�Agile Therapeutics, Inc., proclaimed that it successfully completed two key clinical trials in the development of the company's new, innovative low-dose, once-weekly, contraceptive patch, which the company refers to by its internal product code AG-200-15. The Phase 2b safety and efficacy report successfully met its primary endpoint of ovulation suppression, cycle control and safety. The pharmacokinetic (PK) study demonstrated estrogen levels like with the well-established, low-dose oral preventative, LEVLEN�. There were no serious contrary events in either study. With the successful pharmacokinetic and Phase 2b safety and efficaciousness study results, the Company will discuss its Phase 3 plans for AG-200-15 with the Food and Drug Administration (FDA).
Daniel R. Mishell, M.D., Professor in the Department of Obstetrics and Gynecology at the University of Southern California, and a member of Agile's Scientific Advisory Board, commented, "Successful mop up of the Phase 2b safety and efficacy sketch is an important pace forward in proving the safety and efficacy of Agile's important, new low-dose contraceptive patch. For eld, OB/GYN's have been recommending low-dose oral contraceptives to their patients considering hormone-based contraceptives. If shown to be safe and effective, a low-dose, once-weekly birth control device patch would be a natural and needed addition to the hormonal-based contraceptives and an alternative to once-daily oral contraceptives."
Thomas Rossi, Ph.D., Agile's President and Chief Executive Officer, commented on the top-line data, "The purpose of conducting these studies was to present that our product delivers an allow, low dose of estrogen, and an effective dosage of the progestin, levonorgestrel. We ar very proud of with the clinical outcomes, which, in addition to helping us select the optimal dose for our Phase 3 program, too demonstrate that our patch gives reliable adhesion and is well tolerated when worn for 7 days. Based upon these results, we have been able to blue-ribbon AG-200-15 as our campaigner for Phase 3 development. We are looking fore to discussing our results with the FDA and solidifying our Phase 3 plan."
Pharmacokinetic Study
The pharmacokinetic study was an open-label, randomized, relative, single-center, two-period cross-over study with 39 patients that evaluated deuce contraceptive patches to date if the systemic photo of ethinyl estradiol (EE) and levonorgestrel (LNG) were comparable to the low-dose oral preventative, LEVLEN�. As intended, both the EE and LNG exposure over time of both patches were less than LEVLEN� and ordered with the levels targeted by the company.
Phase 2b Study
In this multi-centered, multi-cycle Phase 2b condom and efficacy study of 123 women, the Company studied patches with different estrogen and progestin doses for trey cycles to identify the regimen providing the best efficacy (as demonstrated by ovulation inhibition), cycle control and tolerability at the lowest hormonal dose. Top-line results from the trial showed there was a clear dose-response to ovulation suppression and cycle control. AG-200-15 provided the superlative ovulation suppression with the best cycle per second control of the troika regimens studied.
About Agile's Product
Agile's low-dose contraceptive patch offers women a convenient, once-weekly form of birth control. Many women prefer a weekly patch over having to remember to take the pill day-by-day. The Company's low-dose, patented, round, soft, and flexible patch delivers 60 percentage less oestrogen than the only marketed patch available today, Ortho EVRA�. New market research conducted by Agile in 2008 with approximately 1,000 women of procreative age high spot that more than 30 percent of women are not slaked with their current preventive methods. In addition, the vast legal age of these women establish Agile's low-dose contraceptive temporary hookup appealing and over 50 percent would talk with their doctors about exploitation it. Agile's low-dose preventive patch is expected to fill a sizeable demand in the $6 trillion global ($2.5 1000000000 U.S.) hormonal contraceptive market.
About Estrogen
Estrogen is associated with certain common side effects, such as breast tenderness, bloating/weight advance and nausea. These side effects are believed to be related to the level of hormones delivered into the blood current, particularly with higher levels of estrogen. In some rare cases, high estrogen levels are thought to be linked with good, cardiovascular side effects in some women. Therefore, low doses of estrogen in hormonal contraception are coveted.
According to FDA labeling, women victimisation Ortho EVRA� are exposed to about 60 percent more estrogen than if they were using distinctive birth control pills. Increased levels of estrogen english hawthorn increase the risk of blood clots, which lead the FDA to add together precautions to Ortho EVRA's label.
