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Evaluation Of A Novel Connexin-Based Peptide For The Treatment Of Diabetic Wounds

Award Number: R44DK080567
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/15/2007
PERIOD OF PERFORMANCE END DATE: 04/30/2017

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Evaluation Of A Novel Connexin-Based Peptide For The Treatment Of Diabetic Wounds - DESCRIPTION (provided by applicant): According to the ADA, 25.8 million children and adults have diabetes. Diabetics have an increased risk of complications such as heart disease and are prone to impaired wound healing. A major cause of morbidity and hospitalization is diabetic foot ulceration (DFUs) that may result in infection, gangrene, amputations requiring prolonged hospitalization, costly treatments, and can significantly impair a patient's quality of life. The cost of DFU's to the US healthcare system is over $10 Billion annually. Diabetic wounds tend to remain stalled in the initial inflammatory phase of wound healing and are generally unresponsive to conventional treatments. Current treatment approaches including debridement, pressure off-loading, infection control, negative pressure, and skin substitutes tend to have marginal efficacy and high cost. A large unmet need exists for an easier and more effective treatment. FirstString Research, Inc. (FSR), a clinical stage biotech company, is advancing the development of novel bioengineered peptides based on the c-terminus of connexin proteins; a protein with important roles in multiple aspects of the wound healing process. A lead peptide ¿CT1 (25 amino acids) based on connexin 43 (Cx43) has demonstrated a unique capability of switching the body's own healing response from inflammation and scarring to a healthy regenerative stage. FSR, with the assistance of Phase I and II SBIR/STTR grants, has developed ACT1 in a topical product called Granexin(tm) Gel; obtained IND approval; and demonstrated its MOA, safety, and efficacy in a Phase I (N=48) and two (2) Phase II (N=92 per trial) clinical trials. Granexin(tm) Gel has been shown to be safe and efficacious with no evidence of immunogenicity. FSR proposes to conduct a Phase 2b human (N=180) clinical trial to evaluate safe and efficacy of Granexin(tm) Gel for treating DFUs. This trial will involve 3 grous to receive: Granexin(tm) Gel (100 ¿M ¿CT1) + Standard of Care (SOC); Granexin(tm) Gel (200 ¿M ¿CT1) + SOC; or Vehicle Gel + SOC. Due to ¿CT1's unique MOA, we hypothesize that Granexin(tm) Gel will significantly accelerate wound closure in DFU patients, when compared to Vehicle + SOC. The hypothesis will be tested through the following specific aims: To evaluate the safety and efficacy of Granexin(tm) Gel administered topically to Diabetic Foot Ulcer. The primary endpoint will be the incidence of 100% wound closure from Baseline to Week 12. The secondary endpoints will include mean percent wound closure at 4 weeks, subject self-assessment of intensity of pain (till Week 12), time to 50% and 100% wound closure. The safety variable will be the incidence of treatment related Adverse Events. Further clinical success achieved with this project will enable the advancement Granexin(tm) Gel toward pivotal Phase 3 trials, obtaining FDA's approval, and subsequent product commercialization, thus laying the foundation for a novel therapeutic for patients suffering from DFUs.


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: 2017 ( Subtotal = $0 )
2017	2016	FIRSTSTRING RESEARCH, INC	300 WEST COLEMAN BOULEVARD SUITE 203	MOUNT PLEASANT	SC	29464	CHARLESTON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	6	7/21/2017	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2016 ( Subtotal = $997,264 )
2016	2016	FIRSTSTRING RESEARCH INC	5300 Intl Blvd Ste 207	Charleston	SC	29418	CHARLESTON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	6	5/4/2016	NON-COMPETING CONTINUATION	$997,264
														Subtotal = $997,264

Issue Date FY: 2015 ( Subtotal = $996,533 )
2015	2015	FIRSTSTRING RESEARCH INC	5300 Intl Blvd Ste 207	Charleston	SC	29418	CHARLESTON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	5	6/29/2015	NON-COMPETING CONTINUATION	$996,533
														Subtotal = $996,533

Issue Date FY: 2014 ( Subtotal = $999,289 )
2014	2014	FIRSTSTRING RESEARCH INC	5300 Intl Blvd Ste 207	Charleston	SC	29418	CHARLESTON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	5/5/2014	COMPETING CONTINUATION	$999,289
2014	2014	FIRSTSTRING RESEARCH INC	1046 OAKCREST DRIVE	CHARLESTON	SC	29412	CHARLESTON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	4	5/7/2014	COMPETING CONTINUATION	$0
														Subtotal = $999,289

Issue Date FY: 2011 ( Subtotal = $623,674 )
2011	2011	FIRSTSTRING RESEARCH INC	5300 Intl Blvd Ste 207	Charleston	SC	29418	CHARLESTON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	4/1/2011	NON-COMPETING CONTINUATION	$323,674
2011	2011	FIRSTSTRING RESEARCH INC	5300 Intl Blvd Ste 207	Charleston	SC	29418	CHARLESTON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	3	7/4/2011	SUPPLEMENT FOR EXPANSION	$300,000
														Subtotal = $623,674

Issue Date FY: 2010 ( Subtotal = $317,414 )
2010	2010	FIRSTSTRING RESEARCH INC	5300 Intl Blvd Ste 207	Charleston	SC	29418	CHARLESTON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	3/15/2010	COMPETING CONTINUATION	$317,414
														Subtotal = $317,414

Grand Total All Awards = $3,934,174

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Evaluation Of A Novel Connexin-Based Peptide For The Treatment Of Diabetic Wounds

Award Number: R44DK080567

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/15/2007

PERIOD OF PERFORMANCE END DATE: 04/30/2017

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