The toxicological effect of 4-week repeated intravenous injection of activin a/BMP-2 chimera and 2-week recovery study in Beagle dog*

Han, Shi Huan; Zheng, Guang Bin; Lee, Jae Hyup

doi:10.1080/01480545.2019.1572181

Cited by 2 publications

(3 citation statements)

References 32 publications

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“…However, these changes were not considered toxicologically significant in this study because values for WBC and NEUT still remained within the normal range of (6–17) × 10 9 per liter for the WBC count and (3–12) × 10 9 per liter for the NEUT count in a dog. Similar with the results of the hematological examination, the level change of MONO (%), LYMPH, EO, TG, and Na + obtained in the blood biochemical examination could also be considered as no-toxicological significance as values were also within the limit of historical control data as reported [ 16 , 17 ]. Although a statistical difference in CHOL levels was observed between the 15 and 30 mg/kg groups compared to the negative control group, it appears that the increase approaching the clinical range was attributable to the rise in HDL, or ‘good’ cholesterol.…”

Section: Discussionsupporting

confidence: 74%

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Toxicity and Toxicokinetics of a Four-Week Repeated Gavage of Levamisole in Male Beagle Dogs: A Good Laboratory Practice Study

Zhang,

Wang,

Chen

et al. 2024

Pharmaceuticals

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Levamisole (LVM) is considered an immunomodulatory agent that has the potential to treat various cancer and inflammation diseases. However, there is still much debate surrounding the toxicokinetic and toxicological information of LVM. Therefore, it is crucial to assess its toxicity to provide useful data for future human LVM risk assessments. In this study, a barrier environment was established under the guidance of good laboratory practice (GLP) at the Fujian Center for New Drug Safety Evaluation. Male beagle dogs were orally administered with 5, 15, and 30 mg/kg of LVM daily for four weeks. Toxicity assessment was based on various factors such as mortality, clinical signs, food and water consumption, body weight, body temperature, electrocardiogram, ophthalmological examination, hematology, serum biochemistry, organ/body coefficients, histopathological study, and toxicokinetic analysis. The results of this study showed that LVM did not exhibit any significant toxicological effects on beagle dogs at the exposure levels tested. A no observed adverse effect level (NOAEL) of LVM was set at 30 mg/kg/day for male beagle dogs, which is equivalent to a 12-fold clinical dose in humans. Moreover, the repeated exposure to LVM for four weeks did not lead to any bioaccumulation. These findings provide valuable insights for future human LVM risk assessments.

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Section: Discussionsupporting

confidence: 74%

“…Levamisole (S-6-Phenyl-2,3,5,6-tetrahydroimidazo [2,1-b] [ 17 ] thiazole, CAS no. 240-654-6), with a purity of 98% was purchased from Sigma-Aldrich (St. Louis, MO, USA).…”

Section: Methodsmentioning

confidence: 99%

Toxicity and Toxicokinetics of a Four-Week Repeated Gavage of Levamisole in Male Beagle Dogs: A Good Laboratory Practice Study

Zhang,

Wang,

Chen

et al. 2024

Pharmaceuticals

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“…AB204 has been used successfully for spinal fusion in dog 11 and lacked adverse effects in toxicology studies, enabling human studies. 12 BV-265 for bone regeneration BV-265 is another recently-described DA BMP chimera that was created by combining activin A, BMP2, and BMP6 sequences (Fig. 1 and Table I) 13 .…”

mentioning

confidence: 99%

Design-augmented (DA) biologics: BMP chimeras for bone and cartilage regeneration

Gray

Choe

2020

Osteoarthritis and Cartilage

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Design-augmented (DA) biologics: BMP chimeras for bone and cartilage regeneration A recent review by Deng et al. 1 in this journal provided an excellent overview of bone morphogenetic proteins (BMPs) and their roles in healing bone and cartilage. BMPs have been used clinically in orthopedic procedures but they are typically administered at high, supra-physiological concentrations that have been linked to undesirable local and systemic side effects. BMPs engineered to have enhanced therapeutic potency may circumvent this problem and provide the desired effects of healing bone and cartilage while minimizing the likelihood of adverse events. Here we provide a brief discussion of such synthetic DA BMPs and their medical potential for bone and cartilage regeneration. Commonality of TGF-b superfamily members allows creation of DA BMPs* Predicted based on sequence similarity with AB204." y Predicted to have a similar effect as BMP7 based on inclusion of BMP6 sequence.

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The toxicological effect of 4-week repeated intravenous injection of activin a/BMP-2 chimera and 2-week recovery study in Beagle dog*

Cited by 2 publications

References 32 publications

Toxicity and Toxicokinetics of a Four-Week Repeated Gavage of Levamisole in Male Beagle Dogs: A Good Laboratory Practice Study

Toxicity and Toxicokinetics of a Four-Week Repeated Gavage of Levamisole in Male Beagle Dogs: A Good Laboratory Practice Study

Design-augmented (DA) biologics: BMP chimeras for bone and cartilage regeneration

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