Rationally-designed, D-conformation Antimicrobial Peptides as Novel Antibacterial Drug Candidates for the Treatment of Multi-drug-resistant Bacterial

Award Information
Agency: Department of Defense
Branch: Navy
Contract: N00014-11-C-0195
Agency Tracking Number: N09A-033-0173
Amount: $493,619.00
Phase: Phase II
Program: STTR
Solicitation Topic Code: N09-T033
Solicitation Number: 2009.A
Timeline
Solicitation Year: 2009
Award Year: 2011
Award Start Date (Proposal Award Date): 2011-01-14
Award End Date (Contract End Date): N/A
Small Business Information
12635 Montview Blvd. Suite 100, Aurora, CO, 80045-
DUNS: 018876967
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 Robert Hodges
 Principal Investigator
 (303) 724-3253
 robert.hodges@uchsc.edu
Business Contact
 David DeLong
Title: CEO
Phone: (303) 828-6762
Email: dd.bio.336@comcast.net
Research Institution
 University of Colorado, Denver
 Robert Hodges
 13001 E 17th Place
Aurora, CO, 80045-
 (303) 724-3253
 Nonprofit college or university
Abstract
The goal of this Navy Phase II STTR project is to identify and develop a D-conformation antimicrobial peptide as a novel, effective, and safe antibacterial drug candidate capable of entering human clinical trials. From a set of 4 uniquely designed analogs that exhibit superior in vitro biologic activity/safety data against clinical and drug-resistant gram-negative A. baumannii bacterial isolates, a lead compound will be identified and rapidly advanced into pilot and IND-enabling pharmacokinetic, pharmacologic and toxicokinetic research. The research plan is scheduled for up to 36 months and is expected to provide data necessary to initiate human clinical trials and, ultimately, provide the Navy, the DoD, and the civilian healthcare community with a novel and field-compatible solution to the problem of bacterial resistance to conventional antibiotics. More specifically, the sequential objectives of the plan are to 1) Quantify the lead compound; 2) Determine the tolerable in vivo dose to move into efficacy testing; 3) Confirm a stable formulation; 4) Identify the effective single and repeat doses; 5) Produce the GLP IND data in two species; 6) Transfer manufacturing technology to a GMP facility; and 7) Submit an approvable IND and identify a Phase 1 human clinical trial center (military).

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

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