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Biotech / Medical : Aviron -- Ignore unavailable to you. Want to Upgrade?

To: Dennis who wrote (292)	8/10/1998 10:11:00 AM
From: Dennis	Respond to of 645

GREAT NEWS SHOULD BE POSTED TO THE THREAD: avir To print this story Headlines Next Story Aviron Announces Commencement of First Study to Assess Widespread Pediatric Influenza Vaccination PR Newswire - August 06, 1998 11:20 MOUNTAIN VIEW, Calif., Aug. 6 /PRNewswire/ -- Aviron (Nasdaq: AVIR) announced today the start of a large, multi-year clinical trial to assess the impact of community-wide pediatric influenza immunization. The trial, to take place in Temple, TX, is expected to involve about 15,000 vaccinated children and is funded by a $3 million grant from the National Institute of Allergy and Infectious Diseases of the National Institutes of Health (NIAID/NIH) and awarded to Baylor College of Medicine. The trial will be conducted by the Scott and White Hospital and Clinic in Temple, TX, Baylor College of Medicine in Houston and the Texas Department of Health. The non-randomized, open-label study will evaluate the impact of vaccinating preschool and school-age children with FluMist(TM) intranasal influenza vaccine based on the incidence of doctor visits for flu and flu-related illnesses. The large number of trial participants will also provide additional information on vaccine safety. All healthy children in Temple between the ages of 18 months and 18 years will be eligible to participate in the three-year trial. During each flu season, which typically lasts from November to March, researchers will monitor health-care visits in the Temple area using clinic and HMO databases. The number of flu-related clinic visits will then be compared to a similar HMO population in Texas, where FluMist(TM) will not be administered. "This study represents an important step in understanding the impact on an entire community when a key segment of the population is vaccinated against influenza," stated J. Leighton Read, M.D., chairman and chief executive officer of Aviron. "Since children play a key role in the spread of influenza, we hope that high levels of vaccine coverage in children will have benefits for kids as well as others in the population." Epidemic influenza affects approximately 10-20 percent of the United States population each year, resulting in 35-50 million cases of the illness and approximately 20,000 deaths. By the age of 5, most children have had the flu three or more times. FluMist(TM) has been tested in approximately 5500 individuals aged 12 months to 81 years, as part of a Collaborative Research and Development Agreement (CRADA) between Aviron and the National Institute of Allergy and Infectious Disease (NIAID) of the National Institutes of Health (NIH). A pivotal Phase 3 clinical trial in children published in the May 14 New England Journal of Medicine demonstrated a 93 percent protection rate by FluMist(TM) against culture-confirmed influenza and a 98 percent reduction of influenza-associated otitis media (ear infections). In another study among healthy adults, subjects receiving FluMist(TM) experienced an 85 percent protection rate against laboratory-documented influenza. Those receiving injectable vaccine experienced a 71 percent protection rate. Aviron has an additional large, randomized, multi-center double-blind, placebo-controlled study underway to evaluate the benefits of FluMist(TM) in reducing work loss and health care utilization in adults. "We are particularly pleased that this study is being led by a group at Baylor College of Medicine with a long, established track record of research in influenza vaccines. This study also shows the commitment of Scott and White Hospital and Clinic and the Texas Department of Health investigators to understand the deployment of preventative technologies for their population," Dr. Read said. Aviron is a biopharmaceutical company based in Mountain View, CA focused on prevention of disease. The company's goal is to develop vaccines which offer cost-effective prevention of a wide range of infections that affect the general population. The majority of Aviron's products under development are live vaccines against viral infections. FluMist(TM) is currently under review by the U.S. Food and Drug Administration. Products in clinical development include parainfluenza (PIV-3) and, in collaboration with SmithKline Beecham Biologicals, a subunit vaccine against Epstein-Barr Virus (EBV) infection, a major cause of infectious mononucleosis. Products in pre-clinical development include vaccines for respiratory syncytial virus (RSV), cytomegalovirus (CMV) and genital herpes (HSV-2). This press release contains forward-looking statements. Actual results may differ materially from those suggested here. Additional information concerning factors that could cause such a difference is contained in Aviron's Annual Report on Form 10-K for the year ended December 31, 1997. To receive an index and copies of recent press releases, call Aviron's News-On-Call toll-free fax service, 800-758-5804, extension 114000. Additional information about the company can be located at aviron.com. SOURCE Aviron /CONTACT: media, Karen Gilbert of Aviron, 650-919-6578; or John Bluth or Louise Leavitt of Fleishman-Hillard, 212-453-2000, for Aviron; or investors, Lyn Christenson of Aviron, 650-919-3716/ /Company News On-Call: prnewswire.com or fax, 800-758-5804, ext. 114000/ /Web site: aviron.com (AVIR) Headlines Next Story AVIR %MTC V%PRN P%PRN