�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 maculation, which the company refers to by its interior product code AG-200-15. The Phase 2b safety and efficacy study successfully met its primary endpoint of ovulation inhibition, cycle control and safety. The pharmacokinetic (PK) study demonstrated oestrogen levels comparable with the well-established, low-dose oral preventive, LEVLEN�. There were no serious inauspicious events in either sketch. With the successful pharmacokinetic and Phase 2b condom and efficacy study results, the Company will hash out 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 windup of the Phase 2b safety and efficacy study is an important step forward in proving the safety and efficacy of Agile's important, new low-dose contraceptive patch. For long time, OB/GYN's take in been recommending low-dose oral contraceptives to their patients considering hormone-based contraceptives. If shown to be safe and efficacious, a low-dose, once-weekly preventive patch would be a natural and needed gain 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 certify that our product delivers an capture, low acid of oestrogen, and an effective dose 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 dependable adhesion and is well tolerated when worn for 7 days. Based upon these results, we sustain been able to prime AG-200-15 as our campaigner for Phase 3 developing. We are looking ahead to discussing our results with the FDA and solidifying our Phase 3 plan."
Pharmacokinetic Study
The pharmacokinetic study was an open-label, randomized, comparative, single-center, two-period cross-over report with 39 patients that evaluated iI contraceptive patches to see if the systemic exposure of ethinyl estradiol (EE) and levonorgestrel (LNG) were comparable to the low-dose oral preventive, LEVLEN�. As intended, both the EE and LNG exposure over time of both patches were less than LEVLEN� and uniform with the levels targeted by the company.
Phase 2b Study
In this multi-centered, multi-cycle Phase 2b safety and efficaciousness study of 123 women, the Company studied patches with different estrogen and progestin doses for tercet cycles to identify the regimen providing the best efficacy (as demonstrated by ovulation suppression), 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 greatest ovulation inhibition with the best cycle control of the deuce-ace regimens studied.
About Agile's Product
Agile's low-dose contraceptive mend offers women a commodious, once-weekly manikin of birth control. Many women favor a weekly patch over having to remember to take the pill daily. The Company's low-dose, patented, round, cushy, and flexible patch delivers 60 pct less estrogen than the only marketed patch available today, Ortho EVRA�. New market inquiry conducted by Agile in 2008 with approximately 1,000 women of procreative age highlighting that more than 30 percent of women ar not satisfied with their current contraceptive methods. In addition, the vast majority of these women establish Agile's low-dose contraceptive bandage appealing and over 50 percent would talk with their doctors about victimisation it. Agile's low-dose contraceptive patch is expected to fill a sizeable want in the $6 billion global ($2.5 zillion U.S.) hormonal contraceptive market.
About Estrogen
Estrogen is associated with certain usual side effects, such as breast tenderness, bloating/weight put on and nausea. These incline effects are believed to be related to to the level of hormones delivered into the blood flow, particularly with higher levels of oestrogen. In some rare cases, high oestrogen levels are thought to be linked with grave, cardiovascular side effects in some women. Therefore, low-pitched doses of estrogen in hormonal contraception are sought after.
According to FDA labeling, women using Ortho EVRA� are uncovered to around 60 percent more estrogen than if they were using typical birth controller pills. Increased levels of estrogen crataegus oxycantha increase the risk of blood clots, which lead the FDA to add precautions to Ortho EVRA's label.
About Agile Therapeutics, Inc.
Agile Therapeutics is a privately held, distinctiveness pharmaceutical company focused on the development of forward-looking women's health care products. Historically, the women's healthcare grocery offers unique opportunities to a company with proven expertise in clinical development, regulatory affairs, transdermal drug delivery and commercialization see.
Agile's flow venture investors include TL Ventures, Novitas Capital (once PA Early Stage Partners), ProQuest Investments, and The Hillman Company. The Company has elevated a total of $35 million in venture financing to date.
Agile Therapeutics, Inc.
