Publications by authors named "Vivek G Nayak"
Purpose: This phase III study compared the efficacy and safety of proposed biosimilar MYL-1402O with reference bevacizumab (BEV), as first-line treatment for patients with stage IV non-squamous non-small-cell lung cancer.
Patients And Methods: Patients were randomly assigned (1:1) to receive MYL-1402O or bevacizumab with carboplatin-paclitaxel up to 18 weeks (6 cycles), followed by up to 24 weeks (8 cycles) of bevacizumab monotherapy. The primary objective was comparison of overall response rate (ORR), based on independently reviewed best tumor responses as assessed during the first 18 weeks.
Recombinant biopharmaceuticals can induce generation of anti-drug antibodies, which could potentially neutralize therapeutic drug activity. In this report, we describe development and validation of a cell-based assay for detection of neutralizing antibodies (Nab) against insulin and insulin analogues. In order to achieve clinically meaningful sensitivity the method used an early signalling event, insulin induced insulin receptor phosphorylation as the endpoint.
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- Tregopil is a new PEGylated human insulin being developed for oral delivery in diabetes treatment, focused on creating a specific method to measure its levels in patients taking Glargine.
- A sensitive electrochemiluminescent ELISA method was successfully created, capable of quantifying Tregopil in serum with a low limit of detection.
- This method demonstrates minimal cross-reactivity with Glargine, making it a reliable tool for accurately measuring Tregopil in Type 1 diabetes patients during clinical studies.