TOPIC 323 PHASE I; DEVELOPMENT OF RADIATION MODULATORS FOR USE DURING RADIOTHERAP

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: N43CA130018
Agency Tracking Number: N43CA130018
Amount: $250,000.00
Phase: Phase I
Program: SBIR
Awards Year: 2013
Solicitation Year: 2013
Solicitation Topic Code: NCI
Solicitation Number: N/A
Small Business Information
TERAPIO
11412 Bee Cave Rd, Suite 100, AUSTIN, TX, 78738-
DUNS: 806143207
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 CHARLES CUNNINGHAM
 (512) 697-8179
 CCUNNINGHAM@TERAPIO.COM
Business Contact
 CHARLES CUNNINGHAM
Phone: (512) 697-8179
Email: CCUNNINGHAM@TERAPIO.COM
Research Institution
 Stub
Abstract
Oral mucositis (OM) is a common side effect in oncology patients receiving radiation treatment. Mucosal breakdown causes pain which leads to increased use of narcotic analgesics and restriction of food intake. OM often progresses to septicemia, increasinghospital stays and costs, and ultimately discontinuation of radiotherapy. This impacts overall effectiveness of cancer therapy so development of an agent for prevention and treatment of OM is clearly an unmet need. Terapio is developing a drug, RLIP76-Proteoliposome (RLIP76-PL), as a radiation countermeasure. When administered systemically, RLIP76-PL dramatically improves survival in a mouse model of whole body radiation, leading to the hypothesis that it could be beneficial as a local application in treating specific radiation toxicities such as OM. This proposed research will test that hypothesis. In Specific Aim #1, the current formulation of RLIP76-PL will be modified to be used as a topical mouthwash. In Aim #2, the efficacy of the topical formulation of RLIP76-PL will be tested in a hamster model to evaluate its effectiveness in reducing the severity of OM after irradiation. Finally, in Specific Aim #3, systemic absorption of mucosally-applied RLIP76-PL will be investigated to guide future studies in atumor model to establish that RLIP76-PL is not tumor-protective. PUBLIC HEALTH RELEVANCE

* information listed above is at the time of submission.

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