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RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)-- BioCryst Pharmaceuticals, Inc.(NASDAQ: BCRX) today announced the presentation of data related to intravenous (i.v.) peramivir for the treatment of influenza at the 51st Annual Interscience Conference on Antimicrobial Agents & Chemotherapy(ICAAC) in Chicago, Illinois.
Data from the Company's completed Phase 3 safety and virology study—one of the largest, prospective studies of an influenza anti-viral in the hospital setting completed to date—will be presented as an oral presentation today,
September 17, 2011at 4:45 p.m. Central Time. The study was an open-label, randomized trial of the anti-viral activity, safety and tolerability of i.v. peramivir administered either as a once-daily infusion of 600 mg or a twice-daily infusion of 300 mg to adult and adolescent patients hospitalized with confirmed or suspected influenza infection. Treatment was planned for 5 days with an extension to 10 days in patients who needed additional treatment. Top-line results from this study were announced in January 2011.
The oral presentation "Safety and Anti-viral Effect of Multi-Day Therapy with IV Peramivir 300 mg BID or 600 mg QD in Hospitalized Influenza Subjects" (Presentation Number V-402) concludes that the two regimens studied were generally safe and well-tolerated in patients hospitalized with influenza. Furthermore, no differences were observed between the two groups for the primary virology endpoint, which was the change (reduction) in influenza virus titer measured by log10 tissue culture infective dose (TCID50), as well as for the secondary virology endpoint studied (change from baseline in quantitative Polymerase Chain Reaction [QPCR]). There were no meaningful differences between the groups with respect to the other clinical or virologic endpoints.
In addition to the oral presentation, BioCryst will be presenting the data from the following human safety and virology studies during a poster session scheduled for
Monday, September 19, 2011from 11:15-1:15 p.m. Central Time. The two posters to be presented during the session include:
- Presentation Number V-1541: "No Evidence of Resistance of Influenza Viruses After 5-Day IV Peramivir Therapy in Hospitalized Patients"
- Presentation Number V-1556: "Comparison of Tissue Culture Infective Dose (TCID50) and Quantitative PCR (QPCR) in the Diagnosis and Follow Up of Influenza Hospitalized Subjects"
Copies of the abstracts are available and can be viewed online through the ICAAC website at www.icaac.org. The oral presentation and posters will be uploaded to the BioCryst website upon completion of the sessions to abide by the conference's embargo policy. Please refer to the Company's peramivir publications page.
Peramivir is a potent, intravenously administered investigational anti-viral agent that rapidly delivers high plasma concentrations to the sites of infection. Discovered by BioCryst, peramivir inhibits the interactions of influenza neuraminidase, an enzyme which is critical to the spread of influenza within a host. In laboratory tests, peramivir has shown activity against multiple influenza strains, including pandemic H1N1 swine origin flu viral strains. In
January 2010, Shionogi & Co., Ltd.launched intravenous (i.v.) peramivir in Japanunder the name RAPIACTA® to treat patients with influenza and in August 2010, Green Cross Corporation announced that it had received marketing and manufacturing authorization for i.v. peramivir in Koreato treat patients with influenza A & B viruses, including H1N1 and avian influenza.
Peramivir is currently being developed under a
$234.8 millioncontract from the Biomedical Advanced Research and Development Authority(BARDA) within the United States Department of Health and Human Services(HHS).
BioCryst Pharmaceuticalsdesigns, optimizes and develops novel small-molecule pharmaceuticals that block key enzymes involved in infectious diseases, inflammatory diseases and cancer. BioCryst currently has three novel late-stage compounds: peramivir, a neuraminidase inhibitor for the treatment of influenza, BCX4208, a purine nucleoside phosphorylase (PNP) inhibitor for the treatment of gout, and forodesine, an orally-available PNP inhibitor for hematological malignancies. Utilizing crystallography and structure-based drug design, BioCryst continues to discover additional compounds and to progress others through pre-clinical and early development to address the unmet medical needs of patients and physicians. For more information, please visit the Company's website at www.biocryst.com.
This press release contains forward-looking statements, including statements regarding future results, performance or achievements. These statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Some of the factors that could affect the forward-looking statements contained herein include: that there can be no assurance that our compounds will prove effective in clinical studies; that development and commercialization of our compounds may not be successful; that HHS may further condition, reduce or eliminate future funding of the peramivir program; that we or our licensees may not be able to enroll the required number of subjects in planned clinical trials of our product candidates and that such clinical trials may not be successfully completed; that BioCryst or its licensees may not commence as expected additional human clinical trials with our product candidates; that our product candidates may not receive required regulatory clearances from the
FDA; that ongoing and future pre-clinical and clinical development may not have positive results; that we or our licensees may not be able to continue future development of our current and future development programs; that our development programs may never result in future product, license or royalty payments being received by BioCryst; that BioCryst may not be able to retain its current pharmaceutical and biotechnology partners for further development of its product candidates or it may not reach favorable agreements with potential pharmaceutical and biotechnology partners for further development of its product candidates; that our actual cash burn rate may not be consistent with our expectations; that BioCryst may not have sufficient cash to continue funding the development, manufacturing, marketing or distribution of its products and that additional funding, if necessary, may not be available at all or on terms acceptable to BioCryst. Please refer to the documents BioCryst files periodically with the Securities and Exchange Commission, specifically BioCryst's most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and current reports on Form 8-K, all of which identify important factors that could cause the actual results to differ materially from those contained in our projections and forward-looking statements.
BioCryst Pharmaceuticals Robert Bennett, 919-859-7910 (investors)
Catherine Collier Kyroulis, 212-301-7174 (media)
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