Encouraging results reported for injectable flu drug

first_img Sheridan said no significant differences in any of the efficacy end points were seen, which “was expected given the active control, small sample size, and exploratory phase 2 nature of this study.” Oct 28 news release about outpatient studyhttp://investor.shareholder.com/biocryst/ReleaseDetail.cfm?ReleaseID=343466 In the other trial, hospital patients who were seriously ill with flu were treated for 5 days with either IV peramivir or oseltamivir, with similar results in both groups, including no deaths and a median of 4.0 days to hospital discharge, the company said. Oct 27 news release about hospital studyhttp://investor.shareholder.com/biocryst/ReleaseDetail.cfm?ReleaseID=343132 Clinical stability was a composite measure based on temperature, oxygen saturation, respiratory rate, systolic blood pressure, and heart rate. For ethical reasons, the study included no placebo arm. In addition, both peramivir groups had significant improvements in a composite symptoms score, starting as early as 24 hours after treatment, the statement said. The drug was well-tolerated, with adverse-event profiles similar for the treatment and placebo groups. Hospital studyThe inpatient study was designed primarily to assess how long it would take patients with serious or life-threatening flu to become clinically stable with 5 days of treatment with peramivir or oseltamivir. The study was conducted at centers in the United States, Canada, Hong Kong, Singapore, Australia, New Zealand, and South Africa. “This phase 2 study was a critical test of peramivir, which demonstrated for the first time that a single administration of this potent neuraminidase inhibitor can be effective in treating seasonal influenza,” Dr. William P. Sheridan, chief medical officer of BioCryst, said in the news release. Secondary outcomes for all groups included no mortality, no clinical relapse, a median of 4.0 days to hospital discharge, and a median of 10.8 days to resumption of normal activities, the company reported. Sep 20, 2007, CIDRAP News story “Trial of injectable flu drug yields disappointing results” Sheridan also said that the zero mortality in the study is “an important finding worthy of follow-up,” given that a previous epidemiologic study showed a mortality rate of 10% in 219 patients who were not treated with neuraminidase inhibitors. See also: Page with link to recording of Oct 27 BioCryst teleconference (free registration required)http://investor.shareholder.com/biocryst/eventdetail.cfm?eventid=60565 Peramivir is a neuraminidase inhibitor, like the licensed antivirals oseltamivir (Tamiflu), which is taken orally, and zanamivir (Relenza), inhaled as a powder. In response to questions, he said the study was not designed to show differences between peramivir and oseltamivir. He said peramivir is important because it permits parenteral treatment of flu patients, adding, “At the ICAAC meeting the need for a parenteral drug for influenza has come up several times already. Also there’s concern about resistance to existing drugs, including oseltamivir.” The primary end point was time to alleviation of symptoms, which was 81.8 hours for the placebo group. The respective times for the 300-mg and 600-mg peramivir groups were 59.1 and 59.9 hours, both of which were significant reductions, the company said. Oct 31, 2008 (CIDRAP News) – BioCryst Pharmaceuticals Inc. reported encouraging results this week in two phase 2 trials of its injectable antiviral drug, peramivir, a potential new treatment for influenza. In one study, a single intravenous (IV) dose of peramivir in outpatients ill with flu reduced the duration of their symptoms by about 22 hours compared with a placebo group, a statistically significant difference, according to BioCryst, based in Birmingham, Ala. Neither set of results has yet been published in a peer-reviewed journal. The company described the inpatient study in a press release and a teleconference on Oct 27; the outpatient study was reported in an Oct 28 press release and a poster presentation at the 46th Interscience Conference on Antimicrobials and Chemotherapy/Infectious Diseases Society of America (ICAAC/IDSA) meeting this week in Washington, DC. Outpatient findingsThe outpatient study was sponsored and conducted in Japan by Shionogi & Co. Ltd., which in 2007 bought from BioCryst the rights to develop and market peramivir in Japan. “The time to clinical stability was 25.3 hours for all groups combined, with no statistically significant differences across treatment groups,” Sheridan reported during the Oct 27 conference call (a recording of which is available online). In the news release, Dr. Michael Ison of Northwestern University, principal investigator in the study, said, “This landmark study provides us great insight into the course of treatment for patients who are hospitalized for influenza. The results indicate a potential role for antiviral therapy, which is critical as currently there are no antivirals approved for patients hospitalized for acute serious or potentially life-threatening influenza.” The new findings come 13 months after the company reported disappointing results in an earlier phase 2 trial of the drug. In that study, flu patients who received injections of peramivir did better than a placebo group, but the difference was not significant. The company said at the time that the use of shorter needles than were used in an earlier trial probably resulted in inadequate doses. The study involved 296 patients who tested positive for influenza within 48 hours after symptom onset, BioCryst reported. The volunteers were divided into three groups, with 99 receiving 300 milligrams (mg) of peramivir IV, 97 receiving 600 mg of the drug IV, and 100 receiving an IV placebo. The investigators enrolled 122 patients who had flu confirmed by polymerase chain reaction. Of these, 41 received 75 mg of oseltamivir twice daily, 41 received 200 mg of IV peramivir twice daily, and 40 received 400 mg of IV peramivir twice daily.last_img read more