About Agile Therapeutics, Inc.
Agile Therapeutics is a in private held, specialty pharmaceutical fellowship focused on the development of innovative women's health care products. Historically, the women's healthcare market place offers unique opportunities to a company with proven expertise in clinical maturation, regulatory personal matters, transdermal do drugs delivery and commercialization see.
Agile's electric current venture investors include TL Ventures, Novitas Capital (erstwhile PA Early Stage Partners), ProQuest Investments, and The Hillman Company. The Company has brocaded a total of $35 million in venture backing to date.
Agile Therapeutics, Inc.
View dose information on Estradiol.
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Sunday, 7 September 2008
Monday, 18 August 2008
Mp3 music: Strung Out
 Artist: Strung Out: mp3 download Genre(s): Rock: Punk-Rock Strung Out's discography:  Live In A Dive Year: 2003 Tracks: 21  Twisted By Design Year: 1998 Tracks: 14  The Element Of Sonic Defiance Year: Tracks: 11  An American Paradox Year: Tracks: 13 Southern California punkers Strung Out were formed in 1992, with a batten order featuring vocalist Jason Cruz, guitarists Jake Kiley and Rob Ramos, bassist Jim Cherry, and drummer Jordan Burns (erstwhile of Ten Foot Pole, domain Health Organization joined up later the band's humble gear 7"). The five-spot signed with NOFX bassist Fat Mike's Fat Wreck Chords ticket in 1993 and issued a debut record album, Another Day in Paradise, the following year. The band took an esthetic leap frontwards with the 1996 follow-up, Suburban Teenage Wasteland Blues, an album whose rapid-fire playing began to build their following among fans of new-school punk-pop. In 1998 Strung Out issued the Juncture & Illusions EP and the full-length Distorted by Design, the latter a more progressive work that establish the group first to ruffle elements of technique-oriented heavy metal into its instrumental attack; in add-on, Fat Wreck Chords issued a fix of early Strung Out corporal coroneted The Skinny Years: Before We Got Fat. Cherry left the isthmus in 1999, departure on to play with Zero Down and Pulley, and was replaced by Chris Aiken on bass. The band returned in 2000 with the EP The Element of Sonic Defiance and followed two geezerhood later with An American Paradox, the band's first-class honours degree album to chart on Billboard (shoot number 11 on the Independent Albums chart). Their summer 2003 live record album featured 21 tracks and comic book graphics done by Cruz himself. Strung Out's one-fifth full-length, Deportee in Oblivion, was produced by Matt Hyde (Killer) and issued in November 2004; it contained the song "Wander Dive," which was a tribute to previous bassist Jim Cherry, wHO had woefully passed forth in July 2002 from a lifelong center term. In June of 2007 the band's next crusade, Blackhawks Over Los Angeles, came extinct. |
Missy Elliott
Friday, 8 August 2008
Jay-Z Brands Producer Timbaland 'premature'
Rapper JAY-Z is dandy to fossa music heavyweights TIMBALAND and KANYE WEST against each other - by claiming he will only opt the topper of their offered tracks.
Reports suggested hitmaker Timbaland was set to bring on every track for the 99 Problems star's forthcoming album.
But Jay-Z has distanced himself from the superproducer's claims, insisting Timbaland's producing plans were "previous".
And if that wasn't enough of a suck to the Elevator hotshot, Jay-Z has namechecked Kanye West as a possible producer for the LP - depending on whether the singer/rapper can come up with the goods.
Jay-Z tells Rolling Stone magazine, "I'm a someone that whole kit and caboodle off music.
"If Timbaland makes 10 great tracks then he produces the album, if Kanye West makes 10 great tracks then he produces the album; if he makes three, I'll take trey. I get the euphony dictate the direction."
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Tuesday, 1 July 2008
Tomaz Pengov
Artist: Tomaz Pengov
Genre(s):
Dance
Discography:
Rimska cesta
Year: 1999
Tracks: 13
Odpotovanja
Year: 1973
Tracks: 13
Madonna tickets selling fast: Live Nation
Thursday, 19 June 2008
‘Miracle at St. Anna’ Trailer: Spike Lee Goes to War
Tagline: "In World War II, there were heroes and miracles."
