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QuatRx Announces Further Positive Phase 3 Results For Ophena(TM) (Ospemifene Tablets) In Postmenopausal Vaginal Atrophy
QuatRx Pharmaceuticals Company, a privately-held biopharmaceutical company, announced positive top-line efficacy results from the first of two patient cohorts in its second pivotal Phase 3 trial of the investigational compound, Ophena(TM) (ospemifene tablets), for the treatment of postmenopausal vulvovaginal atrophy (VVA). The Company has also successfully completed two long term safety extension studies from its first pivotal Phase 3 studies. QuatRx intends to use these results in support of a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) in early 2010 seeking approval for Ophena(TM), a new SERM (selective estrogen receptor modulator) for the treatment of the symptoms of vulvovaginal atrophy. Ophena(TM) is the only non-estrogen therapy currently in late-stage development for the treatment of vaginal symptoms associated with menopause.
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Senate Democrats Meet With White House Adviser To Craft Response To Republican Criticism On Health Reform
Senate Democrats on Wednesday worked with senior White House adviser David Axelrod to craft a health care message focused on affordability and choice, the AP/Contra Costa Times reports (Werner, AP/Contra Costa Times, 5/13). The meeting followed the release of a memo last week by Republican strategist Frank Luntz outlining how to criticize Democratic plans for health reform (Budoff Brown/McGrane, Politico, 5/13). Senate Majority Whip Richard Durbin (D-Ill.) said Luntz"s memo was "an interesting catalyst for us" (AP/Contra Costa Times, 5/13).Axelrod presented Democrats with polling data about what U.S. residents are seeking from a health care overhaul and discussed better word choices, such as "shared responsibility" rather than "mandates" for coverage requirements. According to CongressDaily, the meeting centered Democrats on a coordinated message that the U.S. health care system must be affordable and accessible and should be patient-focused (Edney/Condon, CongressDaily, 5/13). Sen. Evan Bayh (D-Ind.) said that many Democrats felt "unease that we did not have a strategy" to answer the attacks coming from Republicans (Pear, New York Times, 5/14). Senate Finance Committee Chair Max Baucus (D-Mont.) said, "Everybody in the room had been a little nervous that, "Gee, Democrats don"t have their act together"" (CongressDaily, 5/13). However, Bayh said that "Axelrod came to reassure us that they do have a strategy" (New York Times, 5/14). Durbin said, "This is an effort to coordinate our message so we present a health care reform effort the American people trust" (Armstrong, CQ Today, 5/13). According to Durbin, Axelrod emphasized that Democrats should continue with the campaign theme that the goal of an overhaul is to "fix what"s broken in the system and preserve what"s good" (Young, The Hill, 5/13).Sen. Charles Schumer (D-N.Y.) said, "We believe the public shares our views. But we don"t want to be overwhelmed by either res, messaging or boots on the ground." He added, "We won"t make the mistake of 1993-94." According to the New York Times, a plan developed by the administration of former President Clinton "collapsed" in the face of Republican criticism (New York Times, 5/14).
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Biomedical Imaging: Twinkling Nanostars Cast New Light

Purdue University researchers have created magnetically responsive gold nanostars that may offer a new approach to biomedical imaging. The nanostars gyrate when exposed to a rotating magnetic field and can scatter light to produce a pulsating or "twinkling" effect. This twinkling allows them to stand out more clearly from noisy backgrounds like those found in biological tissue. Alexander Wei, a professor of chemistry, and Kenneth Ritchie, an associate professor of physics, led the team that created the new gyromagnetic imaging method. "This is a very different approach to enhancing contrast in optical imaging," said Wei, who also is a member of the Purdue University Center for Cancer Research and the Oncological Sciences Center. "Brighter isn"t necessarily better for imaging; the real issue is background noise, and you can"t always overcome this simply by creating brighter particles. With gyromagnetic imaging we can zero in on the nanostars by increasing signal strength while cutting down on background noise." The gold nanostars are about 100 nanometers from tip to tip and contain an iron-oxide core that causes them to spin when exposed to a rotating magnet. The arms of the nanostar are designed to respond to a light and reflect light to a camera when properly aligned. This gives nanostars the appearance of twinkling at rates that can be precisely controlled by the speed of the rotating magnetic field. The unique signature of the twinkling nanostars enables them to be picked out easily from a field of stationary particles, some of which can be brighter than the nanostars. Any signal that doesn"t have the frequency corresponding to the rotating magnetic field can be suppressed in the images, eliminating background noise, Ritchie said. "It was surprising how well this method enhanced the imaging," he said. "It can improve the contrast of the particles to the background noise by more than 20 decibels and can clearly reveal a gyrating nanostar, where with existing direct imaging methods in many cases you wouldn"t be able to definitively find a particle." Gold nanostars and other gold nanoparticles have recently been examined as contrast agents for biomedical imaging because of their brightness at near-infrared wavelengths, which can penetrate through tissue better than visible light. However, giving them the ability to twinkle was key to developing a novel dynamic imaging method, Wei said. "Gyromagnetic nanostars combine strong optical signaling with a unique mechanism for reducing noise, allowing one to pick out the proverbial needle from the haystack," Wei said. "The key is to enable the nanostars to twinkle at a frequency of our choosing. Our analysis picks out signals at that frequency and translates that information into images of remarkable clarity." A paper detailing the team"s work is featured on the cover of the July 22 issue of the Journal of the American Chemical Society. In addition to Wei and Ritchie, co-authors include graduate students Qingshan Wei, Hyon-Min Song, Jacob A. Hale, Dongmyung Oh, Quy K. Ong and postdoctoral research associate Alexei P. Leonov. The National Institutes of Health funded the research. To perform gyromagnetic imaging, the team placed a sample of cells containing nanostars under a standard microscope equipped with a white light and a rotating magnet. Light was sent through a polarizing beam splitter and into the sample, then reflected back through the beam splitter and to the camera. The camera collected images at 120 frames per second, capturing the signal from the nanostars as they spun at approximately five revolutions per second. The set-up is simple and practical for general laboratory use, Ritchie said. "To translate a new imaging technique into something practical for broad use, it needs to be done without specialized equipment," he said. "Many other imaging techniques require expensive equipment or lasers, but this method can be done with a halogen lamp and a $10,000 camera." After initial data is collected, mathematical operations such as Fourier transforms can be applied to obtain frequency information from the pulsating light signals, allowing the twinkling nanostars to be easily picked out. The use of Fourier transforms in imaging techniques, often referred to as Fourier-domain imaging, is already known to be useful for reducing noise, but the research team"s method allows a mechanical frequency to be used as input for selective Fourier-based imaging, Wei said. "We have external control over the speed of rotation, so we will always know what frequency to focus on when looking for nanostars," he said. In testing whether nanostars might harm cells during the imaging process, the researchers found that the particles were not only biocompatible, but could actually promote cell growth, Wei said. The team is continuing to investigate the biological effects of nanostars inside cells. Writer: Elizabeth K. Gardner Elizabeth K. Gardner Purdue University


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