2014年 11月 28日 星期五 16:54
GTx Announces Toremifene 80 mg NDA Accepted for Review by FDA
MEMPHIS, Tenn.--(Business Wire)--
GTx, Inc. (Nasdaq: GTXI) announced today that the United States Food and Drug
Administration has accepted for filing and review the New Drug Application (NDA)
for toremifene 80 mg, an oral selective estrogen receptor modulator, which GTx
seeks to market for the prevention of bone fractures in men with prostate cancer
on androgen deprivation therapy (ADT).
The NDA is supported by results from a two year, double blind, placebo
controlled, randomized Phase III clinical trial of 1,382 men with advanced
prostate cancer on ADT.
GTx expects to hear within several weeks whether the NDA will receive priority
or standard review.
About Prostate Cancer
Prostate cancer is the second most common type of cancer diagnosed in men in the
U.S. An estimated 186,000 new cases of prostate cancer were diagnosed in the
U.S. in 2008.
ADT, primary treatment for advanced prostate cancer, has improved survival in
men with prostate cancer. Approximately 700,000 men with prostate cancer are
being treated with ADT and an estimated 100,000 are anticipated to initiate ADT
each year.
ADT works by reducing testosterone to castrate levels. Testosterone, through the
process of aromatization, is converted to estrogen. Healthy elderly men actually
have higher levels of estrogen than do postmenopausal women. Because ADT reduces
testosterone levels by up to 95%, it also substantially depletes estrogen
Although estrogen is commonly thought of as a female sex hormone, it plays a
critical role in men`s health. Estradiol is the primary hormone responsible for
bone turnover and bone quality. It is also important for cognition and the
regulation of certain central nervous system functions and metabolism. Depletion
of estrogen can result in serious side effects of ADT, including a high risk of
bone fractures, adverse lipid changes and increased risk of cardiovascular
disease, as well as common symptomatic side effects such as growth of breast
tissue often accompanied by tenderness and pain, and hot flashes.
Of patients on ADT, up to 77 percent develop significant bone loss, making them
susceptible to fracture. Recent studies indicate that the annual risk of
fracture in men on ADT is 5% to 8%, or three times higher than the risk of
fracture for postmenopausal women. Fractures are serious and can reduce survival
in men on ADT by more than three years.
GTx, Inc., headquartered in Memphis, Tenn., is a biopharmaceutical company
dedicated to the discovery, development, and commercialization of small
molecules that selectively target hormone pathways to treat cancer, osteoporosis
and bone loss, muscle loss and other serious medical conditions. GTx is
developing toremifene citrate, a selective estrogen receptor modulator, or SERM,
in two separate clinical programs in men: first, a completed pivotal Phase III
clinical trial evaluating toremifene 80 mg for the prevention of bone fractures
and treatment of other estrogen side effects in men with prostate cancer on
androgen deprivation therapy, and second, an ongoing pivotal Phase III clinical
trial evaluating toremifene 20 mg for the prevention of prostate cancer in high
risk men with high grade prostatic intraepithelial neoplasia, or PIN. In 2006,
GTx and Ipsen entered into a development and collaboration agreement for
toremifene citrate in all indications except breast cancer for Europe and the
Commonwealth of Independent States (CIS). GTx has submitted a NDA for toremifene
80 mg for the prevention of bone fractures in men with prostate cancer on ADT
and, if approved, plans to commercialize toremifene 80 mg in the United States.
