PNP Therapeutics Inc. announced today the Food and Drug Administration has granted orphan drug status to Gedeptin™, the Company's lead product candidate (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.
"We are so pleased to have received the orphan drug designation for Gedeptin, which could potentially improve the patient outcomes of currently very difficult to treat diseases," said President of PNP Therapeutics Jim Fuqua. "I am so proud of the outstanding work of the two cofounders Drs. Eric Sorscher and Bill Parker, who have been instrumental in this world-class scientific discovery and prospective clinical use."
The orphan drug designation is awarded to drugs designed to treat a rare disease or condition that affects fewer than 200,000 people in the U.S., and it is applied specifically to novel therapeutics that represent a major improvement. Orphan drug status provides regulatory incentives, reduced fees, and a more rapid review by the FDA, and stipulates that competing therapies can be blocked from the market for up to seven years. Additionally, this status qualifies the drug sponsor for various development incentives, including tax credits for qualified clinical testing.
PNP Therapeutics has recently completed a phase I clinical trial to examine the safety and efficacy of Gedeptin in the treatment of head and neck cancer. In this trial, there were no major toxicities associated with the use of Gedeptin, and importantly, there were significant tumor responses in patients treated with the highest doses of Gedeptin. The results of this trial were recently published in the April 21, 2015, issue of Annals of Oncology.
PNP Therapeutics is currently seeking a partner to continue the clinical development of this novel therapy for the treatment of head and neck cancers and other solid tumors.
SOURCE PNP Therapeutics Inc.