Navigation Links
FDA Grants Soligenix Fast Track Designation for OrbeShield(TM) for the Reduction of Mortality Associated with Gastrointestinal Acute Radiation Syndrome (GI ARS)

PRINCETON, N.J., Jan. 29, 2013 /PRNewswire/ -- Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a development stage biopharmaceutical company, announced today that its OrbeShieldTM (oral beclomethasone 17,21-dipropionate or oral BDP) development program for the treatment of GI ARS has received "Fast Track" designation from the U.S. Food and Drug Administration (FDA). Soligenix has also previously received Orphan Drug designation from the FDA for oral BDP for the prevention of death following a potentially lethal dose of total body irradiation during or after a radiation disaster.

Fast track is a designation that the FDA reserves for a drug intended to treat a serious or life- threatening condition and one that demonstrates the potential to address an unmet medical need for the condition. Fast track designation is designed to facilitate the development and expedite the review of new drugs. For instance, should events warrant, Soligenix will be eligible to submit a new drug application (NDA) for OrbeShieldTM on a rolling basis, permitting the FDA to review sections of the NDA prior to receiving the complete submission.  Additionally, NDAs for fast track development programs ordinarily will be eligible for priority review, which imparts an abbreviated review time of six months. 

"There are no FDA approved therapies for the treatment of GI ARS," stated Christopher J. Schaber , PhD, President & Chief Executive Officer of Soligenix. "The FDA's action in granting fast track designation is a validation of BDP's potential to address this life-threatening, unmet medical need.  We look forward to working closely with the FDA, as well as with the National Institute of Allergy and Infectious Disease (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA) to potentially expedite the OrbeShieldTM development program."

About GI ARS

ARS occurs after toxic radiation exposure and involves several organ systems, notably the bone marrow the GI tract and later the lungs. In the event of a nuclear disaster or terrorist detonation of a nuclear bomb, casualties exposed to >2 Gy are at high risk for development of clinically significant ARS. Exposure to high doses of radiation exceeding 10-12 Gy causes acute GI injury which can result in death in 5-15 days.  The GI tract is highly sensitive due to the requirement for incessant proliferation of crypt stem cells and production of mucosal epithelium. The extent of injury to the bone marrow and the GI tract are the principal determinants of survival after exposure to TBI.  Although the hematopoietic syndrome has the potential to be rescued by bone marrow transplantation or growth factor administration, there is no established treatment or preventive measure for the GI damage that results from high-dose radiation exposure. Therefore, there is an urgent need to develop specific medical countermeasures against the lethal pathophysiological manifestations of radiation-induced GI injury.

About OrbeShieldTM

OrbeShieldTM contains BDP, a highly potent, topically active corticosteroid that has a local effect on inflamed tissue. OrbeShieldTM is formulated for oral administration in GI ARS patients as a single product consisting of two tablets; one tablet is intended to release BDP in the proximal portions of the GI tract and the other tablet is intended to release BDP in the distal portions of the GI tract.  BDP has been marketed in the United States and worldwide since the early 1970s as the active pharmaceutical ingredient in inhalation products for the treatment of patients with allergic rhinitis and asthma. Oral BDP may also have application in treating other GI disorders characterized by severe inflammation such as Crohn's disease and radiation enteritis.

About Soligenix, Inc.

Soligenix is a development stage biopharmaceutical company developing products to treat serious inflammatory diseases where there remains an unmet medical need, as well as developing several biodefense vaccines and therapeutics. Soligenix is developing proprietary formulations of oral BDP (beclomethasone 17,21-dipropionate) for the prevention/treatment of gastrointestinal disorders characterized by severe inflammation, including pediatric Crohn's disease (SGX203), acute radiation enteritis (SGX201) and chronic Graft-versus-Host disease (orBec®), as well as developing its novel innate defense regulator (IDR) technology SGX942 for the treatment of oral Mucositis.  

Through its BioDefense Division, Soligenix is developing countermeasures pursuant to the Biomedical Advanced Research and Development Authority (BARDA) Strategic Plan of 2011-2016 for inclusion in the US government's Strategic National Stockpile. Soligenix's lead biodefense products in development are a recombinant subunit vaccine called RiVax™, which is designed to protect against the lethal effects of exposure to ricin toxin and VeloThrax™, a vaccine against anthrax exposure. RiVax™ has been shown to be well tolerated and immunogenic in two Phase 1 clinical trials in healthy volunteers. Both RiVax™ and VeloThrax™ are currently the subject of a $9.4 million National Institute of Allergy and Infectious Diseases (NIAID) grant supporting development of Soligenix's new vaccine heat stabilization technology known as ThermoVax™. Soligenix is also developing OrbeShield™ for the treatment of gastrointestinal acute radiation syndrome (GI ARS) under a $600,000 NIAID Small Business Innovation Research (SBIR) grant. OrbeShieldTM has previously demonstrated statistically significant preclinical survival results in two separate canine GI ARS studies funded by the NIH.