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Friday, 5 September 2008
Tuesday, 26 August 2008
Mp3 music: Hammerfall
 Artist: Hammerfall: mp3 download Genre(s): Metal Rock Metal: Heavy-Metal Metal: Heavy Metal: Power Hammerfall's discography:  Steel Meets Steel - Ten Years of Glory (cd1) Year: 2007 Tracks: 15  Stee Meets Steel-Ten Years of Glory (cd2) Year: 2007 Tracks: 14  Threshold Year: 2006 Tracks: 13  Blood Bound Year: 2005 Tracks: 3  One Crimson Night (CD 2) Year: 2003 Tracks: 9  One Crimson Night (CD 1) Year: 2003 Tracks: 13  Crimson Thunder Year: 2002 Tracks: 12  Always Will Be Year: 2001 Tracks: 4  Renegade Year: 2000 Tracks: 10  Renegade Year: 2000 Tracks: 3  Live In Sweden (bootleg) Year: 1999 Tracks: 10  I Want Out (ep) Year: 1999 Tracks: 3  Legacy Of Kings Year: 1998 Tracks: 10  Heeding The Call (ep) Year: 1998 Tracks: 5  Glory To The Brave(Singles) Year: 1997 Tracks: 4  Glory To The Brave Year: 1997 Tracks: 9 Following their formation in 1993, Hammerfall underwent legion personnel department changes earlier subsiding on their current batting ordering, which includes principal songwriters Joachim Cans (vocals) and Oscar Dronjak (guitars). In Flames skinbeater Jesper Stromblad contributed to their debut, although Patrick Rafling replaced him shortly afterwards. Since the sack of their debut Aura to the Brave in 1997, Hammerfall have got become peerless of the toasts of the Eurometal tantrum, residing in Germany's Top century for over two months, with Glory dubbed Album of the Year by Rock Hard magazine publisher. The Swedish bikers bear too played numerous metallic element fests, including the Wacken Open Air Festival; they returned in 1999 with the EP I Want Out. Renegade was issued a year later. |
Groucho Marx | Download mp3
Thursday, 7 August 2008
Bonerama
Artist: Bonerama
Genre(s):
Jazz
Discography:
Live From New York
Year:
Tracks: 13
Live at the Old Point
Year:
Tracks: 10
Rock-oriented New Orleans brass band Bonerama were formed by trombonists Mark Mullins and Craig Klein, both of whom had been members of Harry Connick's band since 1990. Mullins obtained a weekly residency at the New Orleans night club Tipitina's in the summer of 1998 and turned it into a trombone summit. In addition to Klein, he enlisted trombonists Rick Trolsen, Steve Suter, and Brian O'Neill (world Health Organization died of a heart tone-beginning in December 2005), as comfortably as bass horn musician Matt Perrine and guitarist Bert Cotton. The brake drum chair has been held at versatile times by Eric Bolivar, Terence Higgins, Russell Batiste, and Stanton Moore. Despite its horn-heavy instrumentality, Bonerama were a rock band, known for playing such covers as "Frankenstein" by the Edgar Winter Group along with songs by Jimi Hendrix, Led Zeppelin, Black Sabbath, and the Allman Brothers Band. The group's number one album, Live at the Old Point, was released on October 9, 2001. Live from New York followed on August 26, 2005. Bonerama's third cogwheel back-to-back live record record album, Delivery It Home, which had been recorded at Tipitina's, was released on July 24, 2007.
Friday, 27 June 2008
Elsa & Fred
Elsa & Fred is a romantic comedy about the irresistible power and total madness of love when two people who, at the end of the road, discover that it?s never too late to love? or to dream.
Tuesday, 24 June 2008
Dave Grusin and GRP All-Star Big Band
Artist: Dave Grusin and GRP All-Star Big Band
Genre(s):
Jazz
Discography:
Dave Grusin Presents GRP All-Star Big Band: Live!
Year: 1993
Tracks: 10
Broadway Stars to Katie: Sleep!
Wednesday, 18 June 2008
December Wolves
Artist: December Wolves
Genre(s):
Metal: Death,Black
Metal
Discography:
Completely Dehumanized
Year: 1998
Tracks: 9
Completeley Dehumanized
Year:
Tracks: 9
Blasterpiece Theatre
Year:
Tracks: 11
Appropriately hailing from Salem, Massachusetts, the black alloy dance orchestra December Wolves formed in 1993, recording their first demo a yr by and by. The band gestural to Hammerheart Records and issued their debut album in 1996; a switch to the Wicked World pronounce produced 1999's Completely Dehumanized. Three eld after December Wolves returned with Blasterpiece Theatre, their first album for Earache.
Apples in Stereo
Artist: Apples in Stereo
Genre(s):
Indie
Other
Discography:
New Magnetic Wonder
Year: 2007
Tracks: 24
Fun Trick Noisemaker
Year: 1995
Tracks: 13
Sunny pop stria the Apples in Stereo were one of the leading lights of the Elephant 6 Recording Company collective, a clique of like-minded, lo-fi indie groups -- including the Olivia Tremor Control, Neutral Milk Hotel, and Secret Square -- world Health Organization shared musicians, ideas, and sensibilities. They were light-emitting diode by singer/songwriter Robert Schneider, a native of the diminutive townsfolk of Ruston, LA, also home to Jeff Mangum (by and by of Neutral Milk Hotel) as well as William Cullen Hart and Bill Doss (world Health Organization formed the Olivia Tremor Control). Throughout high school, the wishful musicians -- all influenced by the likes of the Beatles, the Zombies, Pink Floyd, and Sonic Youth -- exchanged home recordings and played in each other's bands.
