SAMSON-I is a double-blind, randomized, 3-arm, parallel group study to demonstrate the equivalent pharmacokinetic properties of a single intravenous dose of HD204, US-licensed Avastin and EU-licensed Avastin. A total of 119 healthy male volunteers aged 18-50 years old received a single infusion IV dose of 1mg/kg of study drug and monitored for 71 days.
The primary objective was to establish pairwise PK similarity between all 3 drugs by evaluating the area under the concentration curve from time zero to infinity (AUC0-inf) as its primary endpoint. The 90% CI of the ratio of geometric means of log-transformed AUC0-inf is used to assess bioequivalence between the test and reference using the bioequivalence interval of 80.00% to 125.00%. Bioequivalence is declared if the 90% CI for the ratio falls within 80.00% and 125.00% for the primary PK parameter AUC0-inf for the comparisons: HD204 versus EU-Avastin, HD204 versus US-Avastin. The analysis is repeated for secondary parameters Cmax and AUC0-last as well.
Results have indicated that the 90% CIs for the ratio of the geometric means of HD204 to US-Avastin, HD204 to EU-Avastin, and EU-Avastin to US-Avastin were all within the acceptance interval of 80.00% to 125.00% for AUC0-inf, AUC0-last, and Cmax thus demonstrating equivalency PK properties for all three treatments.
There are no notable differences between all 3 drug products in terms of vital signs, electrocardiograms (ECGs) or laboratory tests. No safety signals were observed in this study and no positive anti-drug antibodies were observed in the HD204 group.
Overall, the study demonstrated that HD204 is bioequivalent to both US-licensed Avastin and EU-licensed Avastin after a single IV infusion at 1mg/kg.
Dr. Lisa Park, CEO of Prestige BioPharma, commented that "our top-line Phase I results for HD204 reflect Prestige's commitment to providing millions of patients with greater access to high-quality, safe, affordable treatment. We also look forward to further progress in the Phase III global clinical study of HD204."
Currently, Prestige BioPharma is performing a global Phase III study, SAMSON-II in patients with metastatic or re-current non-squamous non-small cell lung cancer. Prestige plans for filing with European Medicines Agency (EMA) and US Food and Drug Administration (FDA) in 2020.
These top-line positive results data will be presented at an upcoming scientific conference, ESMO 2019 being held September 31 - October 1, 2019 in Barcelona, Spain.
For additional information, please visit http://www.prestigebiopharma.com/news-resources/.
About Prestige BioPharma
Prestige BioPharma is a Singapore-based biopharmaceutical company focusing on the development of biosimilars and new antibody therapeutics. Its lead program, HD201 trastuzumab biosimilar, has been filed with EMA in April 2019 and will also be filed with USFDA in 2019. Prestige BioPharma's next products in line include a Bevacizumab biosimilar (HD204) in Phase III, an Adalimumab biosimilar (PBP1502) in Phase I and an innovative anti-PAUF mAb (PBP1510) for the treatment of pancreatic cancer in preclinical stages. Manufacturing facilities for global commercial supply are located in Osong, South Korea. For more, please visit www.prestigebiopharma.com, or click on Facebook, LinkedIn.
Prestige BioPharmaGlobal Communication Team
Ms. Felicia Ang
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