For further information regarding Soligenix, Inc., please visit the Company's website at

This press release contains forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities. Statements that are not historical facts, such as "anticipates," "believes," "intends," or similar expressions, are forward-looking statements. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements. Soligenix cannot assure you that it will be able to successfully develop or commercialize products based on its technology, particularly in light of the significant uncertainty inherent in developing vaccines against bioterror threats, manufacturing and conducting preclinical and clinical trials of vaccines, and obtaining regulatory approvals, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further grants and awards, maintain its existing grants which are subject to performance, enter into any biodefense procurement contracts with the US Government or other countries, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K. Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

SOURCE Soligenix, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. New Jersey Health Foundation Awards First Two Innovation Stage Funding Grants
2. Artemis Diagnostics awarded two grants from Technology Strategy Board to develop cancer imaging technology
3. New Jersey Health Foundation Commits $2 Million to Fund Grants
4. FDA Grants Orphan Drug Status To Morphoteks Amatuximab (MORAb-009)
5. FDA Grants Soligenix Fast Track Designation for SGX203 for the Treatment of Pediatric Crohns Disease
6. ViiV Healthcare commits nearly £4M in Positive Action for Children Fund grants for programmes focused on alleviating burden of HIV on women and children
7. Nektar Announces that FDA Grants Fast Track Designation to Etirinotecan Pegol (NKTR-102) for the Treatment of Metastatic Breast Cancer
8. As Global Telemedicine Market Reaches $2.5 Billion, Industry Leaders Gather in San Diego to Discuss Grants, Funding, Vendor Selection, Credentialing, and More
9. EMA Grants Orphan Designation to Edison Pharmaceuticals for EPI-743 for Treatment of Leigh Syndrome
10. Neuralstem Grants First Licenses For CNS Therapy Surgical Devices
11. U.S. FDA Grants Priority Review to Bedaquiline (TMC207) for Multi-Drug Resistant Tuberculosis Treatment
Post Your Comments:
(Date:11/29/2015)... 2015  The GE Health Cloud 1 was unveiled ... North America (RSNA) meeting in ... the new cloud ecosystem and its applications will connect radiologists ... and multidisciplinary teams – both inside and outside the hospital ... of GE. "As the digital industrial leader, we are betting ...
(Date:11/29/2015)... CORALVILLE, Iowa , Nov. 29, 2015 /PRNewswire/ ... in ultrasound guidance technology at the Radiological Society ... conference in Chicago November ... guidance system is designed to offer customers unrivaled ... outcomes. --> ...
(Date:11/29/2015)...  National Decision Support Company (NDSC) continues to ... notable statewide implementations. As a result, ordering providers ... more than 1 million times per month—all from ... provides real-time feedback on the most appropriate imaging ... implemented at over 100 healthcare systems nationally, representing ...
Breaking Medicine Technology:
(Date:11/29/2015)... ... November 29, 2015 , ... While conventional walkers afford considerable help with ... to exercise weights. Fortunately, an inventor from Uniontown, Pa., has found a way to ... the benefits of a standard walker to improve the user’s quality of life. To ...
(Date:11/29/2015)... ... ... Doctors who missed a case of mesothelioma in a 70-year-old Japanese truck driver ... a diagnosis, especially in people exposed to asbestos. Surviving Mesothelioma has just posted details ... , Researchers at Gifu Prefectural Tajimi Hospital in Japan say the patient complained ...
(Date:11/29/2015)... ... November 29, 2015 , ... ProStatic Analog Distortion from ... designed specially for Final Cut Pro X. FCPX users can now ... modification controls. Destoying and creating chaotic distortion is now quick and simple, putting ...
(Date:11/29/2015)... ... 29, 2015 , ... Effective immediately, every single IguanaMed scrub style will be ... Target is offering a “Buy One Scrub Set, Get the 2nd Scrub Set 50% ... IguanaMed at a discounted price. , IguanaMed’s mission is to outfit every ...
(Date:11/29/2015)... ... November 29, 2015 , ... Key Housing, a top-rated ... announce their December, 2015, featured apartment community: Epic. In showcasing this featured apartment community ... the tight Bay Area rental market to efficiently find housing suitable to their needs ...
Breaking Medicine News(10 mins):