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Bionovo's Estrogen Receptor Beta Selective Drugs Have Unique Gene Expression And Cell Type Specificity
Bionovo, Inc. (Nasdaq: BNVI) announced that a study of the gene regulation in multiple cell lines by several of their estrogen receptor beta (ERb) candidates will be published in Public Library of Science One.
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ARYx Therapeutics Announces Results Of Phase 2/3 Clinical Trial On Anticoagulant Agent Tecarfarin
ARYx Therapeutics, Inc. (NASDAQ:ARYX), a biopharmaceutical company, announced results from its Phase 2/3 clinical trial, EmbraceAC, comparing its novel anticoagulant agent tecarfarin (previously ATI-5923) with the leading oral anticoagulant warfarin. In this trial, tecarfarin demonstrated efficacy essentially the same as in earlier Phase 2 studies but did not achieve the primary endpoint of superiority over warfarin, as measured by time in therapeutic range (TTR). This was due to the virtually unprecedented performance of warfarin in this trial. Using the International Normalized Ratio (INR), which is the standard measure of anticoagulation to evaluate TTR, the patients in the trial who were administered tecarfarin stayed within the target therapeutic range 74.0% of the time treated as compared to those patients receiving warfarin who stayed within the target therapeutic range 73.2% of the time (p=0.506). The result for the warfarin group was unexpected based upon the extensive history of prior studies and published literature for the drug. Tecarfarin appeared to be well tolerated by the patients in this Phase 2/3 clinical trial.
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Insights Into Failed HIV-1 Vaccine Trial: Study
Following the disbandment of the STEP trial to test the efficacy of the Merck HIV-1 vaccine candidate in 2007, the leading explanation for why the vaccine was ineffective - and may have even increased susceptibility to acquiring the virus - centered on the hypothesis that high levels of baseline Ad5-specific neutralizing antibodies may have increased HIV-1 acquisition among the study subjects who received the vaccine by increasing Ad5-specific CD4+ T-cells that were susceptible to HIV-1 infection.
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Likelihood Of Survival May Be Improving For Extremely Preterm Infants

Infants born extremely preterm are surviving at a high rate, with about 70 percent of infants born alive between 22 and 26 weeks of gestation in Sweden surviving at least one year, with high rates of interventions being used to improve survival, according to a study in the June 3 issue of JAMA, a theme issue on child and adolescent health. Karel Maršál, M.D., Ph.D., of Lund University Hospital, Lund, Sweden, presented the findings of the study at a JAMA media briefing in New York. The rate of preterm births is increasing worldwide and advances in perinatal (relating to the period shortly before and after birth) medicine have increased survival so that neonatal (the newborn period, usually the first four weeks after birth) intensive care can today be life saving even for the most preterm infants. But the evidence for improved outcomes among extremely preterm infants, which is important for decision making before, during, and after birth, has been questioned, with there being a need for up-to-date information on infant survival. "ð€¦ misconceptions regarding outcomes may result in suboptimal perinatal care because chances for survival are underestimated," the authors write. Dr. Maršál and colleagues conducted a study to evaluate the short- and long-term outcomes of infants born before 27 gestational weeks in Sweden during 2004-2007. During the study period, 305,318 infants were born in Sweden; of these, 1,011 were extremely preterm infants (incidence, 3.3/1000 infants) born before 27 gestational weeks in 904 deliveries to 887 mothers, with 102 multiple births. Of the infants in the study, 707 were live-born and 304 stillborn. Overall survival at 1 year of age for infants born alive was 70 percent: for those born at 22 weeks it was 9.8 percent; at 23 weeks 53 percent; at 24 weeks 67 percent; at 25 weeks 82 percent; and at 26 weeks 85 percent. Of the 104 deaths occurring at least 24 hours after admission to a neonatal intensive care unit, 42 (40 percent) involved a decision to withdraw intensive care due to anticipated poor long-term prognosis. Among 1-year survivors, 45 percent had no major neonatal illness. "The most important finding in this study is the high survival of extremely preterm infants born alive. Survival rates at hospital discharge in recent population-based studies have been reported as 0 percent at 22 weeks, 6 percent to 26 percent at 23 weeks, and 29 percent to 55 percent at 24 weeks," the authors write. The overall perinatal death rate was 45 percent, ranging from 93 percent at 22 gestational weeks to 24 percent at 26 weeks. Of live-born infants, 152 (22 percent) died during the early neonatal period (0-6 days) including 58 (8.2 percent) who died in the delivery room; and 35 (5 percent) who died during the late neonatal period (7-27 days). Altogether, 210 live-born infants (30 percent) died before the age of 1 year. The proportion of stillbirths, delivery room deaths, neonatal deaths, and infant deaths decreased with gestational age. For infants who survived 28 days, no significant association between gestational age at birth and 1-year survival could be detected. Antenatal (occurring before birth) treatment with tocolytics (a drug that delays or halts labor), corticosteroids, or both; surfactant (a fluid that is produced shortly before birth and prevents the lung from filling with water) treatment within 2 hours after birth; and birth at a level III hospital were significantly associated with lower risk of infant death. "In summary, overall 1-year survival was 70 percent in extremely preterm infants born alive at 22 to 26 weeks of gestation in Sweden during 2004-2007. Proactive perinatal management is likely to have contributed to this outcome. Therefore, non-initiation or withdrawal of intensive care for extremely preterm infants cannot be based solely on a notion of unlikely survival. This is not to suggest that all extremely preterm live-born infants should be kept alive at any cost. The prognosis, based on an individual assessment, including early and subsequent morbidities, and parental desires are still the most important factors in decision making," the authors conclude. JAMA. 2009;301[21]:2225-2233 Journal of the American Medical Association


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