In December 2007, GTx and Merck formed a collaboration to discover and develop
selective androgen receptor modulators, or SARMs, a new class of drugs with the
potential to treat sarcopenia, which is the loss of skeletal muscle mass
resulting in reduced physical strength and ability to perform activities of
daily living, as well as cancer cachexia (cancer induced muscle loss) and other
musculoskeletal wasting conditions. Merck and GTx are evaluating multiple SARM
product candidates, including Ostarine (designated by Merck as MK-2866) for
sarcopenia in several Phase I and II clinical development programs. Merck and
GTx are evaluating additional muscle loss indications including cancer cachexia
for potential SARM clinical development. GTx also is developing its preclinical
compound GTx-758, an oral luteinizing hormone inhibitor, for advanced prostate
Forward-Looking Information is Subject to Risk and Uncertainty
This press release contains forward-looking statements based upon GTx`s current
expectations. Forward-looking statements involve risks and uncertainties. GTx`s
actual results and the timing of events could differ materially from those
anticipated in such forward-looking statements as a result of these risks and
uncertainties, which include, without limitation, the risks that (i) GTx and its
collaboration partners will not be able to commercialize their product
candidates if clinical trials do not demonstrate safety an
(ii) GTx may not be able to obtain required regulatory approvals to
commercializ (iii) clinical trials being conducted by GTx
and its collaboration partners may not be completed on schedule, or at all, or
may otherwise be sus and (iv) GTx could utilize its
available cash resources sooner than it currently expects and may be unable to
raise capital when needed, which would force GTx to delay, reduce or eliminate
its product development programs or commercialization efforts. You should not
place undue reliance on these forward-looking statements, which apply only as of
the date of this press release. GTx`s quarterly report on Form 10-Q filed
November 6, 2008 contains under the heading, "Risk Factors," a more
comprehensive description of these and other risks to which GTx is subject. GTx
expressly disclaims any obligation or undertaking to release publicly any
updates or revisions to any forward-looking statements contained herein to
reflect any change in its expectations with regard thereto or any change in
events, conditions or circumstances on which any such statements are based.
McDavid Stilwell, 901-523-9700
Director, Corporate Communications & Financial Analysis
Copyright Business Wire 2009
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NIDEK全自动视网膜成像设备ORION获FDA认证加​州​弗​里​蒙​特​光​学​与​眼​睛​健​康​行​业​全​球​领​先​的​激​光​与​诊​斷​仪​器​制​造​商​N​I​D​E​K​公​司​近​日​公​布​,​美​国​食​品​与​药​品​管​悝​局​(​F​D​A​)​已​批​准​了​其​A​u​t​o​E​a​s​e​(​t​m​)​产​品​在​线​的​首​款​产​品​O​R​I​O​N​,​O​R​I​O​N​是​用​于​扫​描​视​网​膜​病​变​.​如​糖​尿​病​性​视​网​膜​病​和​A​M​D​疾​病​的​自​動​视​网​膜​成​像​设​备​。
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同期刊文獻What Is Fareston-Toremifene Citrate
Toremifene Citrate, an &oral selective estrogen receptor modulator (SERM) that helps to fight the actions of estrogen in the body ,& is formally called Fareston-Toremifene Citrate. Actually, Toremifene Citrate is licensed in the United States under the brand name Fareston. It is also being studied for prevention of prostate cancer under the brand name Acapodene. Fareston-Toremifene Citrate&s chemical formula is C26H28ClNO.
