定。92年に米ハーバード大の岸義人名誉教授が人工合成に成功した後、エーザイが有効性の核となる部分を突き止め、薬として生産するための複雑な工程を確立した。

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2011年
01月30日
09:58
Studentさん

◯Rosegrowerさん:

固有名詞などはwsjの記事を参考にしました。
http://online.wsj.com/article/SB1000142405274870411150457...

1) 再発または手術不能な乳がんに対するエーザイの抗がん剤「ハラヴェン」(一般名エリブリンメシル酸塩)について、厚生労働省の医薬品第2部会は20日、製造販売を承認してよいとの意見をまとめた。上部の薬事分科会への報告を経て正式に承認される。

The forum of the Drug Medicine 2nd Department of Health, Labour and Welfare Ministry agreed on 20th Jan. to issue an approval on Eisai’s antitumor drug “Halaven” (nonproprietary name: eribulin methyl acid) that prevents recurrence of and fights against inoperable breast cancer for production and sales. The official approval will come through the reporting to the pharmaceutical meeting.

2)  エーザイによると、臨床試験で既存の治療法より患者の生存期間を2・5カ月延長。2~5分で注射でき外来治療にも向いているという。

According to Eisai Co. in the clinical tests the drug can extend patients’ life 2.5 months longer than the existing treatment. The treatment only requires a 2 to 5 minutes’ injection and is suitable for outpatients.

3)  この薬につながる物質「ハリコンドリンB」は1985年、故平田義正名古屋大名誉教授らがクロイソカイメンから抽出し構造を特定。92年に米ハーバード大の岸義人名誉教授が人工合成に成功した後、エーザイが有効性の核となる部分を突き止め、薬として生産するための複雑な工程を確立した。

The substance” halichondrin B” that was led to the drug was found in 1985 by late Dr. Yoshimasa Hirata, Nagoya University emeritus and others, and extracted from the black sponge (kuroiso kaimen). Then finally its structure was specified. After Dr. Yoshito Kishi, the Harvard emeritus succeeded in the synthesis in 1992, Eizai Co. pinpointed the core of the active constituents and then established the complex pharmaceutical production process.

2011年
01月30日
10:00
Studentさん

◯Rosieさん:

また別の言い方もということで、僭越ながらいくつかご提案させていただきたく存じます。

1)
for production and salesの位置をもう少し近くに置いた方が明瞭になるように思いますので、語順を変えてみてもよいかと思いました。あと「上部の」の訳が抜けているようです。upper levelでどうでしょう。

On January 20th, the forum of the Drug Medicine 2nd Department of Health, Labor and Welfare Ministry agreed to issue an approval for producing and selling the Eisai’s antitumor drug “Halaven” (nonproprietary name: eribulin methyl acid) that prevents recurrence of and fights against inoperable breast cancer. The official approval will come through the reporting to the upper-level pharmaceutical meeting.

2)
According to Eisai Co. in the clinical testsのところはdemonstratedも使えそうです。「治療法treatment」はmedicationも代用できると思います。

Eisai Co. demonstrated in the clinical tests that the drug could extend patients’ life by 2.5 months longer than the existing medication. The treatment only requires a 2 to 5 minutes’ injection and is suitable for outpatients.

3)
「この薬につながる物質」のところはもう少し短くできないかと思い、precursorを思いつきました。この場合ふさわしいかどうか今一つ自信がありませんが使ってみます。「突き止め」はidentifyも使えそうです。

※precursor: something that happened or existed before something else and influenced its development

The precursor of the drug, ” halichondrin B” was extracted from the black sponge (kuroiso kaimen) by late Dr. Yoshimasa Hirata, Nagoya University emeritus and others in 1985 and its structure was specified. After Dr. Yoshito Kishi, the Harvard emeritus succeeded in the synthesis in 1992, Eizai Co. identified the core of the active constituents and then established the complex pharmaceutical production process.

ほとんどRosegrowerさんの語句を拝借しました。またご意見をいただければと思います。

2011年
01月30日
10:02
Studentさん

◯Student‐t:

ウォールストリートジャーナルの参考記事はスグに有料サイトに移動され見れなくなったりするので、後のチェックのためにコピぺしておきます。よろしくお願いします。

New Breast Cancer Drug Found Deep in the Sea

By PETER LANDERS

Amid a dry spell for breakthrough cancer drugs, recent U.S. approval of Eisai Co.'s Halaven represents some vindication for a small group of researchers who believe, contrary to recent pharmaceutical fashion, that molecules from nature hold promise against hard-to-treat diseases.

The Food and Drug Administration's approval of Halaven in November for treating late-stage breast cancer was a triumph of chemistry and tenacious research. Its path, extending nearly three decades from the first studies, demonstrates not only potential benefits but also some of the hurdles in the hunt within nature's bounty for drugs of the future.

Primitive creatures developed many clever ways to kill each other after billions of years of evolution, and some can be turned to human use. "Weapons of mass destruction are alive and well on a coral reef," says David Newman of the National Cancer Institute, who has studied the subject for decades.

