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Terra Biological Pivots To Pre-IND Trials After FDA Spoils Medical Food Labeling

 
• By Malcolm Spicer

FDA warning letter "was a complete surprise to us, especially as we had been advising FDA of our marketing of the CRONaxal product, in writing, for approximately three years as part of our 'orphan drug designation' for glial tumors requirement," says Terra Biological CEO Alan Cook. The firm received an orphan drug designation for oxaloacetate as a treatment for gliomas in 2012.

Terra Biological LLC had an orphan drug designation for oxaloacetate and a pre-investigational new drug meeting with FDA before it received a warning letter because it didn't have the agency's approval for the ingredient as a medical food.

The San Diego firm also had exhibitions at anti-aging and regenerative medicine conferences promoting its oxaloacetate-containing CRONaxal product for treatment of gliomas, a type of tumor that starts in the glial cells of the brain or the spine, and recognition as a potential investment candidate because of oxaloacetate's orphan drug designation before the Office of Compliance in FDA's Center for Food Safety and Applied Nutrition in July 2017 sent a

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