BioCryst Reports Positive Results From a Phase 2 Study of Intravenous Peramivir for Outpatient... (tested positiveby rapid antigen test (RA...)

BioCryst Reports Positive Results From a Phase 2 Study of Intravenous Peramivir for Outpatient Influenza

Date:10/28/2008

tested positive by rapid antigen test (RAT) for influenza within 48 hours of symptom onset. Of the 300 patients randomized, 296 were included in the intent-to-treat infected population; 99 received 300 mg peramivir i.v., 97 received peramivir 600 mg i.v. and 100 received placebo i.v. The primary endpoint of the study was time to alleviation of symptoms. Other endpoints included change from baseline in composite symptom score, time-weighted change in influenza virus titers from baseline to two days following infusion, pharmacokinetics and safety.

Both doses of peramivir significantly reduced the time to alleviation of symptoms in influenza patients by 32 to 33 percent compared to placebo: hazard ratios were 0.681 for 300 mg dose and 0.666 for the 600 mg dose (adjusted p=0.0046 for both comparisons). The median time to alleviation of symptoms was 59.1 hours for those receiving the 300 mg dose, 59.9 hours for those receiving the 600 mg dose and 81.8 hours for those receiving placebo. In addition, change from baseline in the composite symptom score was significantly improved in both the peramivir 300 mg and 600 mg arms compared to the placebo arm, as early as 24 hours after the start of treatment (p=0.0032 and p=0.0109, respectively). There was a significant difference between peramivir 600 mg and placebo in time-weighted change in influenza virus titers from baseline to two days following infusion (p=0.0027). Peramivir was generally well-tolerated, with an adverse event profile similar to that of placebo. Pharmacokinetic profiles of i.v. peramivir in influenza patients were similar to those seen in healthy subjects.

About the Shionogi & Co., Ltd. Partnership

In February 2007, BioCryst and Shionogi & Co., Ltd. entered into an exclusive license agreement under which Shionogi obtained rights to develop and commercialize peramivir in Japan for the treatment of seasonal and potentially life-threatening human influenza. Earlier this year, Shionogi's rig
'/>"/>

0

GOOD

Page: 1 2 3 4 5
Related medicine news :

1. BioCryst Pharmaceuticals to Announce First Quarter 2008 Financial Results on May 8, 2008
2. BioCryst to Release Third Quarter 2007 Financial Results on Thursday, November 8, 2007
3. Cynosure Reports 21% Revenue Growth for the Third Quarter of 2008
4. LCA-Vision Reports Third Quarter 2008 Financial Results
5. Universal Health Services, Inc. Reports 2008 Third Quarter Results
6. PAREXEL Reports First Quarter Fiscal Year 2009 Financial Results
7. Sharps Compliance Corp. Reports Net Income More Than Doubles on 26% Increase in Revenue in the First Quarter of Fiscal 2009
8. WellPoint Reports Third Quarter 2008 Results
9. Forest Laboratories, Inc. Reports Fiscal Second Quarter 2009 Earnings per Share of $0.80
10. Schering-Plough Reports Financial Results for Third Quarter of 2008
11. Quest Diagnostics Reports Growth in Revenue and Earnings for Third Quarter 2008

Post Your Comments:

BioCryst Reports Positive Results From a Phase 2 Study of Intravenous Peramivir for Outpatient...(tested positiveby rapid antigen test (RA...),Health