FDA grants Orphan Drug Status for to-BBB’s lead product
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to-BBB announced that the food and Drug Administration (FDA) has granted Orphan Drug Designation for to-BBB’s brain cancer lead product 2B3-101.
As a proprietary brain-targeted version of the marketed product Caelyx®/Doxil® (PEG-liposomal doxorubicin), 2B3-101 uses glutathione (GSH) to safely enhance the delivery of doxorubicin across the blood-brain barrier. The therapeutic benefit and predictable safety profile of 2B3-101 has been successfully demonstrated in pre-clinical studies and the product is ready to start clinical testing in a phase I/II study. 2B3-101 can be developed for multiple brain cancer indications and to-BBB considers development for brain metastases of breast cancer as well as glioma.