Trial of injectable flu drug yields disappointing results

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first_imgSep 20, 2007 (CIDRAP News) – BioCryst Pharmaceuticals, Inc, yesterday announced disappointing early results in a phase 2 study of its antiviral drug peramivir, which is seen as a potential new weapon against influenza.Peramivir is a neuraminidase inhibitor that, unlike the licensed antivirals oseltamivir (Tamiflu) and zanamivir (Relenza), is given by intravenous (IV) or intramuscular (IM) injection. Many countries have stockpiled oseltamivir, an oral drug, and zanamivir, inhaled as a powder, in the hope that they will help if the H5N1 virus evolves into a human pandemic strain.The phase 2 double-blind, placebo-controlled trial was designed to see if high doses of IM peramivir could reduce the duration of symptoms in patients with seasonal flu, BioCryst reported in a press release. The study involved 344 patients who had flu that was verified by rapid antigen testing. Patients were randomly assigned to receive injections of a placebo or either 150 mg or 300 mg of peramivir, administered in a single dose within 48 hours after symptom onset.With 313 patients available for evaluation, researchers found that the peramivir group improved more than placebo group, but the difference was not statistically significant, BioCryst reported. The improvement over placebo was 22.9 hours in the 150-mg dose group and 21.1 hours in the 300-mg group.The company said it believes the results were negatively affected by shorter needles—used for the phase 2 study but not for the phase 1 study—that may have delivered an adequate injection to only a third of the volunteers.In a post hoc analysis of 101 patients who received an adequate IM peramivir injection, as measured by elevated serum creatine kinase over baseline, investigators found that improvement over placebo was 64.6 hours in the 300-mg dose group and 44.6 hours in the 150-mg group.Safety and tolerability were similar for the placebo group and both peramivir groups, BioCryst said.”We’re clearly disappointed that we did not achieve the primary endpoint across the entire study population,” said Jon P. Stonehouse, president and chief executive officer of BioCryst, based in Birmingham, Ala., in the statement. However, he added the company was buoyed by the safety findings and said the efficacy findings in the patients that received an adequate dose exceeded expectations.BioCryst will correct the problems identified in the study when it launches a phase 3 study by the end of the year, he said.Another phase 2 study is under way to evaluate the efficacy of IV peramivir in hospital patients with flu, the company said. The study is designed to compare IV peramivir with oral oseltamivir.In January 2006 the US Food and Drug Administration (FDA) granted BioCryst a fast-track designation to develop an injection to treat highly virulent, life-threatening strains of influenza, the company said in its statement. In January 2007 the Department of Health and Human Services (HHS) awarded the company a $102.6 million contract to develop peramivir for seasonal and pandemic influenza.See also:Sep 19 BioCryst press releasehttp://investor.shareholder.com/biocryst/releasedetail.cfm?ReleaseID=264815Oct 2, 2006 CIDRAP News story “Injectable drug seen as potential treatment for flu, both seasonal and avian”last_img read more

Lakers’ Kobe Bryant has a mix of emotions, eager to write his comeback story

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first_imgA calming presence loomed around Kobe Bryant as he walked around the Lakers’ practice court, filming endless promotional spots and answering endless questions amid a swarm of people commanding his attention and time.But as the Lakers’ 2014-15 season officially started with the team’s media day on Monday at the team’s practice facility in El Segundo, the pleasant and smiling exterior masked Bryant’s conflicted emotions. Bryant remains only a season removed from when he played only six games because of injuries to his left Achilles tendon and left knee, a stretch that coincided with the Lakers finishing with their worst record in L.A. franchise history. “It’s a mixture of excitement, it’s a mixture of a little nervousness, it’s a mixture of rage,” Bryant said. “I’m trying to see if I can prove to myself that I can be myself. All those words and the doubts adds fuel to that.”Yet, the Lakers maintain optimism about Bryant. Beyond Bryant’s five NBA titles and extensive resume toward overcoming injuries, the Lakers also sound encouraged after seeing Bryant play in a five-on-five scrimmage last week at the team’s practice facility. Said Lakers rookie forward Julius Randle: “It looks like he hasn’t lost a step.” So much that Lakers coach Byron Scott gushed about Bryant’s shooting accuracy, post-up moves, rebounding and passing. Scott gushed about Bryant’s explosiveness even if he did not dunk. Scott also maintained Bryant’s “far from retiring.”Bryant will likely sit out of the Lakers’ four scheduled two-a-day sessions. But Scott provided little clarity on how many minutes Bryant will play after averaging 38 minutes the previous two seasons prior to his Achilles injury in April 2013. Still, Scott offered a bold prediction on how Bryant will play. “I expect him to play 82 games and to play well,” Scott said. “He’s a guy who’s still going to average 23-24 points per game. The biggest thing is for him to stay healthy and keeping his minutes to a minimum where he can play those 82 games.”Bryant downplayed his likely minute restriction, saying, “I don’t see it being much of an issue.” Bryant also hardly flinched on Scott’s optimistic assessment on his upcoming play. “It doesn’t matter,” Bryant said. “Offensively we’re going to be fine no matter what. It’s defense and rebounding that we need to focus on. I’m looking forward toward seeing how I move my feet defensively, staying in front of guys and chasing guys off of picks.” Newsroom GuidelinesNews TipsContact UsReport an Errorcenter_img The Lakers need plenty of help, finishing last season at the bottom of the league in nearly every defensive statistical category. “Our primary focus is to be great defensively,” Bryant said. “Offensively, I can always dictate what I’m going to do. Defensively it’s reacting to things. That’s a challenge that I really haven’t had to deal with this summer yet, so I’m looking forward toward seeing how I do.”Bryant sounded more sentimental about 40-year-old New York Yankees shortstop Derek Jeter recently playing his last game at Yankee Stadium with a game-winning single. Said Bryant: “The most touching moment for me was watching him walk off the field, walk through the tunnel and head back to the locker room.”Bryant sounded eager toward writing his own comeback story.“The size of the challenge that’s ahead of me has forced me to focus in more than I ever have,” said Bryant, who reportedly losing 10-12 pounds this summer. “It’s nutrition, training and everything. To play at this age with all the injuries, you have to have that focus.” last_img read more