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Cell>Point and FDA agree on SPA for Phase III lung cancer trial

Submitted by Ross Bonander Fri 03/16/2012
lung-left.jpg

Cell>Point announced today that it has received a letter from the US Food & Drug Administration saying that they have agreed with the company's proposed Special Protocol Assessment (SPA) for Cell>Point's Phase III pivotal clinical study of technetium-99m-EC-G in lung cancer.

According to the SPA, this Phase III trial will assess the use of Cell>Point's molecular imaging product candidate, technetium-99m-EC-G (EthylenediCysteine-n-acetyl-Glucosamine) in the diagnosis and staging of lung cancer.

In the study, patients will receive technetium-99m-EC-G intravenously, and an image will be captured by a Single Photon Emission Computed Tomography (SPECT) camera (aka a gamma camera).

Source: Therapeutics Daily


 
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