Selective Decorporation Agents for NIAID

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$3,000,000.00
Award Year:
2011
Program:
SBIR
Phase:
Phase II
Contract:
2R44AI079935-03
Award Id:
n/a
Agency Tracking Number:
R44AI079935
Solicitation Year:
2011
Solicitation Topic Code:
NIAID
Solicitation Number:
PA09-093
Small Business Information
278 DP Road Suite D, LOS ALAMOS, NM, -
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
147452275
Principal Investigator:
BENJAMIN WARNER
(505) 412-2345
warner@cpsci.com
Business Contact:
LORI PETERSON
(505) 661-2420
peterson@cpsci.com
Research Institute:
Stub




Abstract
DESCRIPTION (provided by applicant): This Phase II project continues the successful Phase I discovery of novel decorporation agents that are selective for radioactive strontium (Sr). This project consists of the necessary steps for submission of an Emergency Use Authorization (EUA) or Investigational New Drug (IND) application to the US FDA. A goal is to have orally- administered, GI-chelation formulations ready for an FDA application by the end of year for the Strategic National Stockpile (SNS). This project is guided by the Guidance for Industry: Internal Radioactive Contamination -Development of Decorporation Agents. Sr-90 is easily obtained by terrorists;radioactive Sr-decorporation is a very high DHHS / NIH / NIAID / DAIT priority and treatments for Sr-90 exposure remain a critical need for the SNS. Sr-90 and its daughter yttrium-90 are beta emitters that deposit their energy in the body. Sr-90 is readily absorbed by both respiratory and GI routes and up to 50% of a dose will be deposited in bone. Current GI absorption blocking agents, such as aluminum phosphate, are of low effectiveness, although they are recommended for clinical use. There are no Sr-specific decorporation agents available. PUBLIC HEALTH RELEVANCE: This Phase II project continues the successful Phase I discovery of novel decorporation agents that are selective for radioactive strontium. A goal is to have orally-administered, GI-chelation formulations ready for an FDA application by the end of year for the Strategic National Stockpile. Sr-90 is easily obtained by terrorists; radioactive Sr-decorporation is a very high priority and treatments for Sr-90 exposure remain a critical need for the SNS.

* information listed above is at the time of submission.

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