After college, Schneider and Mangum relocated to Denver, CO, where Schneider stricken up a friendship with fellow Beach Boys fan and bass player Jim McIntyre; after recruitment drummer Hilarie Sidney and guitarist Robert Parfitt, they formed the Apples and issued their self-titled debut EP on the Elephant 6 label. To keep off confusion with other similarly named bands, they officially became the Apples in Stereo for 1995's full-length debut, Sport Trick Noisemaker. In 1996, Schneider produced the Olivia Tremor Control's Music from the Unrealized Film Script, Dusk at Cubist Castle and later in the year the Apples issued Science Faire, a compendium of singles and rare corporeal.
The Apples in Stereo returned in the fall of 1997 with Tone Soul Evolution; shortly after its button, the band sign a distribution apportion with Sire and the album was re-released in January of the next year. The splendid Her Wallpaper Reverie followed in the bounce of 1999, and a year later the band returned with the equally rattling The Discovery of a World Inside the Moone. The mathematical group likewise contributed a song to 2000's Heroes & Villains: Music Inspired by the Powerpuff Girls, and in 2001 they released the Let's Go! EP, which featured the track from Heroes & Villains on with a cover of the Beach Boys classic of the same name. In fall 2002, Schneider and the Apples in Stereo issued their well-nigh challenging cause to date, Velocity of Sound. Soon later on the band went on hiatus with members focussing on other projects (Schneider with Marbles and Ulysses, Sidney with the High Water Marks).
In 2006 they reconvened to record New Magnetic Wonder for worker Elijah Wood's new label, Simian (in conjunction with Yep Roc). Before the record strike the shelves, the band's lineup suffered a blow with the going of Sidney in late 2006. Her replacement, the Deathray Davies frontman John Dufilho, was added to a band that apart from Schneider too included ex-Olivia Tremor Control fellow member Bill Doss on keyboards, guitar player John Hill, and bassist Eric Allen. The band was minded a boost by the appearance of Schneider, telling "Sir Leslie Stephen, Stephen" -- his ode to the good looks of Stephen Colbert-- on the notorious "Jet Screen Challenge" episode of The Colbert Report.
Can Robot Bands Save the Music Business?
Yes, we all agree that machines will someday become self-aware, then rise up and enslave whichever parts of humanity aren't brutally dismembered during the ensuing robo-mêleé — but what of their short-term benefits? Gizmodo today directs us to the MySpace page of the Trons, a Velvet Underground–y garage-rock combo of four robots from New Zealand. And, as much as it terrifies us to admit this, they're actually pretty good. Sure, their lyrics may be in a made-up robot language, but so are most of Lou Reed's. Also, they're polite, not prone to drug addiction or annoying in-studio experimentation, and if they ever try to record a concept album, they can simply be unplugged. Can robots save recorded music? (Before they kill everyone, that is.)
Robot Band is at Least as Good as Coldplay [Gizmodo]
The Trons [MySpace]
Earlier: Vulture's previous coverage of the impending robot apocalypse
Robot Band is at Least as Good as Coldplay [Gizmodo]
The Trons [MySpace]
Earlier: Vulture's previous coverage of the impending robot apocalypse
Kevin Russell
Artist: Kevin Russell
Genre(s):
Blues
Discography:
S.F. Blues Guitar Summit, Vol. 3
Year: 1993
Tracks: 8
Steven Spielberg has $1 billion dream
Sugar denies using booster seat
'The Apprentice' boss Alan Sugar has dismissed suggestions that he uses a booster seat to appear taller in the hit show's boardroom scenes.
A makeshift wooden platform has allegedly been seen under the 5'6" businessman's boardroom chair but he told the Press Association: "That's a load of rubbish.
"The chair is fixed to stop it moving backwards and forwards while allowing me to swing to the left and the right.
"Anyone who watches the programme will know that I stand next to Nick [Hewer] and Margaret [Mountford] and the candidates, and I'm seen getting out of the car thousands of times.
"It's a total joke. It's there to secure the four wheels to stop it moving backwards and forwards. It's a total joke."
