OrbeShield Development Program
Award Notice Posted
- Solicitation number
- Not on record
- Agency
-
Immediate Office of the Secretary
Department of Health and Human Services
- Awarded
- to Soligenix, Inc.
- Set-aside
- No set-aside
Opportunity facts
- Contract number
- HHSO100201300023C Federal contract award
- NAICS code
- 541711 Research and Development in Biotechnology
- PSC
- Not on record
Notice details come from SAM.gov. Updated .
Notice text
Added: Sep 23, 2013 3:09 pm The work plan will detail the key studies in the OrbeShieldTM (oral beclomethasone 17,21-dipropionate or BDP) development program. The focus of the work plan is the evaluation of OrbeShieldTM in pre-clinical and non-clinical studies. A rhesus macaque non-human primate (NHP) total body irradiation (TBI) model of the gastrointestinal acute radiation syndrome (GI-ARS) will be established and will be used to test the efficacy of OrbeShield TM in support of Food and Drug Administration (FDA) regulatory approval under the animal Rule. An option of the work plan proposes to conduct additional pre-clinical and non-clinical studies, drug product manufacturing, as well as establish and study OrbeShieldTM in a rhesus NHP partial body irradiation (PBI) model of the GI-ARS as additional support for FDA regulatory approval.
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