Did Tami ever produce stat sig numbers similar or better than the following?
++++++++++++++++
BioCryst Reports Positive Results From a Phase 2 Study of Intravenous Peramivir for Outpatient Influenza
prnews
A Single Dose of Peramivir is Effective and Well-Tolerated at Both 300 mg and 600 mg Dose Levels
BIRMINGHAM, Ala., Oct. 28 /PRNewswire-FirstCall/ -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that a double-blind, placebo-controlled, Phase 2 study of intravenous (i.v.) peramivir, administered via a single dose injection in outpatients with acute, uncomplicated influenza, met its primary endpoint of time to alleviation of symptoms for both the 300 mg dose (p=0.0046) and 600 mg dose (p=0.0046). The study was sponsored by BioCryst's partner for peramivir, Shionogi & Co., Ltd.
The poster titled, "A Double-Blind, Placebo-Controlled Study of Intravenous Peramivir in Acute Influenza Patients" (Poster Session # 302: Respiratory Viruses I: Influenza and RSV) will be presented on Tuesday, October 28 from 12:15 p.m. - 1:15 p.m. Eastern Time in Hall C by Dr. Shigeru Kohno, Dean, Nagasaki University Graduate School of Medicine and Professor, Infection Immunology Department, Nagasaki University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences.
"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," said Dr. William P. Sheridan, Chief Medical Officer of BioCryst. "The promising data in outpatient influenza highlights the potential of the compound as a novel and effective influenza therapy and we look forward to learning more about the clinical advantages of peramivir in the upcoming Shionogi-sponsored Phase 3 program."
The randomized, double-blind, placebo-controlled, Phase 2 study conducted in Japan enrolled 300 patients age 20 to 64, who 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 rights were extended to include Taiwan. In 2007, BioCryst received a $14 million up-front payment and may also receive future clinical event milestone payments (up to $21 million) and commercial event milestone payments (up to $95 million) in addition to double-digit (between 10 percent and 20 percent range) royalty payments on product sales of peramivir. BioCryst retains all rights to commercialize peramivir in North America, Europe and other countries outside of Japan, Taiwan and Korea.
About Peramivir
[SNIP] |
