by John R. Fischer
, Senior Reporter | November 09, 2018
Columbia University’s Kreitchman PET Center is lending its resources and expertise to radiopharmaceutical provider Zionexa as part of a new partnership overseeing the development and commercialization of its PET diagnostic drug, EstroTep, in the U.S.
Currently only cleared for use in France, the targeted diagnostic biomarker indicates the presence of advanced stage and metastatic breast cancer based on estrogen receptor status in patients.
“Image-based biomarker quantitation provides a noninvasive way to personalize cancer therapy,” Akiva Mintz, director of the Columbia University PET Center, said in a statement. “The ability to visualize estrogen receptor expression in all diseased tissue has the potential to change patient management, as cancer is a very heterogeneous disease that is not always accurately evaluated by biopsying a single site of disease, as is the current standard of practice.”
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More than 250,000 new cases of breast cancer were reported in 2017 throughout the U.S., making it the most common cancer to affect women.
Zionexa is currently in the process of obtaining clearance for the biomarker, which was on display
back in June at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting in Philadelphia.
With the PET Center, Zionexa will engage in chemistry and method validation research to support the use of its product. “We both have a mission to deliver products that help doctors make better clinical decisions. The work we are doing here with the team at Columbia is helping us to prepare to submit our product to the FDA for evaluation, and hopefully a future commercial launch in the USA” Peter Webner, CEO of Zionexa US, said in a statement.
The partnership is a first for Zionexa, which launched
earlier this year under Denos Health Management, the former primary stakeholder of PET diagnostics manufacturer Cyclopharma France and U.S. The company is the former U.S. division of Cyclopharma and was established following the sale of Cyclopharma to Curium.
As part of the acquisition agreement, Denos Health Management purchased the rights to the pipeline of Cyclopharma France, including EstroTep, the first of a number of products to be submitted to the FDA by Zionexa.