16 Jun 2017BIRMINGHAM, Ala. - 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.
CHP client signs an agreement to commercialize its 505(b)(2) asset for the treatment of Head and Neck Cancer
"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
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
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.
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