Page 69 - ITPS-8-2

INNOSC Theranostics and
Pharmacological Sciences Preclinical study of GBpoietin biosimilar

the repeated-dose toxicity study, as shown in Figure 4F. 4. Discussion
However, the differences in BUN levels among the groups
were not significant (P = 0.02). This study presents the overall results of the preclinical safety
evaluation of GBpoietin in rats through a comparative
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3.5. Necropsy findings acute toxicity study with Eprex , following subcutaneous
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Single representative subjects from all Treatment, Placebo, administration. The findings demonstrated that the
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and Control groups were euthanized for necropsy findings. toxicological profiles of GBpoietin and Eprex were similar
External surfaces, all orifices, cranial cavities, external and aligned with the known pharmacology of EPO alfa,
surfaces of the brain and spinal cord, thoracic, abdominal, previously studied for a comprehensive safety and toxicity
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and pelvic cavities, cervical tissues, and organs were observed assessment of rhEPO. No side effects or signs of toxicity
for any abnormalities. However, no abnormal lesions were were observed during daily observations of the animals
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found during necropsy examination, as shown a Figure 5. inoculated with GBpoietin or Eprex in the comparative
acute toxicity assay. There were no changes in fur or
3.6. Histopathology study pigmentation, and the eyes and mucosal surfaces appeared
No morphological signs of toxicity were observed in normal, as did the somatomotor activity and behavior.
internal organs such as the kidney, liver, lung, and spleen Proper responses to stimulation were obtained, and no
of experimental animals from the single- and repeated- deaths were reported during the study. Upon evaluation
dose toxicity studies (Figure 6). No lesions of pathological of the inoculation site, no signs of damage attributable to
significance like degeneration or cellular necrosis were the administration of rhEPO. 24-26 were evidenced. The only
found on these internal organs in all treatment groups, abnormalities detected were hemorrhagic areas observed in
including the group that received Eprex . the repeated-dose toxicity study, but these were attributed
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A

B G

C H

D I

E J

F

Figure 5. Representative necropsy findings of both single- and repeated-dose toxicity studies. (A) Control, (B) Placebo, (C) Treatment 1, (D) Treatment
2, (E) Treatment 3, and (F) Treatment 4 groups of single-dose toxicity study. (G) Control, (H) Placebo, (I) Treatment 1, and (J) Treatment 2 groups of
repeated dose toxicity study.

Volume 8 Issue 2 (2025) 63 doi: 10.36922/itps.5797