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A TOPICAL NON STEROIDAL ANTI-INFLAMMATORY FOR ROSACEA

Award Number: R44AI062034
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/01/2004
PERIOD OF PERFORMANCE END DATE: 07/31/2014

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A TOPICAL NON STEROIDAL ANTI-INFLAMMATORY FOR ROSACEA - DESCRIPTION (provided by applicant): Rosacea is a chronic dermatological condition characterized by flushing, erythema, papules, pustules, inflammatory nodules and telangiectasia. Although disease etiology remains unclear, skin inflammation has been identified as the main contributor to disease pathology. Isoprenylcysteine (IPC) analogs represent a novel class of topical anti-inflammatory compounds being developed as therapeutic agents for rosacea. As part of the Phase II SBIR project, Signum identified a lead investigational new drug (IND)-candidate, SIG990 which demonstrated strong efficacy in in vitro and in vivo models. Through pharmacokinetic and safety pharmacology studies, the preclinical safety profile for SIG990 was established. In the renewal application, we propose to continue SIG990's development path towards clinical application and FDA approval by conducting further safety assessment of drug product toxicity. Upon completion of the proposed aims, Signum will enter SIG990 into the Phase III clinical trials. PUBLIC HEALTH RELEVANCE: Rosacea is a common, chronic skin disorder afflicting people all around the world, including ~16 million Americans. Currently available treatments have yielded mixed results, often leaving patients with significant levels of facial redness and inflammatory lesions. Successful pharmaceutical development of topical IPC analog anti-inflammatories will provide an important additional, and potentially better, therapeutic option for people suffering from rosacea associated redness.


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: 2013 ( Subtotal = $978,283 )
2013	2013	SIGNUM BIOSCIENCES INC	1 DEER PARK DRIVE	MONMOUTH JUNCTION	NJ	08852	MIDDLESEX	USA	Allergy and Infectious Diseases Research	000	6	6/28/2013	NON-COMPETING CONTINUATION	$978,283
														Subtotal = $978,283

Issue Date FY: 2012 ( Subtotal = $990,578 )
2012	2012	SIGNUM BIOSCIENCES INC	1 DEER PARK DRIVE	MONMOUTH JUNCTION	NJ	08852	MIDDLESEX	USA	Allergy and Infectious Diseases Research	000	5	6/28/2012	NON-COMPETING CONTINUATION	$990,578
														Subtotal = $990,578

Issue Date FY: 2011 ( Subtotal = $1,007,031 )
2011	2011	SIGNUM BIOSCIENCES INC	1 DEER PARK DRIVE	MONMOUTH JUNCTION	NJ	08852	MIDDLESEX	USA	Allergy and Infectious Diseases Research	000	4	8/1/2011	COMPETING CONTINUATION	$1,007,031
														Subtotal = $1,007,031

Issue Date FY: 2010 ( Subtotal = $838,194 )
2010	2010	SIGNUM BIOSCIENCES INC	1 DEER PARK DRIVE	MONMOUTH JUNCTION	NJ	08852	MIDDLESEX	USA	Allergy and Infectious Diseases Research	000	3	8/16/2010	NON-COMPETING CONTINUATION	$838,194
														Subtotal = $838,194

Issue Date FY: 2009 ( Subtotal = $785,099 )
2009	2009	SIGNUM BIOSCIENCES INC	1 DEER PARK DRIVE	MONMOUTH JUNCTION	NJ	08852	MIDDLESEX	USA	Allergy and Infectious Diseases Research	000	2	8/12/2009	COMPETING CONTINUATION	$785,099
														Subtotal = $785,099

Grand Total All Awards = $4,599,185

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A TOPICAL NON STEROIDAL ANTI-INFLAMMATORY FOR ROSACEA

Award Number: R44AI062034

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 07/01/2004

PERIOD OF PERFORMANCE END DATE: 07/31/2014

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