Publications by authors named "Julie Donovan"
Background: Surotomycin, a novel, orally administered, cyclic, lipopeptide antibacterial in development for the treatment of Clostridium difficile-associated diarrhea, has demonstrated minimal intestinal absorption in animal models.
Methods: Safety, tolerability, and plasma pharmacokinetics of single and multiple ascending oral doses (SAD/MAD) of surotomycin in healthy volunteers were characterized in two randomized, double-blind, placebo-controlled, phase 1 studies.
Results: Participants were sequentially enrolled into one of four SAD (500, 1000, 2000, 4000 mg surotomycin) or three MAD (250, 500, 1000 mg surotomycin twice/day for 14 days) cohorts.
A pharmacokinetic analysis was performed for single intravenous doses of daptomycin 8 or 10 mg/kg in subjects aged 2 to 6 years. Proportional increases in maximum plasma concentration (68.4 μg/mL, 79.
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- Researchers conducted a clinical trial using a recombinant vaccinia virus (rV-B7.1) to treat metastatic melanoma by intralesional vaccination, addressing the challenges of local T cell tolerance in the melanoma microenvironment.
- The trial involved 12 patients and reported minimal side effects like low-grade fever and fatigue, leading to partial response in 1 patient and disease stabilization in 2 others, with one surviving without disease for over 59 months post-vaccination.
- The findings showed increased antibody and T cell responses post-vaccination, suggesting that rV-B7.1 may effectively alter the local tumor environment and improve immune responses against melanoma.