Translation: You know, all the stuff happening in the background in Clint Eastwood's WWII movies.
The Verdict: Given recent events, it's hard not to see the new trailer for Spike Lee's Miracle at St. Anna as a rebuttal to Eastwood's perceived whitewashing of WWII in Flags of Our Fathers. It's also hard not to see it as a surefire, all-bases-covered Oscar contender (after we figured Lee had given up on that sort of thing): There's war! Nazis! Prison drama! Forbidden romance! Civil rights! Religious unrest! Dying children! Joseph Gordon-Levitt playing a tough-talking grown-up! Additionally, it looks really, really great, and we kind of can't wait to see it.
Translation: You know, all the stuff happening in the background in Clint Eastwood's WWII movies.
The Verdict: Given recent events, it's hard not to see the new trailer for Spike Lee's Miracle at St. Anna as a rebuttal to Eastwood's perceived whitewashing of WWII in Flags of Our Fathers. It's also hard not to see it as a surefire, all-bases-covered Oscar contender (after we figured Lee had given up on that sort of thing): There's war! Nazis! Prison drama! Forbidden romance! Civil rights! Religious unrest! Dying children! Joseph Gordon-Levitt playing a tough-talking grown-up! Additionally, it looks really, really great, and we kind of can't wait to see it.
Wednesday, 11 June 2008
Yoko Ono scores in feud over rare Lennon footage
BOSTON (Reuters) - John Lennon's widow, Yoko Ono, made big strides on Wednesday in a legal feud over footage of the former Beatle smoking pot, writing songs and discussing putting the hallucinogenic drug LSD in President Richard Nixon's tea.
Ono is in a legal dispute to stop World Wide Video, a New England consortium of Beatles collectors, from releasing the black-and-white footage as a two-hour film titled "3 days in the life" about Lennon during a pivotal and turbulent time for the most celebrated band of the 1960s.
U.S. District Court Judge Rya Zobel in Boston ruled in favor of Ono in two counts in a case involving videotapes that Rolling Stone magazine has described as "awesome John Lennon footage you might never see."
The case is centered around who owns the nine hours of raw footage filmed weeks before the "Fab Four" broke up in 1970.
World Wide Video claims ownership of the videos and says it paid more than $1 million for them after legal costs and other expenses. Ono's lawyers say she purchased the tapes from World Wide through a Florida man.
After that, the case gets murky. World Wide asserts that the tapes were stolen and were sold to Ono illegally, and sued Ono for copyright infringement in a bid to publicly show them.
Zobel told the court that Ono did not do anything constituting infringement -- from performing copyrighted work publicly, or distributing or publicly displaying the videos.
"What the plaintiff suggests just doesn't fit," Zobel said. "It seems to me the defendant's motion is well taken because there was no infringement."
Ono is in a legal dispute to stop World Wide Video, a New England consortium of Beatles collectors, from releasing the black-and-white footage as a two-hour film titled "3 days in the life" about Lennon during a pivotal and turbulent time for the most celebrated band of the 1960s.
U.S. District Court Judge Rya Zobel in Boston ruled in favor of Ono in two counts in a case involving videotapes that Rolling Stone magazine has described as "awesome John Lennon footage you might never see."
The case is centered around who owns the nine hours of raw footage filmed weeks before the "Fab Four" broke up in 1970.
World Wide Video claims ownership of the videos and says it paid more than $1 million for them after legal costs and other expenses. Ono's lawyers say she purchased the tapes from World Wide through a Florida man.
After that, the case gets murky. World Wide asserts that the tapes were stolen and were sold to Ono illegally, and sued Ono for copyright infringement in a bid to publicly show them.
Zobel told the court that Ono did not do anything constituting infringement -- from performing copyrighted work publicly, or distributing or publicly displaying the videos.
"What the plaintiff suggests just doesn't fit," Zobel said. "It seems to me the defendant's motion is well taken because there was no infringement."
Thursday, 5 June 2008
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