Last Published:  07/31/19 10:05:30 AM (Central)
Responsible Element: Space Radiation (SR)
Status: Open
Description

Initial State of Gap:

Medical and dietary countermeasures for radiation-induced cardiovascular, cerebrovascular, and other degenerative pathologies will be evaluated starting with current standard of care clinical markers for monitoring space radiation induced late cardiovascular disease. An increasing body of evidence points to the potential role of chronic inflammation and oxidative stress in the etiology of these radiation-induced disease processes. SRPE will investigate the possibility of targeting these pathways for risk mitigation.   

Approach:

Medical and dietary countermeasures:  

 

Current efforts include in vitro evaluation of radioprotectors under the SBIR program and leveraging interagency efforts to assess the efficacy of medical countermeasures targeting multiple tissues and risks. A priority is to validate standard-of-care clinical protective measures against radiation-induced cardiovascular and cerebrovascular disease in chronic mixed field environments. Additional work will follow to identify and prioritize candidate radioprotective agents for mitigating cross-risk radiation adverse outcomes and evaluate efficacy in a model of combined stressors.

 

Medical countermeasures for consideration will need to meet the requirements of the FDA Animal Rule to demonstrate safety and efficacy when human studies are not feasible.

 

Under the FDA Animal Rule:

The Animal Rule states that FDA will rely on evidence from animal studies to provide substantial evidence of effectiveness only when all of the following four criteria, quoted below, are met:

1. There is a reasonably well-understood pathophysiological mechanism of the toxicity of the substance and its prevention or substantial reduction by the product;

2. The effect is demonstrated in more than one animal species expected to react with a response predictive for humans, unless the effect is demonstrated in a single animal species that represents a sufficiently well-characterized animal model for predicting the response in humans;

3. The animal study endpoint is clearly related to the desired benefit in humans, generally the enhancement of survival or prevention of major morbidity; and

4. The data or information on the kinetics and pharmacodynamics of the product or other relevant data or information, in animals and humans, allows selection of an effective dose in humans.

 

If all of these criteria are met, it is reasonable to expect the efficacy of the drug in animals to be a reliable indicator of its effectiveness in humans.

 

Target for Closure
  • Identification of indexed metrics to monitor therapeutic efficacy for cardiovascular, cerebrovascular, and other degenerative diseases due to space radiation exposure.
  • Identification of common pathway targets and candidate countermeasures.
  • Validation of biomarkers and countermeasures in a chronic mixed field environment in accordance with the FDA Animal Rule.
  • Evaluation of countermeasures in a combined stressors model in a chronic mixed field environment.
Mappings
Risk Risk of Cardiovascular Disease and Other Degenerative Tissue Effects From Radiation Exposure and Secondary Spaceflight Stressors
You are here! Gap Degen - 6: What are the most effective medical or dietary countermeasures to mitigate degenerative tissue risks? Are there common pathways that will benefit multiple tissues?
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Planned-Funded

Documentation:
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