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Development of a novel SP-B peptide lung surfactant

Award Number: R44HL080775
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 05/01/2005
PERIOD OF PERFORMANCE END DATE: 07/31/2015

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Development of a novel SP-B peptide lung surfactant - DESCRIPTION (provided by applicant): This competitive renewal SBIR proposal extends our current Phase II translational research on novel synthetic lipid/peptide lung surfactants containing the highly active Super Mini-B (S-MB) peptide incorporating crucial functional regions of human surfactant protein (SP)-B, the most active apoprotein in biologic surfactant. Our initial Phase II grant focused on S-MB synthesized by solid-state chemistry, and documented the high activity of synthetic Minisurf" surfactant containing solid-state S-MB combined with lipids. This renewal application continues the commercial development of Minisurf" surfactant. This proposal will scale-up the production of the S-MB peptide and the Minisurf" surfactant product, develop effective QA/QC methods for analyzing the S-MB peptide and Minisurf" surfactant product, and demonstrate biological equivalency to laboratory research scale batches of Minisurf" surfactant. Pilot lots of the Minisurf" surfactant product will be manufactured and teste to ensure that the process is robust, the analytical controls are appropriate and the efficacy is maintained. Samples from selected pilot lots of Minisurf" surfactant will be placed on stability and sent to a contractor to conduct GLP-compliant pharmacology and toxicology studies. The proposal also provides for active consultation with the FDA during the grant to facilitate successful IND preparation. Successful execution of these activities will lead to the development of a novel, commercially-attractive Minisurf" synthetic surfactant product having significant advantages in manufacturing economy, activity, and inhibition resistance over current animal and synthetic surfactant drugs.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2014 ( Subtotal = $1,051,147 )
2014	2014	MOLECULAR EXPRESS, INC	1381 WARNER AVE, SUITE C	TUSTIN	CA	90061		USA	Lung Diseases Research	000	6	8/16/2014	NON-COMPETING CONTINUATION	$1,051,147
														Subtotal = $1,051,147

Issue Date FY: 2013 ( Subtotal = $957,467 )
2013	2013	MOLECULAR EXPRESS, INC	1381 WARNER AVE, SUITE C	TUSTIN	CA	90061		USA	Lung Diseases Research	000	5	7/22/2013	NON-COMPETING CONTINUATION	$957,467
														Subtotal = $957,467

Issue Date FY: 2012 ( Subtotal = $953,604 )
2012	2012	MOLECULAR EXPRESS, INC	1381 WARNER AVE, SUITE C	TUSTIN	CA	90061		USA	Lung Diseases Research	000	4	8/16/2012	COMPETING CONTINUATION	$953,604
														Subtotal = $953,604

Issue Date FY: 2009 ( Subtotal = $625,381 )
2009	2009	MOLECULAR EXPRESS, INC	1381 WARNER AVE, SUITE C	TUSTIN	CA	90061		USA	Lung Diseases Research	000	3	6/19/2009	NON-COMPETING CONTINUATION	$625,381
														Subtotal = $625,381

Issue Date FY: 2008 ( Subtotal = $585,036 )
2008	2008	MOLECULAR EXPRESS, INC	1381 WARNER AVE, SUITE C	TUSTIN	CA	90061		USA	Lung Diseases Research	000	2	9/17/2008	COMPETING CONTINUATION	$585,036
														Subtotal = $585,036

Grand Total All Awards = $4,172,635

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Development of a novel SP-B peptide lung surfactant

Award Number: R44HL080775

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 05/01/2005

PERIOD OF PERFORMANCE END DATE: 07/31/2015

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