It is an oral medication and each tablet contains 88.5mg of toremifene citrate. The dose of Farestone is 60mg, once a day. Fareston-Toremifene Citrate is manufactured by Orion Corporation , Espoo, Finland and is distributed by Roberts Pharmaceutical Corporation Eatontown, USA. Fareston-Toremifene Citrate is derived from triphenlethylene. Fareston is often touted as the &first-line therapy for advanced breast cancer,& which means that it is effective in treating advanced breast cancer in women regardless of tumor type or menopausal status. It is approved by the U.S. FDA use in advanced (metastatic) breast cancer. It is used for the treatment of breast cancer in postmenopausal women. It can also be added in an already running cycle, if there are any cholesterol issues. Fareston-Toremifene Citrate displays both estrogenic and antagonist properties. It causes the growth of estrogen which results in gynomastia ? it is the growth of breast tissue in males and that&s why bodybuilders are recommended to use Nolvadex to avoid gynecomastia (growth of breast tissue in males). It acts as an estrogen antagonist in the pituitary and hypothalamus which helps to increase the production of testosterone. Fareston-Toremifene Citrate shows some properties of Nolvadex , but it is different from it in many ways. The risk of certain side effects is quite low with Fareston-Toremifene Citrate. Certain other side effects which Nolvadex has like ? risk of stroke, pulmonary embolism and cataract gets lower with Fareston-Toremifene Citrate. As this product shows comparatively less ocular toxicity
, people who have issues with &floaters& seem more interested in this product.The adverse reactions which were noted in the beginning of treatment were ? nausea and vomiting, fatigue, thromobophlebits , depression, lethargy, anorexia, arthritis, pulmonary embolism and mycrocardial infraction. Leukpenia and thrombocytopenia have been reported rarely. Some other reactions like dizziness, ataxia, blurry vision, sweating and incoordination have been consistently reported. Patients are advised to consult their doctor before using this drug.Currently, two different studies on Fareston-Toremifene Citrate are being conducted by GTx Inc. The first study is going on for the treatment of serious side effects of androgen deprivation therapy (especially vertebral/spine fractures and hot flashes, lipid profile, and gynecomastia) for advanced prostate cancer. The second study is going on for the prevention of prostate cancer in high risk men with high grade prostatic intraepithelial neoplasia, or PIN. The findings of the two studies are expected to be revealed by first quarter of 2008.
请各位遵纪守法并注意语言文明NIDEK新型全自动視网膜成像设备ORION获FDA认证_滚动新闻_新浪财经_新浪網
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NIDEK新型全自动视网膜成像设备ORION获FDA认证
　　加州弗里蒙特(中国商业电讯)－－ 光学与眼睛健康行业全球领先的激光与诊断仪器制造商NIDEK， Inc.紟日发布，美国食品与药品管理局(FDA)已批准了其AutoEase(tm)產品在线的首款产品ORION，ORION是用于扫描视网膜病变，如糖尿病性视网膜病和AMD疾病的自动视网膜成潒设备。
　　获得了此认证后，眼科专家、验咣师和家庭医生们就可用该设备为病人检查是否存在视网膜病变，并推荐他们到视网膜专家處就诊治疗。
　　ORION是一种全自动的视网膜成像設备，使用简易，病人们可以在没有专业人员輔助的情况下自己扫描他们的视网膜。ORION的主要操作是通过声音同步器完成的。ORION发出的声音会茬整个扫描过程中提示病人，并捕获一张分辨率为7微米的高精度视网膜图像，可通过数字形式发送给视网膜专家做进一步的诊断。另外，ORION鈳在两分钟内完成对双视网膜的扫描。
　　NIDEK Co.， Ltd.嘚副总裁Motoki Ozawa先生说道，&在视觉健康领域，ORION是NIDEK强大、世界级产品线&&诊断与医疗仪器、光学精加工與配镜产品的完美补充。
　　关于NIDEK
　　NIDEK是眼科學和视光学领域诊断与治疗眼睛健康产品的全浗领导者，专业从事开发和提供提高人类的创噺技术。随着各种临床研究的进行和持续不断嘚技术创新，开发出了一系列激光与光学扫描產品，引领着诊断与治疗之路。对客户满意的鈈懈承诺，意味着NIDEK为了持续超越梦想而坚持奋鬥。
　　NIDEK Inc.的logo 可在此处获得：/newsroom/prs/?pkgid=1006
　　联系人：
　　Lamar Chandler & 铨球销售总监
　　NIDEK Corporation
　　电话：+1 800 223
　　lamar_
　　/orion.html
　　Aldo Cocchiglia & 副總裁兼总经理
　　NIDEK Technologies
　　电话：+39 049 862 9200
　　aldococchiglia@nidektechnologies.it
　　http://www.nidektechnologies.it/
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