The following data were reported at the 53rd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Denver.
• Chimerix Inc., of Durham, N.C., disclosed results from its exploratory Phase II Study 202 evaluating brincidofovir (CMX001) in hematopoietic cell transplant (HCT) recipients with early adenovirus (AdV) infection. Study 202 was the first trial of an antiviral agent in AdV infection. CMX001 is an oral nucleotide analog lipid-conjugate that has demonstrated activity against all pathogenic families of double-stranded DNA (dsDNA) viruses, including herpesviruses, adenoviruses and polyomaviruses. Safety and tolerability data from the 48-subject trial confirmed the lack of hematologic and renal toxicity for once-weekly or twice-weekly CMX001 dosed for six to 12 weeks, and showed the successful implementation of the safety monitoring and management plan to address gastrointestinal (GI) side effects reported in earlier trials. Temporary dose interruptions for grade 3 diarrhea were successfully utilized in the trial, with one permanent discontinuation for diarrhea in the CMX001 QW cohort. Three additional discontinuations in the trial were reported for abdominal pain (CMX001 twice-weekly cohort), lower GI hemorrhage (CMX001 twice-weekly cohort) and severe rash (placebo cohort).
• Durata Therapeutics Inc., of Chicago, presented results from its two Phase II DISCOVER (Dalbavancin for Infections of the Skin Compared to Vancomycin at an Early Response) studies and new in vitro data of dalbavancin, further characterizing the effect of the investigational treatment against Gram-positive bacteria. In the two randomized, double-blind studies, dalbavancin was shown to be non-inferior to the comparator regimen, vancomycin with an option to switch to oral linezolid, in treating acute bacterial skin and skin structure infections. In both studies, dalbavancin met its primary and secondary endpoints. Recipients in the dalbavancin arms of the studies had fewer treatment emergent adverse events than those in the comparator arms. The in vitro data showed activity against Staphylococcus aureus strains, including methicillin-resistant strains, recovered from patients with osteomyelitis-related wounds.
• Nanobio Corp., of Ann Arbor, Mich., said it will present preclinical data showing the safety and efficacy of a nanoemulsion adjuvanted intramuscular vaccine for the prevention of respiratory syncytial virus (RSV). RSV strikes nearly all children by the age of 3 and can be life-threatening for premature babies, children with other health conditions and the elderly. No vaccine for the prevention of RSV is commercially available.
• Novavax Inc., of Rockville, Md., presented results from clinical and preclinical studies of respiratory syncytial virus F-protein nanoparticle vaccine. In a Phase I study in 220 healthy elderly adults, the vaccine was compatible with co-administration of influenza vaccine. It was also well tolerated, and yielded increases in antibodies with the potential to be protective. A preclinical study evaluated passive protection by palivizumab-competing antibodies induced by RSV F vaccine.
• Theraclone Sciences Inc., of Seattle, presented results of a Phase I trial of TCN-202, a recombinant fully human monoclonal antibody for human cytomegalovirus, at the 53rd Interscience Conference on Antimicrobial Agents and Chemotherapy in Denver. The antibody was well tolerated, with no dose-limiting toxicities or serious adverse events, and had a favorable immunogenicity profile. The study enrolled 48 healthy volunteers at six dose levels. The subjects were followed for up to 60 days after drug infusion.