Sugar made the comments ahead of tonight's 'The Apprentice' finale (BBC 1, 9pm) in which Alex Wotherspoon, 25, Helene Speight, 32, Claire Young, 29, and Lee McQueen, 30 are the four contenders.
Speaking about the last episode, Sugar said: "It's obviously difficult when you're down to the last four people that have gone through the whole process of 11 weeks. The decision gets a bit difficult."
He said of the finalists: "Claire is a fantastic sales person. She's a very, very good presenter and also has a very good business brain.
"Lee is a great sales person. He has a fighting spirit and is determined to succeed, to get on with it. He is very focused."
On Alex, he said: "He's young and has been a very good sales person. He's very intelligent and you shouldn't underestimate his intelligence."
Speaking about Helene he added: "Helene has been brought up in a corporate environment and is a 'steady Eddie'. She's very strategic."
Sugar also said of the candidates: "They've all got weaknesses too. Claire jabbers too much sometimes, she can be a bit overpowering.
"Lee could get too excited from time-to-time, Alex gets a little bit sensitive, and Helene can also be a bit defensive, that's the blame culture of a corporate environment."
Sugar would not reveal the job that awaits the winner, saying: "That will boil down to the candidate choice at the end."
He said he had no regrets about his firings.
Sugar also revealed that he had an affinity for some of the fired contestants.
He said: "Certain candidates still keep in contact with me and I'm more than happy to continue a rapport with Simon (Smith), Raef (Bjayou) or Sara (Dhada)."
Click here to read 'The Apprentice' TV Blog.
A makeshift wooden platform has allegedly been seen under the 5'6" businessman's boardroom chair but he told the Press Association: "That's a load of rubbish.
"The chair is fixed to stop it moving backwards and forwards while allowing me to swing to the left and the right.
"Anyone who watches the programme will know that I stand next to Nick [Hewer] and Margaret [Mountford] and the candidates, and I'm seen getting out of the car thousands of times.
"It's a total joke. It's there to secure the four wheels to stop it moving backwards and forwards. It's a total joke."
Sugar made the comments ahead of tonight's 'The Apprentice' finale (BBC 1, 9pm) in which Alex Wotherspoon, 25, Helene Speight, 32, Claire Young, 29, and Lee McQueen, 30 are the four contenders.
Speaking about the last episode, Sugar said: "It's obviously difficult when you're down to the last four people that have gone through the whole process of 11 weeks. The decision gets a bit difficult."
He said of the finalists: "Claire is a fantastic sales person. She's a very, very good presenter and also has a very good business brain.
"Lee is a great sales person. He has a fighting spirit and is determined to succeed, to get on with it. He is very focused."
On Alex, he said: "He's young and has been a very good sales person. He's very intelligent and you shouldn't underestimate his intelligence."
Speaking about Helene he added: "Helene has been brought up in a corporate environment and is a 'steady Eddie'. She's very strategic."
Sugar also said of the candidates: "They've all got weaknesses too. Claire jabbers too much sometimes, she can be a bit overpowering.
"Lee could get too excited from time-to-time, Alex gets a little bit sensitive, and Helene can also be a bit defensive, that's the blame culture of a corporate environment."
Sugar would not reveal the job that awaits the winner, saying: "That will boil down to the candidate choice at the end."
He said he had no regrets about his firings.
Sugar also revealed that he had an affinity for some of the fired contestants.
He said: "Certain candidates still keep in contact with me and I'm more than happy to continue a rapport with Simon (Smith), Raef (Bjayou) or Sara (Dhada)."
Click here to read 'The Apprentice' TV Blog.
Minnie Driver - Driver Goes Green For Baby Girl
Pregnant actress MINNIE DRIVER is craving green apples and cucumbers after dreaming her unborn baby loves all things veggie.
The Good Will Hunting star felt sure she would want to gobble sweet treats throughout her pregnancy but she's delighted her cravings have all been good and green.
She says, "Green apples are my obsession and cucumber and snap peas, all green foods. It's weird. I really haven't had this huge appetite.
"There's no room to eat tons of stuff. I was ready for having this massive appetite that I heard about but it just never kicked in. I'm really quite lucky.
"I had a dream and they told me in the dream that her (baby) favourite colour is green. Maybe that's why I like green food so much."
Driver, who has three months to go before giving birth to her first child, admits she's having an "easy pregnancy" now the morning sickness has abated.
She adds, "I have a bionic sense of smell that's hardcore. Everything becomes overpowering like aftershave, perfume, and scented candles.
"I'm happy the nausea finally went away; that was the worst part, the sickness and the throwing up to begin with was wretched. Otherwise it's been very peaceful."
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