Gedeptin Granted Orphan Drug Status for Oral and Pharyngeal Cancers

PNP Therapeutics announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation to Gedeptin (adenoviral vector expressing E. coli purine nucleoside phosphorylase gene) for the intratumoral treatment of anatomically accessible oral and pharyngeal cancers, including cancers of the lip, tongue, gum, floor of mouth, salivary gland, and other oral cavities.

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The company has completed a Phase 1 clinical trial designed to evaluate the safety and efficacy of Gedeptin in the treatment of head and neck cancer. There were significant tumor responses in patients treated with the highest doses of Gedeptin.

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