Key result
A newly developed oral heparin derivative administered for 14 days at doses up to 640 mg/kg did not cause any significant toxic effects on body weight, hematological, or serum biochemical parameters in male cynomolgus monkeys.
Why the study?
Does a newly developed oral heparin derivative cause toxicity in male cynomolgus monkeys over 14 days?
Does a newly developed oral heparin derivative cause toxicity in male cynomolgus monkeys over 14 days?
p-value: p=>0.05
A newly developed oral heparin derivative showed no toxic effects in a 14-day cynomolgus monkey model, supporting its further non-clinical development.
Supports further nonclinical development of oral heparin derivative; leaves open translation to human safety studies.
Toxicity screening of a newly developed oral heparin derivative was carried out in twelve male cynomolgus monkeys (Macaca fascicularis), composed of three treatment and vehicle control groups. A newly orally active heparin derivative, developed by Seoul National University, was given to the treatment group at three doses with low (12.8 mg/kg), medium (89.6 mg/kg) and high (640 mg/kg) doses for 14 days. A treatment group did not show any change in body weights, hematological parameters (e.g., RBC, WBC, platelet, PDW, MPV, etc.) and serum biochemical parameters (e.g., AST, ALT, BUN, etc.) for 2 weeks compared with those of the vehicle control group. These findings indicated that the oral anticoagulant drug, a newly developed oral heparin derivative, did not have any toxic effect for 2 week in this study. The present study will be valuable in the proper interpretation for non-clinical study using cynomolgus monkeys in the development of a new drug of heparin derivative.
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Kim et al. (2007) studied Healthy (Toxicity screening) (n=12). Oral heparin derivative (LMWH-DOCA conjugate) vs. Vehicle control was evaluated on Toxicity (body weight, hematological, and serum biochemical parameters) (p=>0.05). A newly developed oral heparin derivative administered for 14 days at doses up to 640 mg/kg did not cause any significant toxic effects on body weight, hematological, or serum biochemical parameters in male cynomolgus monkeys.
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