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Hiltonol provides potent neuroprotection from ischemic brain injury in stroke.

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
Program Year/Program:
2013 / SBIR
Agency Tracking Number:
R43NS077615
Solicitation Year:
2013
Solicitation Topic Code:
NINDS
Solicitation Number:
PA12-088
Small Business Information
ONCOVIR, INC.
3203 CLEVELAND AVE NW WASHINGTON, DC 20008-
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 1
Fiscal Year: 2013
Title: Hiltonol provides potent neuroprotection from ischemic brain injury in stroke.
Agency: HHS
Contract: 1R43NS077615-01A1
Award Amount: $257,382.00
 

Abstract:

DESCRIPTION (provided by applicant): Brain ischemia is a leading cause of morbidity and mortality in the United States. We seek to develop therapeutics to reduce the extent of damage and functional impairment resulting from ischemic injury to the brain, anarea of significant unmet medical need. We have shown that ligand activation of the Toll-like receptor (TLR) family of pattern recognition receptors provides significant protection against ischemic brain injury. In this proposal we seek to evaluate Hiltonol(R), a synthetic dsRNA TLR3 ligand as a prophylactic neuroprotectant against stroke injury. Hiltonol is a clinical stage therapeutic being tested in multiple Phase I/II clinical trials that consists of polyinosinic-polycytidylic acid stabilized by oly-L-lysine and carboxymethylcellulose (poly-ICLC). In our preliminary data we show that systemic administration of Hiltonol protects the brain and kidneys against subsequent injury in mouse models of stroke and renal ischemia. A drug of this type would have considerable clinical impact in at-risk populations. Armed with our unique understanding of TLR-induced neuroprotection and a rich background in Hiltonol clinical development, our team will evaluate the feasibility of Hiltonol as a candidate stroke therapeutic. Our specific goals for this Phase I SBIR are to advance Hiltonol through preclinical studies using a mouse middle cerebral artery occlusion (MCAO) model and identify translational biomarkers in the mouse that will position us for phase II stroke studies in nonhuman primates (NHPs, rhesus macaques). The following specific aims are proposed: Aim 1. Determine the therapeutic window and time window of effectiveness of Hiltonol preconditioning in a mouse MCAO model of focal ischemia. Aim 2. Evaluate the duration of protection with Hiltonol. Aim 3. Validate translational biomarkers in mice. PUBLIC HEALTH RELEVANCE PUBLIC HEALTH RELEVANCE: Brain ischemia is a leading cause of morbidity and mortality in the United States and can occur both acutely orin response to loss of blood flow secondary to cardiovascular surgery. This proposal seeks to advance Hiltonol, a toll-like receptor 3 ligand that has shown efficacy as a prophylactic treatment, through preclinical studies using a mouse model of stroke and to identify potential biomarkers for Phase II studies in nonhuman primates.

Principal Investigator:

Andres M. Salazar
202-341-1726
asalazar@oncovir.com

Business Contact:

Frances R. Bahjat
503-494-2096
bahjat@ohsu.edu
Small Business Information at Submission:

ONCOVIR, INC.
3203 CLEVELAND AVE NW WASHINGTON, DC 20008-

EIN/Tax ID: 152212503
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No