Acute Radiation Syndrome
SNBL USA is in a unique position to perform ARS studies, from demonstration of efficacy in representative animal models, to pivotal nonclinical studies under the FDA’s Animal Efficacy Rule.
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As a drug class, Nucleic Acid-based Therapeutics represents a diverse spectrum of chemistry, constructs, and delivery options.
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Pre-SOT Abstract: Blood urea nitrogen (BUN) and creatinine (CRN) have been used as biomarkers (BMs) for detecting drug-induced renal toxicities. Since FDA and EMA proposed several BMs in rats, such as urinary protein, albumin (ALB), β2-microglobulin (B2M), clusterin (CLU) and cystatin C (CysC), we examined the availability of these urinary BMs in cynomolgus monkeys. We used 3 renal toxic compounds: gentamicin (GM), cisplatin (CDDP) and puromycin aminonucleoside (PAN). Three cynomolgus monkeys/group (total 9 animals) received GM (sc, 40 mg/kg/day, 7 days), CDDP (iv, 3 mg/kg, single dose) or...Read More
Comparison of Histopathology Findings in Macaque (Rhesus Vs Cynomolgus) Tissues and Organs Following a Single Dose Of Irradiation R.Love1, K.Jackson1, R. Manning1, S.Glaza1, T.Beck1, K. Fukuzaki1, and R. Nagata2. 1SNBL USA, Ltd., Everett, WA, USA; 2Shin Nippon Biomedical Laboratories, Ltd., Kagoshima, Japan In continuing efforts to develop and characterize well defined animal models for the acute radiation syndrome under the FDA Animal Rule (21CR314, subpart 1), total body irradiation (TBI) was applied to six cynomolgus macaques (5 to 9 kg) at a total dose of 7.55 Gray (Gy) and to eight...Read More
Everett, WA – March 5, 2015 – SNBL USA, the experts in preclinical research, announced today the members of its newly-formed ARS Advisory Board, comprised of leading experts in the field of radiation biology and research. The Advisory Board will serve to provide strategic vision and scientific guidance to SNBL USA’s ARS program. “We are excited and honored to announce the formation of this Board as we broaden our ARS program,” said Dr. Koichiro Fukuzaki, SNBL USA President and CEO. “These distinguished members represent years of technical and scientific expertise, providing...Read More