You are here

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

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: N43CA130014
Agency Tracking Number: N43CA130014
Amount: $249,997.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: NCI
Solicitation Number: N/A
Timeline
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
COLBY PHARMACEUTICAL COMPANY 5941 Optical Court Suite 223
San Jose, CA 95138-1400
United States
DUNS: 611495974
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 JEFFERY FAIRMAN
 (650) 333-3150
 JFAIRMAN@COLBYPHARMACEUTICALS.COM
Business Contact
 JEFFERY FAIRMAN
Phone: (650) 333-3150
Email: JFAIRMAN@COLBYPHARMACEUTICALS.COM
Research Institution
N/A
Abstract

Oral mucositis is a major complication of radiotherapy for the treatment of head and neck cancer and a major dose-limiting side effect. Our work has shown that intra-esophageal administration of plasmidlliposomes containing the transgene expressing humansuperoxide dismutase 2 (SOD2) (JVRSOD) protects the esophagus from radiation-induced esophagitis (a form of mucositis) in mice. The overall purpose of the Phase I section of this fast-track contract proposal is to complete the IND-enabling studies forthe use of JVRSOD as a prophylactic mouthwash to reduce andlor prevent oral mucositis in head and neck cancer patients undergoing radiation treatment. The Phase I Proposal specific aims are (1) dose optimization of JVRSOD in a mouse model for protectionfrom radiation-induced oral mucositis; (2) dosing schedule optimization of JVRSOD in the same mouse model for protection from radiation-induced oral mucositis; and (3) identification and qualification of a GMP manufacturing site. Under the Phase II Contract Proposal in this Fast-Track submission, an IND application for JVRSOD will be submitted to the FDA, cGMP JVRSOD will be manufactured, and it will be tested in humans for safety I efficacy in a Phase 1111 clinical trial with head and neck cancer patients undergoing standard of care radiation treatment PUBLIC HEALTH RELEVANCE

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

US Flag An Official Website of the United States Government