Animal Safety, Toxicology, and Pharmacokinetic Studies According to the ICH S9 Guideline for a Novel Fusion Protein tTF-NGR Targeting Procoagulatory Activity into Tumor Vasculature: Are Results Predictive for Humans?

Animal Safety, Toxicology, and Pharmacokinetic Studies According to the ICH S9 Guideline for a Novel Fusion Protein tTF-NGR Targeting Procoagulatory Activity into Tumor Vasculature: Are Results Predictive for Humans?

Background: CD-13 targeted tissue factor tTF-NGR is a fusion protein selectively inducing occlusion of tumor vasculature with resulting tumor infarction. Mechanistic and pharmacodynamic studies have shown broad anti-tumor therapeutic effects in xenograft models. Methods: After successful Good Manufa...

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Bibliographic Details
Main Authors: Wolfgang E. Berdel, Saliha Harrach, Caroline Brand, Kathrin Brömmel, Andrew F. Berdel, Heike Hintelmann, Christoph Schliemann, Christian Schwöppe
Format: Article
Language:English
Published: MDPI AG 2020-11-01
Series:Cancers
Subjects:
non-clinical safety and toxicology studies
vascular targeting
fusion protein tTF-NGR
regulatory requirements for translation of anti-cancer drugs into human trials
seamless phase 0 micro-dosing and phase I trial concept
Online Access:https://www.mdpi.com/2072-6694/12/12/3536

Internet

https://www.mdpi.com/2072-6694/12/12/3536

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