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

Nandlall fires back at AG

first_imgHWLS placement debacleFormer Attorney General and Legal Affairs Minister Anil Nandlall has yet again lashed out at current LegalFormer AG Anil NandlallLegal Affairs Minister Basil WilliamsAffairs Minister Basil Williams over what he said are his controversial comments about the former AG’s role.Williams, at a recent press conference said it was the former People’s Progressive Party (PPP) Government which caused the current state of affairs in the country. Williams blamed the previous Administration for failing the Guyanese law students, and for not giving special interest in the programme and its commitment with the Trinidad and Tobago-based Hugh Wooding Law School.In a social network post on Tuesday, Nandlall rebuffed the statement made by the Attorney General, and in fact laid out that he (Nandlall), who had responsibility for the programme at the time, had been very much consistent in every endeavour to ensure students be successful getting into the HWLS.“In 2014, I along with the then Head of the Department of Law, University of Guyana, successfully negotiated, on behalf of the Government of Guyana, the terms of a new agreement with officials of the University of the West Indies [UWI] and the Council of Legal Education [CLE] of the West Indies, for the continued automatic admissions of graduates of the UG Law Programme into the Hugh Wooding Law School,” Nandlall stated.Nandall said this became necessary since the previous agreement entered into by his predecessor had come to an end through “effluxion of time”. He stated that the entire initiative was a PPP/C Government one which began in 1996.“Two previous such agreements had expired. The responsibility became mine to negotiate and conclude the third. When the negotiations started, several members of CLE/UWI team argued against non-renewal of the agreement. We defeated this argument. They next argued for a reduction of the quota of 25. We again defeated this argument. In the end, not only did we succeed in retaining the quota of 25 for Guyanese nationals graduates but were able to secure an additional 10 places for non-Guyanese nationals graduates of the said Law programme,” he explained.This agreement, he said, was to be signed before September 2015 to regulate the admission of students for the year 2015-2016 to the Law School. He said he left office in May of 2015, and upon his departure, he did brief Williams.“I explained to him that the hard work is finished and that all he needs to do is to ensure that the agreement which was being drafted by UG And UWI be signed and taken to the CLE for their signature because it is a tripartite agreement.”However, a year later, Nandlall said he is now reading in the press that Williams has disclosed that the agreement has not yet been signed.“What is worse, rather than remain silent or admit to his utter incompetence, he blames, the previous Government and the Council of Legal Education for this predicament. To further conceal his ineptitude, he throws a red herring into the equation about building a local school. Even if that’s a feasible option, it will take years to materialise. What will happen to students in the meantime? That’s the issue; why after one year, the negotiated agreement has not been signed? I ask again, for how long will the nation endure such incompetence?” Nandlall asked.Williams had told journalists that Government remained concerned about the situation in which students have found themselves and was working to have it settled.Williams said the decision by the former People’s Progressive Party/Civic (PPP/C) Administration to discontinue contributions to the HWLS is responsible for the dilemma facing Guyanese law students.“I could tell you that they all (HWLS) feel that because we don’t pay and contribute, it is unfair for us to have our students taking up places at the school,” Williams said.According to him, the problem was further “aggravated” because all the campuses of the University of the West Indies are doing the full law degree just as the University of Guyana, and have hundreds of students who also want to enter into the programme.“It is a question of the discontinuance of paying any contribution whatsoever, and we inherited that situation and are trying to address it. But all we seem to have done is to encourage a lot of problems”.The previous PPP/C Administration fought ‘tooth and nail’ in recent years to ensure that the top 25 University of Guyana law students are accepted in the Hugh Wooding Law School.As a matter of fact, in 2013, then Caribbean Community (Caricom) Chairman, Dr Ralph Gonsalves had the cause to write the University of the West Indies Council for Legal Education on the impasse over Guyanese law students being accepted at the Trinidad-based Hugh Wooding Law School.last_img read more

Muyoti fumes at loss to Gor’s ‘weakest team ever’

first_img“I am very disappointed with how we played today. We conceded two goals from long throws because of concentration lapses. This Gor side is one of the weakest they have ever fielded in this league and it is sad we lost,” the tactician offered.The tactician blamed his players for failing to sustain pressure and also offered that his frontline was not as creative as he would have wished.“We were under pressure and that’s when I expect my players to be cool, calm and collected but we were not. Our attack was blunt and we didn’t create much infront of goal,” Muyoti further stated.Kakamega Homeboyz striker Allan Wanga attempts to go past Gor Mahia’s Harun Shakava and Geoffrey Ochieng during their Kenyan Premier League match at the Kenyatta Stadium in Machakos on March 14, 2019. PHOTO/Timothy OlobuluLooking into the transfer window, the tactician who recently joined Homeboyz from Nzoia Sugar says the club is looking out for three new players; a keeper, defensive midfielder and a left footed winger.Homeboyz hope to quickly shrug off the disappointment of losing out to Gor when they take on Mathare United at the Bukhungu Stadium on Sunday.While Homeboyz are looking to get their feet back in for a top half race, fourth placed Mathare will be aiming their efforts at getting back to the top of the standings.Mathare are on 31 points, two behind leaders Sofapaka and victory in Kakamega will hoist them to the top with 34 points.0Shares0000(Visited 1 times, 1 visits today) 0Shares0000Kakamega Homeboyz head coach Nicholas Muyoti (left) listens to a member of his technical bench during a past Kenyan Premier League match. PHOTO/Timothy OlobuluNAIROBI, Kenya, Mar 15 – Kakamega Homeboyz head coach Nicholas Muyoti was left fuming at his players after they let go of a single goal lead to lost 2-1 to a Gor Mahia side he described as the weakest they have ever fielded.Two goals in two minutes saw an under strength Gor side which had only four players on the substitute’s bench come from behind to win and move second in the standings.last_img read more