ON December 19, 2017 Tanvex rported that its recently completed pharmacokinetics (PK) study of the company’s biosimilar product candidate, TX16, showed favorable results supporting PK similarity of TX16 and the reference product, US-licensed Avastin (Press release, Tanvex BioPharma, DEC 19, 2017, View Source [SID1234524595]). In a prospective, single dose, double blinded, parallel group study conducted in 69 healthy adult male subjects, the test to reference ratio of geometric least squares (LS) mean and corresponding 90% confidence interval (CI) for the primary endpoint, AUC 0-∝, were within the acceptance range of 80.00 to 125.00%. In addition the test to reference ratios of geometric LS means and corresponding 90% CIs of the other PK endpoints, AUC 0-t and C max, were also within the acceptance range of 80.00% to 125.00% demonstrating similar peak concentrations and extent of exposure between TX16 and Avastin.
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Overall, both TX16 and Avastin were generally safe and well tolerated by the study subjects, with mild to moderate treatment-emergent adverse events and no severe or serious adverse events reported.
Avastin (bevacizumab) is a vascular endothelial growth factor-specific angiogenesis inhibitor approved in the US for the treatment of multiple indications in combination with other agents, including metastatic colorectal cancer, non-squamous non-small cell lung cancer, glioblastoma, metastatic renal cell carcinoma, cervical cancer, and recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
According to IMS data, US sales of Avastin were US$3.1 billion in 2016.