Radioprotection by use of Topical Lithium Formulations

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 1R41CA130191-01A2
Agency Tracking Number: CA130191
Amount: $121,528.00
Phase: Phase I
Program: STTR
Awards Year: 2009
Solicitation Year: 2009
Solicitation Topic Code: N/A
Solicitation Number: PHS2009-2
Small Business Information
CUMBERLAND PHARMACEUTICALS, INC.
CUMBERLAND PHARMACEUTICALS INC., 2525 WEST END AVE, STE 950, NASHVILLE, TN, 37203
DUNS: 069532880
HUBZone Owned: Y
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 DENNIS HALLAHAN
 (314) 362-9700
 DHALLAHAN@RADONC.WUSTL.EDU
Business Contact
 DIANE KEENEY
Phone: (615) 255-0068
Email: dkeeney@cumberlandpharma.com
Research Institution
 VANDERBILT UNIVERSITY
 VANDERBILT UNIVERSITY
Medical Center
NASHVILLE, TN, 37203 6869
 Nonprofit college or university
Abstract
DESCRIPTION (provided by applicant): Roughly 500,000 cancer patients are treated with radiotherapy each year. Acute and late sequelae of radiotherapy have a negative impact upon the quality of life of cancer survivors. These sequelae include proctitis, cystitis, esophageal stricture, cutaneous fibrosis plus others. We propose a novel means of preventing the acute and late radiation injury to normal tissues in these patients. Inhibitors of GSK-32 pathway can serve as radiation protective agents. Lithium can inhibit the GSK-32 pathway. Lithium-containing topical formulations are candidates for being effective radioprotectors by delivering the metal ion to the basal cell layer of epidermis (progenitor cells), preventing radio-induced apoptosis in normal cells in the skin overlying areas of radiation treatment. A total 12 prototype formulations will be screened in a radiation-induced injury porcine model. Six of the formulations will contain lithium succinate and the other six will contain lithium lactate. Two levels of the lithium salts will be screened (1% and 10%), each as an ointment, a gel, and an emulsion (cream). The best formulation(s) will be selected based on induction of proteins that enhance cell viability and inhibition of radiation-induced apoptosis. The efficacy and safety of selected formulations will be optimized in Phase II, supporting proof-of-concept for testing in humans and an IND submission to the FDA. PUBLIC HEALTH RELEVANCE: Over 500,000 cancer patients are treated with radiotherapy each year, and there are presently 10,000,000 cancer survivors in the US. Acute and late sequelae of radiotherapy have a negative impact upon the quality of life of cancer survivors. The goal of this proposal is to attenuate skin injury through development of a topical drug that markedly enhances the viability of the epidermis when administered before irradiation therapy to cancer patients undergoing targeted treatment of deeper tumors with radiation therapy.

* information listed above is at the time of submission.

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