To: T-Lo Greens who wrote (78 ) 7/14/1999 2:14:00 PM From: scaram(o)uche Read Replies (1) | Respond to of 2557
Again, your words only point to your ignorance. One phase III has been completed and results reported. Read first, open mouth later. NDA could be filed this Fall. ViroPharma Announces Positive Adult Meningitis Study Results EXTON, Pa., Jan. 6 /PRNewswire/ -- ViroPharma Incorporated (Nasdaq: VPHM - news) announced today the results from its preliminary evaluation of the second of four studies of pleconaril (two in adults and two in children) for the treatment of viral meningitis. The trial was a double-blind, placebo- controlled study of 130 adult patients with viral meningitis who were administered either a 200 mg dose of pleconaril or a placebo three times per day. Patients treated with 200 mg of pleconaril experienced both a statistically significant and clinically beneficial reduction in duration of headache, the most significant disease symptom and the Company's primary endpoint in this study. Pleconaril-treated patients experienced a clinical benefit within 24 hours after initiation of therapy. The median duration of headache for pleconaril-treated patients was reduced by 2 days in patients with confirmed enteroviral meningitis (p = 0.04) and by 1 day in all randomized patients (p = 0.03). The median duration of headache was 9 days in the placebo-treated patients. 75% of pleconaril-treated patients, both with confirmed enteroviral meningitis and all randomized, achieved the primary endpoint 4 days and 3 days sooner, respectively, than the placebo-treated patients. ''These positive data provide further evidence of the benefits of pleconaril to patients suffering from viral meningitis,'' said Claude Nash, President and Chief Executive Officer. ''We will use the results of our first two viral meningitis studies, together with our two ongoing trials, in our New Drug Application for pleconaril.'' ''Patients with enteroviral meningitis currently have no antiviral treatment alternatives,'' said Harley Rotbart, MD, a leading authority on picornavirus disease. ''I am enthusiastic about the benefits that pleconaril will provide to patients with this disease and with other diseases caused by picornaviruses.'' Fewer patients treated with 200 mg of pleconaril reported adverse events than placebo-treated patients. The nature of the majority of the adverse events reported in the study were similar to symptoms of the disease. In addition to the patients described above, 68 patients received a 400 mg dose of pleconaril three times per day. In this higher dose group, there was a slight increase in adverse events when compared to placebo. Data from the higher dose group will be used in pleconaril's safety analysis. The Company is continuing its analysis of the data from this study and plans to have a complete report of the results presented at the annual meeting of the American College of Physicians in April 1999. Picornaviruses are a large, prevalent group of viruses that are responsible for the majority of all human viral illnesses. The spectrum of picornavirus disease ranges from severe illnesses to common maladies and includes viral meningitis, myocarditis, neonatal enteroviral disease, 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 picornaviral diseases. Viral meningitis is characterized by a severe headache, stiff neck, fever, muscle pain, nausea, vomiting and malaise. Patients with viral meningitis often require emergency care and hospitalization. In about 25% of viral meningitis patients, the illness continues for over 2 weeks. Pleconaril is a novel, orally bioavailable small molecule with broad anti-picornavirus activity. ViroPharma Incorporated is committed to the commercialization, development and discovery of antiviral pharmaceuticals. The Company is focused on drug development and discovery activities in viral diseases including viral meningitis, viral respiratory infection, the common cold, RSV pneumonia and hepatitis C. This press release contains forward-looking statements, including statements relating to ViroPharma's plans for future clinical trials and for filing a New Drug Application with the Food and Drug Administration (FDA). These forward-looking statements are based on management's current expectations. There can be no assurance that planned or ongoing clinical trials can be successfully concluded. The conduct of clinical trials and acquiring regulatory approval for investigational pharmaceutical products are subject to risks and uncertainties. There can be no assurance that FDA or other regulatory authority approval for pleconaril or any other product candidate under development by ViroPharma will be granted on a timely basis or at all. Neither the FDA nor any other regulatory authority has approved pleconaril or any of ViroPharma's other product candidates for commercialization. These factors, and other factors that could cause future results to differ materially from management's current expectations, include, but are not limited to, those described in Exhibit 99 attached to ViroPharma's Annual Report on Form 10-K for the year ended December 31, 1997 filed with the Securities and Exchange Commission. The forward-looking statements contained in this press release may become outdated over time. ViroPharma does not assume any responsibility for updating any forward-looking statements. SOURCE: ViroPharma Incorporated