Kids aren’t coronavirus ‘guinea pigs’: Danish mums rebel as schools reopen

first_imgBut any new infections would be unproblematic in an age group “where few fall ill, and those who do won’t get very sick”.Looking at neighbouring Sweden, which has kept schools open without a drastic rise in infections, children also appeared not to be a major driver for transmission of the virus, he said.Teaching staff are under instruction to keep social distancing in place between children and, with many school buildings staying closed, in some cases preparing chalk for pupils to write with on the playground tarmac.”I don’t think it’s right for the kids not to hug their friends,” said Nonne Behrsin Hansen, a mother of two aged two and four.”We keep the kids home, because the situation in the daycares before the COVID-19 outbreak were not okay, and the conditions they are setting up now are even worse.”For now at least, most members of Momster, an online network of thousands of Danish mothers, do not believe authorities have things under control, according to its founder and CEO Esme Emma Sutcu.”Suddenly, these moms feel like they just have to throw their kids to the frontline and I think their reaction is: ‘Don’t mess with our kids’,” she said.Topics : “I think a lot of parents are thinking, ‘Why should my little child go outside first’,” said the mother of two girls aged five and nine.The month-long lockdown in Denmark, where the virus has infected more than 6,600 people with close to 300 deaths, has also closed shops, bars, restaurants, cinemas and gyms.On Wednesday, Prime Minister Mette Frederiksen defended the move, undertaken on health authority recommendations, to ease it by resuming teaching up to fifth grade, saying this would allow parents to return to work and “get the economy going again.”Christian Wejse, a scientist at the department of infectious diseases at Aarhus University, said he understood people’s concerns “because we’ve spent a month trying to avoid contact.” Denmark eased its coronavirus lockdown on Wednesday by reopening schools and day care centers, but concerns they might become breeding grounds for a second wave of cases convinced thousands of parents to keep their children at home.The rate of new cases is falling, but the government’s decision has led to a heated debate over how to balance the needs of the economy and the safety of the population – in this case its youngest citizens.”I won’t be sending my children off no matter what,” said Sandra Andersen, the founder of a Facebook group called ‘My kid is not going to be a Guinea Pig’ that has more than 40,000 followers.last_img read more

Humberto becomes hurricane in record time, surprises Texas

first_imgSurprising as Humberto was, forecasters said it may have been a blessing that it didn’t linger longer over warm waters of the Gulf of Mexico, which could have given it time to develop into more than a minimal hurricane. Texas coastal residents prepared for a tropical storm rainmaker that would quickly flood the ground already saturated from the wettest summer in 60 years. Although forecasts called for up to a foot of rain, Humberto produced no more than half that and generated much more wind. By late afternoon, it had weakened to tropical depression churning across the Deep South. “We feel very fortunate and blessed it wasn’t worse,” said Beaumont resident Edward Petty, 50, who was clearing debris outside his home 50 miles northeast of High Island, near where the storm came ashore. “It was amazing to go to sleep to a tropical storm and wake up to a hurricane,” he said. “What are you going to do? You couldn’t get up and drive away. You couldn’t run for it. You just have to hunker down.” The only reported death was a man who died in southeast Texas when the carport at his home collapsed, police said. Humberto made landfall less than 50 miles from where Hurricane Rita did in 2005, and areas of southwest Louisiana not fully recovered from Rita were bracing for more misery. “I’m in a FEMA trailer (because of Rita) and I’m on oxygen,” said Albertha Garrett, 70, who spent the night at a shelter in the Lake Charles Civic Center. “I had to come to the civic center just in case the lights would go out, because I’m alone and I’m handicapped.” Along Port Arthur’s refinery row, three plants were idled until power was restored. Some of the plants could be off-line for several days, even after power is restored, because they must undergo the full restart process. Hurricane center forecasters first mentioned what would become Humberto on Saturday, when it was a disorganized system of showers and thunderstorms stretching from Cuba west over the southern Gulf of Mexico. By 11 a.m. Wednesday, it had organized into a tropical depression with 35 mph winds and by 2 p.m. was a 45-mph tropical storm, centered just 70 miles off shore. At 1:15 a.m. Thursday, it was upgraded to an 80-mph, Category 1 hurricane, only 15 miles from the coast. Less than two hours later, at 3 a.m., its center roared ashore with 85-mph winds just east of High Island. Only three other storms have pulled off a similar feat, growing from depression to hurricane in 18 hours – Blanche in 1969, Harvey in 1981 and Alberto in 1982 – but all of them were out at sea at the time, not about to crash ashore like Humberto.160Want local news?Sign up for the Localist and stay informed Something went wrong. Please try again.subscribeCongratulations! You’re all set! HIGH ISLAND, Texas – Call it the instant hurricane. Humberto, which grew faster than any storm on record from tropical depression to full-scale hurricane landfall, surprised the Texas-Louisiana coast early Thursday with 85-mph winds and heavy rain that knocked out power to more than 100,000 and left at least one person dead. Meteorologists were at a loss to explain the rapid, 16-hour genesis of the first hurricane to hit the U.S. since 2005. “Before Humberto developed, you looked at the satellite imagery the day before, and there was virtually nothing there. This really spun up out of thin air, very, very quickly, said National Hurricane Center specialist James Franklin in Miami. “We’ve never had any tropical cyclone go from where Humberto was to where Humberto got.” last_img read more