Jeanine L. Bussiere

TL;DR: Apo2L may have potent anticancer activity without significant toxicity toward normal tissues, and cooperated synergistically with the chemotherapeutic drugs 5-fluorouracil or CPT-11, causing substantial tumor regression or complete tumor ablation.

TL;DR: These findings not only provide a novel insight into the pathogenesis of the transplant-related atherosclerosis, but also point to a new therapeutic strategy that involves targeting of homing, differentiation and proliferation of putative smooth-muscle progenitor cells derived from the recipient.

TL;DR: Estimates of Apo2L/TRAIL kinetics in humans were provided, suggesting that on a milligram per kilogram basis, doses significantly lower than those used in xenograft studies could be effective in humans.

TL;DR: Adequate designs in NHP are presented for developmental toxicity (embryo-fetal development, pre-postnatal development, enhanced pre- postnatal development), reproductive toxicity (male and female), and juvenile toxicity studies.

TL;DR: Alternative approaches, including animal models of disease, genetically modified mice, or use of surrogate molecules, may improve the predictive value of preclinical safety assessments of species-specific biopharmaceuticals, although many caveats associated with these models must be considered.