News & Events
PNP Therapeutics Inc. Receives Orphan Drug Status for Gedeptin
June 16, 2015 - BIRMINGHAM, 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.
“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.
About PNP Therapeutics, Inc.
PNP Therapeutics Inc. is a clinical-stage, biopharmaceutical company engaged in the development of a platform technology and proprietary products for the treatment of cancer. At the center of PNP's Therapeutic System is Gedeptin, a vector encoding a patented enzyme (E. coli purine nucleoside phosphorylase) that has been shown to work with a variety of well-characterized nucleoside prodrugs generating active metabolites with high levels of anti-tumor activity. PNP Therapeutics is the exclusive licensee of a comprehensive collection of patents that broadly and specifically cover the Company's technology. These patents are owned jointly by the UAB Research Foundation and Southern Research of Birmingham. For additional information, visit www.pnptherapeutics.com.
This press release and any statements of representatives and partners of PNP Therapeutics Inc. (the “Company”) related thereto contain, or may contain, among other things, certain “forward-looking statements” as defined in the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to the Company’s plans, objectives, projections, expectations and intentions and other statements identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential” or similar expressions. These statements are based upon the current beliefs and expectations of the Company’s management and are subject to significant risks and uncertainties. Actual results may differ significantly from those set forth in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company’s control).
For inquiries, contact:
PNP Therapeutics, Inc.
15 Richard Arrington Jr. Blvd. North
Birmingham, Alabama, 35203-4121