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Topical Therapeutic to Promote Healing of Chronic Wounds

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41GM101869-01A1
Agency Tracking Number: R41GM101869
Amount: $219,306.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NIGMS
Solicitation Number: PA12-089
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
45 Beaver Rd
WESTON, MA 02493-1017
United States
DUNS: 808428689
HUBZone Owned: No
Woman Owned: Yes
Socially and Economically Disadvantaged: No
Principal Investigator
 (617) 638-5639
Business Contact
Phone: (781) 929-5604
Research Institution
BOSTON, MA 02215-
United States

 () -
 Nonprofit College or University

DESCRIPTION (provided by applicant): Chronic refractory, or non-healing, wounds or ulcerations of the extremities represent a major medical condition affecting millions of patients. A chronic wound is defined as a wound that does not show signs of significant healing, or progresses, after use of topical/surgical treatment measures for six months. Non-healing wounds affect 6.5 million patients, affecting nearly 2% of the U.S. population, with an annual cost to the healthcare system of 25 billion. These numbers are rising with the aging population and the increasing incidence of diabetes, a leading cause of refractory leg ulcers. Other common causes of chronic wounds include venous stasis ulcers, and decubitus ulcers which develop in immobilized patients. Current treatments for extremity (diabetic, venous stasis) or decubitus ulcers often do not produce sustained or complete healing. Among diabetics, over half of ulcers recur within three years, and 15% ultimately require amputations, with significant consequent disability. New therapeutic agents that promote complete wound closure are needed for this enormous health burden. The Principal Investigators have identified a drug (Arginine Butyrate, AB) which, when given parenterally, dramatically accelerates healing, including complete healing in a highly-refractory chronic wound population, sickle cell leg ulcers, [which heal 10-20 times more slowly than comparable decubitus or diabetic ulcers]. The parenterally-delivered drug had a benign safety profile. Although parenteral (IV) delivery via indwelling port devices was acceptable for the extremely severe population studied in the prior clinical trial, a topical delivery system would offer many feasibility advantages for broader application and not require delivery primarily in clinical facilities. Phoenicia Biosciences has developed an innovative prototype topical spray delivery system of the same drug. This first-in-class therapeutic should provide a highly significant impact on the suffering and economic burdenimposed by the growing health care problem of chronic wounds. The Aims of this Phase I application are: (I) Develop a new topical dendrimer hydrogel spray preparation of AB, and test the activity of the new topical preparation in two animal models of wound healing (a chronic wound healing model and diabetic chronic wound healing model); (II.) Perform CMC studies required for a new IND of the novel topical formulation of Arginine Butyrate. These IND enabling studies will allow this new therapeutic to be tested in clinical trials. PUBLIC HEALTH RELEVANCE PUBLIC HEALTH RELEVANCE: Chronic wounds or ulcerations of the extremities represent a major medical condition affecting 6.5 million patients (nearly 2% of the U.S. population), with an annual costof 25 billion in the USA alone. Current treatments for extremity (diabetic, venous stasis) ulcers or decubitus ulcers generally fail to yield satisfactory results. Phoenicia Biosciences has identified a drug which, when given parenterally, dramatically accelerates healing, including complete healing in a very- refractory chronic wound setting, and proposes in this Phase I application to refine development of a topical preparation of the same agent, to allow broader application to the refractory wound market.

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

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