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| |  PAS MEETING: Pleconaril Effective For Viral Meningitis, Polio Treatment SAN FRANCISCO, CA -- May 6, 1999 -- Two presentations at the Pediatric Academic Societies' annual meeting show that Viropharma Inc.’s pleconaril is effective in the treatment of patients with viral meningitis and a patient with polio. Pleconaril is a first of a kind, orally-active antiviral agent for the treatment of diseases caused by picornaviruses including viral meningitis, viral respiratory infection (VRI) and life-threatening diseases such as chronic meningoencephalitis, neonatal enteroviral disease, polio and myocarditis. Mark Sawyer, MD, associate professor of pediatrics, University of California School of Medicine, San Diego, presented data from a double-blind, placebo-controlled study of pleconaril in children ages four to 14 years (mean age eight) who were administered either pleconaril or placebo three times daily. Pleconaril-treated patients experienced consistent and durable responses as measured by the time to absence of headache, the time to absence of all symptoms and time to a global assessment score (GAS) of zero. Clinical responses were noted as early as 24 hours after initiation of pleconaril treatment. At the conclusion of treatment (day eight), the percentage of pleconaril-treated patients with headache, disease symptoms or GAS score greater than zero was reduced by 50 percent, 38 percent and 46 percent respectively when compared with placebo-treated patients. The median time to GAS of zero in pleconaril-treated patients was reduced by three days (six versus nine days) compared to placebo-treated patients. In an analysis of patients eight years of age and older, the time to elimination of all symptoms was reduced by three days in pleconaril-treated patients compared to placebo-treated patients and headache duration was reduced by one day. By day four of treatment, virus shedding from the throat was reduced 80 percent in pleconaril-treated compared to placebo-treated patients evaluated for virus culture. There were no overall differences in adverse event profiles between pleconaril- and placebo-treated patients. "Pleconaril may become the first treatment for children suffering from viral meningitis," Dr. Sawyer said. "I'm especially pleased that there have been no safety concerns with this drug." Jose Romero, MD, associate professor of pediatrics, pathology and microbiology, University of Nebraska Medical Center and Creighton University, presented data on a four-month-old child that developed vaccine-associated poliomyelitis (polio) infection of the central nervous system after receiving an oral polio vaccination. Pleconaril was administered to the patient for 16 days. After day 10 of pleconaril treatment, the poliovirus was completely eliminated from the patient's cerebral spinal fluid (CSF). "Poliomyelitis, secondary to wild type or vaccine strain, continues to be a world-wide threat," Dr. Romero said. "The fact that we've seen such a positive response in this patient, as well as other polio patients, is further evidence of the benefit of pleconaril for the treatment of poliovirus infections." Picornaviruses are a large, prevalent group of viruses that are responsible for the majority of all human viral illnesses and are the leading infectious agent of the central nervous system. The spectrum of picornavirus disease ranges from severe illnesses to common maladies and includes viral meningitis, myocarditis, polio, viral respiratory infection and the common cold. The severity and symptoms of the disease depend on three factors: the strain of infecting virus, the infected individual's health status and the organ or tissue affected. Picornavirus infections can progress, particularly in immune compromised individuals, to serious degenerative and life-threatening diseases. There are currently no antiviral treatments for picornavirus diseases. Viral meningitis, caused by picornaviruses, is characterised by a severe headache, stiff neck, fever, muscle pain, nausea, vomiting and malaise. Patients with viral meningitis often require emergency care and hospitalisation. In about 25 percent of viral meningitis patients, the illness continues for more than two weeks. The cost of care for a patient with viral meningitis often exceeds $5,000 US. Poliovirus, the picornavirus that causes poliomyelitis, is the target of a global eradication campaign launched in 1988 by the World Health Organization. The strategy for polio eradication relies principally on widespread vaccination. The last reported case of wild polio in the U.S. was in 1979 and the last case in the Americas was in 1991. However, paralytic polio remains endemic in other parts of the world, particularly in Central Asia and Africa. Continued immunisation is recommended in polio-free countries to reduce the risk of importation of wild poliovirus from remaining polio-endemic areas. Use of oral polio vaccine (OPV) can, however, in rare cases cause vaccine-associated paralytic poliomyelitis. No therapy has been proven to be effective for the treatment of wild or vaccine-associated polio.
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