May 6, 2013
Chimerix reported results from a phase II trial of CMX001 for the treatment of life-threatening infection with adenovirus (AdV). This open label, expanded access study enrolled 57 patients infected with AdV. Subjects received oral CMX001 twice weekly. The median duration of CMX001 treatment was 12 doses over seven weeks, with the longest duration of treatment of 43 weeks. Data demonstrated that 34/57 patients (79%) had at least a 90% decrease in the amount of virus in the blood at the end of treatment. Subjects who had a 90% decrease in AdV blood levels had overall better outcomes, with 9% AdV-associated deaths, compared to a 27% mortality rate for patients who had less than a 90% decrease in viral levels. Subjects who began CMX001 therapy as soon as virus was detected in the blood and before symptoms were present, had a lower mortality rate of less than 7%, while patients who were treated after virus was detected in the blood and symptoms had developed had a mortality rate of 37% during the one-month follow-up period. The drug was well tolerated. Based on these results, Chimerix initiated a phase II study of CMX001 as an early treatment for AdV infection in young adults and children who have received a stem cell or bone marrow transplant.
April 2, 2012
Biota Holdings issued results from a phase II trial of vapendavir for the treatment of naturally acquired human rhinovirus (HRV) infection in asthmatics. This multicenter, randomized, double-blind, placebo controlled study enrolled 300 subjects who received either 400 mg of vapendavir or placebo twice daily for six days. The trial was conducted over two consecutive rhinovirus seasons. The primary efficacy parameter was the mean daily difference in WURSS-21 (Wisconsin Upper Respiratory Symptom Survey-21) severity score over days two through four. Vapendavir treatment resulted in a statistically significant reduction in the severity score of cold symptoms when compared to placebo (p≡0.028). The WURSS scores also showed a statistically significant improvement in mean daily difference through day 14 (p≡0.001). Reduction in the use of asthma reliever medication showed a positive trend toward improvement in the vapendavir group as early as day three of treatment and reached statistical significance on day 13 (p≡0.045). In addition, subjects receiving vapendavir showed a statistically significant lower incidence of virus infection (74.4%) compared to placebo (91.4%) on day three (p≡0.025) and evening peak expiratory flow (PEF) was significantly higher in the vapendavir group on day five (p≡0.023). There were no serious adverse events and generally BTA798 was well tolerated.
November 11, 2002
Inspire Pharmaceuticals reported positive results from a phase II trial investigating INS37217 for the treatment of upper respiratory infection (common cold). The data showed INS37217 demonstrated a statistically significant improvement in post-nasal drip and malaise compared to placebo. The study, a multi-center, double blind, placebo-controlled trial, consisted of 101 subjects receiving the drug for six days. Symptoms were recorded for two weeks following dosing. Consistent trends were demonstrated with other symptoms as compared to placebo, including improvements in rhinorrhea (runny nose), nasal congestion, cough, facial pain and pressure and sleep disturbance. INS37217 was well tolerated in subjects, with no serious adverse events reported.
March 25, 2002
The Antiviral Drugs Advisory Committee of the FDA has voted not to recommend approval of Picovir (pleconaril) for the treatment of the common cold in adults. While acknowledging efficacy, the committee requested that additional data not included in the pivotal trials be provided. Picovir is being co-developed and co-promoted by ViroPharma and Aventis Pharmaceuticals.