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.
Read More | Hardik Pandya, KL Rahul issued showcause notice by BCCIPandya took to his Twitter handle and issued the apology after his comments raised a massive controversy on social media, with several users labeling it ‘misogynistic’ and ‘racial’. The apology is related to a particular part where he passed some distasteful comments on women and his sexual activities on television.Someone please tell Hardik Pandya that what he thinks is a ‘cool-idgaf-badboy’ image comes out as nothing but creepy and gross.— n. (@FeistyFangirlx) January 6, 2019Read More | Hardik Pandya issues apology for ‘misogynistic’, ‘racist’ commentsThe situation came into light with this one conversation when Johar was asking questions about not asking women’s name in a night club and what do men talk about. To this, Pandya replied, “I like to watch and observe how they (women) move. I’m little from the black side so I need to see how they move.” Pandya also boasted about how he casually discussed his sex life with his parents. “When I lost my virginity, I came home and said, ‘Main karke aya hai aaj (I had sex today)’. At a party my parents asked me ‘acha tera wala (women) kaun sa hai [who is your interest here?] so I said yeh, yeh, yeh (pointing out women)’ and they were like ‘waah proud of you beta’,” Pandya replied with laughter. During the time when the #MeToo movement is active and sexual harassment is a serious issue which needs to be tackled in all fields, the comments from Pandya did not go down well with Twitter users labeling his comments ‘gross’ and a ‘big disappointment’. In his apology, Pandya has admitted that he got ‘carried away’.While Pandya’s comments have drawn plenty of flak, it must be observed that Rahul, who was the other guest in the program, responded with straight answers and showed his dignity. When asked about a situation if both like the same woman , Rahul responded, “It is upto the woman.” Pandya, in turn, responded, “Nahi nahi aisa kuch nahi hai, talent pe hota hai. Jisko mila woh leke jao (No, no, it is nothing like that. It is all on talent. Whoever gets it, take her away). It is on talent.” New Delhi: Hardik Pandya, the India allrounder, could reportedly be banned by the Board of Control for Cricket in India following his controversial remarks on Koffee With Karan, a talk show hosted by popular bollywood director Karan Johar. According to several media reports, Pandya could be banned for two games, putting his participation in the Australia series, beginning on January 12 at the Sydney Cricket Ground in jeopardy. Reports have further stated that the recommendation to ban Pandya for two games has come from the head of the Committee of Administrators, Vinod Rai. The reports further state that the CoA is waiting for the approval of Diana Edulji for the bans to take effect. Speaking to PTI, Rai said he was not convinced with the explanation provided by Pandya and has recommended such measures.Pandya’s remarks were slammed as ‘misogynistic’, ‘racist’ by many Twitter users and the Board of Control for Cricket in India also jumped him, issuing a showcause notice to the all-rounder along with KL Rahul, the other cricketer present on the show. Pandya had taken to Twitter to apologise for his remarks and apparently, he has also expressed ‘regret’ over the comments when he responded to the showcause notice. The all-rounder has said the mistake will not be repeated in the future.In a report on PTI, Pandya was not part of the optional practice session at the Sydney Cricket Ground and has apparently spoken to Ravi Shastri and other senior members of the Indian cricket team. “I made an appearance on the chat show where I have made certain statements without realising that these could be disrespectful and offend sensitivities of viewers for which I am sincerely regretful. I would like to assure you that there was no malice or any sort of ill-intent on my part to offend anyone or portray any section of the society in bad light. I made these statements in the flow of the show and had not comprehended the extent to which my statements would be found offensive,” Pandya responded in a query which was in possession with PTI. For all the Latest Sports News News, Cricket News News, Download News Nation Android and iOS Mobile Apps.