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Beclomethasone post exposure therapy for gastrointestinal acute radiation…

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
Program Year/Program:
2012 / SBIR
Agency Tracking Number:
R43AI100417
Solicitation Year:
2012
Solicitation Topic Code:
NIAID
Solicitation Number:
PA09-093
Small Business Information
DOR BIOPHARMA, INC.
29 Emmons Dr PRINCETON, NJ -
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 1
Fiscal Year: 2012
Title: Beclomethasone post exposure therapy for gastrointestinal acute radiation syndrom
Agency: HHS
Contract: 1R43AI100417-01
Award Amount: $600,000.00
 

Abstract:

DESCRIPTION (provided by applicant): This proposal concerns the use of beclomethasone dipropionate (BDP) as a post-exposure drug therapy having the potential to mitigate the gastrointestinal (GI) injury associated with acute radiation syndrome (ARS) following exposure to intense ionizing radiation. ARS occurs after toxic radiation exposure and involves at least several organ systems, primarily resulting in toxicity to the bone marrow (hematopoietic [HP] syndrome) and the GI (GI-ARS). In the event of a nuclear disaster or terrorist detonation of a nuclear bomb, casualties exposed to gt2 Gray (Gy) are at high risk for development of clinically significant ARS. Exposure to high doses of radiation exceeding 10-12 Gy causes acute gastrointestinal injury which canresult in death in 5-10 days. Thus, the extent of injury to the bone marrow and the GI tract are the principal determinants of survival after exposure to total- body irradiation (TBI). Although lethal hematopoietic injury can be rescued by bone marrow transplantation and several therapeutic drugs, there is no treatment or preventive measure for GI damage that occurs after high dose radiation. We evaluated an oral formulation of beclomethasone dipropionate (BDP), a mucosally active glucocorticoid, as a treatment of dogs to mitigate acute GI syndrome. The primary result that justifies further study of this drug in the GI-ARS is the survival benefit in dogs that have received BDP therapy starting 2 hours following lethal TBI. Preliminary results also suggest BDP efficacy starting at 24 hours after TBI. With this application, we are proposing further evaluation of the oral drug in beagle dogs with a focus on intervention at least 24 hours after TBI. The dog is one of the crucial large animal models that will aid in establishing efficacy of BDP (or other drugs) for eventual FDA licensure under the Animal Rule. We envision future studies that would occur in mouse models on refinement of the putative mechanisms of BDP in GI-ARS, as wells as studies of orally administered BDP in non-human primates. PUBLIC HEALTH RELEVANCE: This proposal concerns the use of beclomethasone dipropionate (BDP) as a post-exposure drug therapy having the potential to mitigate the gastrointestinal (GI) injury associated with acute radiation syndrome (ARS) following exposure to intense ionizing radiation. Exposure to high doses of radiation exceeding 10-12 Gy causes acute gastrointestinal injury which can result in death in 5-10 days. In this project, we are proposing evaluation of orally administered BDP in beagle dogs with a focus on intervention at least 24 hours after lethal total body irradiation (TBI).

Principal Investigator:

Kevin J. Horgan
310-206-3580
khorgan@soligenix.com

Business Contact:

Alison Bawden
352-318-1898
abawden@soligenix.com
Small Business Information at Submission:

SOLIGENIX, INC.
29 Emmons Dr PRINCETON, NJ -

EIN/Tax ID: 141150502
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No