Halaven derives from halichondrin B, a substance identified in a black sponge that lives off the coast of Japan. Studies showed it has a powerful effect on tumors, blocking cell division in a way that scientists hadn't previously thought of.

Yoshito Kishi, a Harvard University chemistry professor, synthesized halichondrin B with funding from the National Cancer Institute. His work galvanized researchers at Eisai of Japan, who identified the active part of the molecule and, working with Dr. Kishi, went on to create the drug. Chemists say Halaven is among the most complex small-molecule drugs ever made commercially.

Dr. Kishi fears younger researchers are ignoring Halaven's lesson. Eisai Co., led by the founder's grandson since 1988, stuck with the Halaven research despite nearly dropping it more than once. "If the CEO changes every 10 years, then this type of project couldn't go through," Dr. Kishi says.

Big pharmaceutical companies used to have entire sections devoted to research on natural products, and they yielded some major anticancer drugs. Taxol, from the Pacific yew tree, is a staple chemotherapy drug; another set of widely used drugs derives from the Madagascar periwinkle plant. Yet despite popular notions about the miracle cures lying in the Amazon, many companies over the past decade have scaled back research into potential natural sources.

Recently, rather than start with nature, many corporate scientists have been starting with a target, the particular process in cancerous cells that goes awry. They look for drugs, typically synthetic or semi-synthetic molecules cooked up by humans, that can block the target process.

This type of search holds out hope of a cure, rather than simply extending life. Halaven, meanwhile, is no cure. A study found it extended the life of patients with advanced breast cancer by about two-and-1/2 months, to 13 months.

At first it was hard to gather enough of the sponge molecule for research, let alone for studies on animals. The National Cancer Institute in the 1990s teamed up with the government of New Zealand to harvest a ton of sponges just to get a few hundred milligrams.

Cancer drugs from nature tend to have nasty side effects. Typically they work by blocking cell division, using a chemical "weapon" that one bacterium or fungus may use against another. When these drugs work, they also harm healthy cells. And in the most difficult tumors, they may lose effectiveness, as cancerous cells develop resistance.

That's why research into targeted drugs is center stage at large companies. "Natural-products discovery is a small-company endeavor nowadays," says Ken Lloyd of Nereus Pharmaceuticals Inc., of San Diego, which is awaiting data from mid-stage trials of a lung-cancer drug derived from a marine fungus.

The fashion for targeted therapies also may have its blind spots. Some targeted therapies also offer only a few extra months of life. The best-known, Novartis AG's Gleevec, which went on the market in 2001, works by turning off the protein blamed for triggering chronic myeloid leukemia, a cancer of the blood and bone marrow. Gleevec has produced a nearly 90% five-year survival rate in patients, and 2010 sales were on track to top $4 billion.

But Gleevec is virtually alone among targeted therapies in delivering such dramatic outcomes. Hopes that deciphering the human genome would lead directly to cures have failed to pan out; billions of dollars in corporate research has produced a string of failures. In breast cancer, for example, Pfizer Inc.'s Sutent failed two big trials last March, showing serious side effects but no efficacy when added to chemotherapy.

In that light, Halaven's modest benefit looks meaningful. Eisai has said it hopes annual sales eventually top $1 billion. Much depends on whether Halaven proves valuable against earlier-stage disease, and on how well it works in combination therapies that are given the best odds of holding back cancer. Takashi Owa, head of Eisai's cancer unit, says Eisai wants to test it as a first-line therapy.

And don't assume natural products are doomed to modest efficacy compared with targeted drugs, Dr. Owa says. "Cytotoxic [cell-killing] agents in some cases can demonstrate unexpectedly remarkable clinical benefit," he says. A natural molecule, if screened properly, may prove to have the same qualities as a targeted drug—or even reveal previously unknown targets.

One popular drug target is "mammalian target of rapamycin" or mTOR. Rapamycin is a bacteria-derived antifungal drug that turned out to have anticancer properties. Scientists discovered the mTOR target, and now Merck & Co. and others are testing anticancer drugs believed to hit mTOR better than rapamycin does.

Charles Sawyers, a cancer researcher at Memorial Sloan-Kettering Cancer Center in New York, who was involved in the Gleevec research, says, "Natural products remain quite interesting and, often, represent the most exquisite examples of targeted therapies—selected for their activities through evolution."

2011年
01月30日
10:03
Studentさん

◯Rosieさん:

Student-tさん、参考文献のコピーありがとうございます。

Rosieさん、提案など色々ありがとうございます。

1)語順を変えて前におくとより明瞭ですね。
訳抜け補充ありがとうございます。致命傷です。
upper levelか higher levelでしょうか。

2) According to Eisai Co. in the clinical testsのところはdemonstratedも使えそうです。「治療法treatment」はmedicationも代用できると思います。
demonstrateいいですね。原文の「~によると」は抜きで対応しますか。
medication は薬物投与の治療法であれば使えると思います。ここでは明確でないので無難なところtreatmentかなと思いますが。

3) precursorの方がプロ的ですね。この単語あまり使いこなせてないです。

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