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Rapidly boosting innate immunity in the lungs to protect against pneumonia

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R44AI092904-02A1
Agency Tracking Number: R44AI092904
Amount: $1,305,671.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NIAID
Solicitation Number: PA12-088
Solicitation Year: 2013
Award Year: 2013
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
3900 Essex Lane #250
Houston, TX 77027-
United States
DUNS: 786704143
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (713) 579-9226
Business Contact
Phone: (713) 579-9226
Research Institution

DESCRIPTION (provided by applicant): Pneumonia can be caused by a variety of pathogenic organisms including bacteria, fungi and viruses and is the leading cause of death worldwide. Even in developed countries, pneumonia continues to be the leading cause of death from infection and a serious complication for patients being treated for other diseases. The threat of lung infections is elevated when there is a decreased level of host resistance (e.g. immunocompromised cancer patients) and when there is an increased level of pathogen exposure (e.g. pandemics, bioterror, and biowarfare). Acute leukemia patients are currently some of the most at-risk patients, as they are faced with significant immunocompromise resulting from their cancer treatments. Many times infectious complications prevent the full cancer treatment plan from being completed. As a result, each year an estimated 44,700 leukemia patients spend more than one-half billion dollars on a range of treatments in an effort to prevent pneumonia. Despite this expenditure, pneumonia continues to occur in 15-20% of acute leukemia patients. Pulmotect's Solution: Pulmotect has identified and is developing a novel, proprietary technology to address the risks of inhaled microbes. Our therapeutic (PUL-042) is a combination of two Toll-like receptor (TLR) agonist ligands that stimulate the lung's own innate defense mechanisms to create a broad protection against invading pathogens thereby reducing and preventing infection. Supported in part by a successful Phase I SBIR, both in vitro and in vivo preclinical proof-of-concept experiments have been completed to validate this technology and further advance it to the clinic. It is in the most at-risk cancer patients where clinical proof-of- concept can be captured and support development for additional patient populations (transplant, ICU, bioterror, pandemic). The focus of this proposal is to accomplish key milestones that will advance this technology further towards commercialization and bridge to funding already securedfor Phase I and Phase II clinical trials. The project is organized into four Specific Aims that address the needed data, drug manufacturing, and approvals to bridge this technology to the clinic. PUBLIC HEALTH RELEVANCE PUBLIC HEALTH RELEVANCE:Pulmotect, Inc is developing novel therapeutics that stimulate the innate immune system to protect against infectious diseases, even in cases of severely compromised immunity. Proof-of-concept data has shown that this technology effectively protects against a broad range of inhaled pathogens. This project will provide significant data to help transition this technology from the lab to the clinic, where physicians are seeking better ways to prevent their patients from developing pneumonia.

* Information listed above is at the time of submission. *

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