Radioprotection by use of Topical Lithium Formulations

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$121,528.00
Award Year:
2009
Program:
STTR
Phase:
Phase I
Contract:
1R41CA130191-01A2
Award Id:
93495
Agency Tracking Number:
CA130191
Solicitation Year:
n/a
Solicitation Topic Code:
n/a
Solicitation Number:
n/a
Small Business Information
CUMBERLAND PHARMACEUTICALS INC., 2525 WEST END AVE, STE 950, NASHVILLE, TN, 37203
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
069532880
Principal Investigator:
DENNIS HALLAHAN
(314) 362-9700
DHALLAHAN@RADONC.WUSTL.EDU
Business Contact:
DIANE KEENEY
() -
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, cys titis, 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 i n 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 le vels 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 developmen t 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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