Health & Fitness
Health and Fitness
Health and Fitness
Thu, October 21, 2010
BioCryst to Present New Clinical & Virologic Data for I.V. Peramivir at the 48th Annual IDSA Meeting
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 48th Annual Infectious Diseases Society of America (IDSA) meeting being held in Vancouver, Canada.
"Neutropenia Is Not Related to Neuraminidase Inhibitor (NAI) Therapy of Uncomplicated Influenza in Phase 2 and 3 Controlled Clinical Trials"
The data will be presented during a poster session scheduled for Friday, October 22, 2010 from 12:30-2:00 p.m. Eastern Time. The two posters to be presented during the session include:
- Presentation Number 761: aClinical and Virologic Outcomes with Peramivir Therapy in Hospitalized Adults with Influenza B: Sub-Group Analysis of a Phase 2 Trial,a which concludes that peramivir and oseltamivir treatment resulted in similar clinical outcomes in the overall study population (N=137). However, in the sub-group of influenza B infected patients (N=32), peramivir treatment resulted in significantly faster reduction of viral replication and showed a trend to more rapid normalization of clinical outcomes compared to oral oseltamivir treatment. The resumption of normal activities four days earlier in the peramivir-treated subjects may be a clinically meaningful outcome. These findings may reflect superior anti-viral activity of peramivir compared to oseltamivir against influenza B and should be further investigated.
- Presentation Number 765: aNeutropenia Is Not Related to Neuraminidase Inhibitor (NAI) Therapy of Uncomplicated Influenza in Phase 2 and 3 Controlled Clinical Trials,a which describes the effects of influenza infection on lymphocyte and neutrophil populations and concludes that in placebo- or oseltamivir-controlled trials, peramivir has no apparent effects on leukocyte counts or risk of neutropenia in patients with influenza. Results were drawn from an analysis of data from five Phase 2 and Phase 3 clinical trials which included over 2,200 influenza patients treated with peramivir or a control.
Copies of the abstracts are available and can be viewed online through the IDSA Web site at [ www.idsociety.org/ ].
About peramivir
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 Japan under 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 South Korea to treat patients with influenza A & B viruses, including H1N1 and avian influenza. For more information about peramivir please visit BioCrysta™s Web site at [ http://www.biocryst.com/peramivir ].
About BioCryst
BioCryst Pharmaceuticals designs, 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 in development: 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 forhematological 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 Web site at [ www.biocryst.com ].
Forward-Looking Statements
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 to the extent peramivir is used as a treatment for H1N1 flu (or other strains of flu), there can be no assurance that it will prove effective; that HHS may further condition, reduce or eliminate future funding of the peramivir program; that ongoing peramivir clinical trials or our peramivir program in general may not be successful; 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.
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