Advancing novel molecular imaging agents from preclinical studies to first-in-humans phase I clinical trials in academia--a roadmap for overcoming perceived barriers.
Bioconjug Chem
; 26(4): 625-32, 2015 Apr 15.
Article
in En
| MEDLINE
| ID: mdl-25781873
ABSTRACT
There is a critical need to advance promising novel molecular imaging (MI) agents for cancer from preclinical studies to first-in-humans Phase I clinical trials in order to realize their full potential for cancer detection and for predicting or monitoring response to targeted ("personalized") cancer therapies. Steps to clinical translation include radiopharmaceutical formulation, preclinical pharmacology and toxicology studies, clinical trial design and human ethics approval, and regulatory agency submission. In this Topical Review, we provide a "roadmap" to advancing one class of novel MI agents to Phase I trials in academia and illustrate the processes that we have successfully applied for (111)In-labeled pertuzumab, a MI probe for monitoring response of HER2-positive breast cancer to treatment with trastuzumab (Herceptin). We hope that our experience will encourage other academic radiopharmaceutical scientists to embrace this challenge.
Full text:
1
Database:
MEDLINE
Main subject:
Breast Neoplasms
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Radiopharmaceuticals
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Antibodies, Monoclonal, Humanized
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Trastuzumab
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Indium
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Antineoplastic Agents
Language:
En
Journal:
Bioconjug Chem
Year:
2015
Type:
Article