In our previous grants, we have developed COG1410, a novel anti-inflammatory peptide with additional neuroprotective properties, for the treatment of Traumatic Brain Injury (TBI). Each year, TBI accounts for 50,000 deaths in the United States and of the 1,000,000 Americans treated and released from the Emergency Health Facilities, 230,000 survivors are disabled to the point that they will require significant care for the rest of their lives. In animal models of open and closed TBI, COG1410 was given 2 hours following the injury. Subsequent performance of COG1410 treated animals was significantly improved compared to controls on tests of balance, coordination, motor control, learning and memory. Based on the success in animals, our clinical goal is to intervene with a drug therapy in TBI patients that would lessen the severity of the response to TBI and thereby improve outcomes, like being capable of normal and independent activities of daily living without external assistance. This application is to perform all of the safety and toxicity studies required by the Food and Drug Administration (FDA) for submission and approval of an Investigational New Drug (IND) application for COG1410. In overview, we are required to synthesize high-quality COG1410 and use Good Laboratory Practices (GLP) methods to analyze COG1410 in different matrices, measure pharmacokinetics (PK) and toxicokinetics (TK) in rats and dogs using different amounts of COG1410 via intravenous injection and assess the safety of COG1410 in rats and dogs. Additional studies required of the IND are also detailed. The overall goal of this application is the successful completion of all studies, regulatory report submissions and necessary approvals that are needed to begin Phase 1 clinical trials of COG1410 in humans.

Public Health Relevance

We have developed COG1410, a novel anti-inflammatory peptide with additional neuroprotective properties, for the treatment of Traumatic Brain Injury (TBI). Each year, TBI accounts for 50,000 deaths in the United States and of the 1,000,000 Americans treated and released from the Emergency Health Facilities, 230,000 survivors are disabled to the point that they will require significant care for the rest of their lives. Currently, there are no FDA approved treatments for Traumatic Brain Injury and the focus of this application is to bring COG1410, an investigational new drug that does protect animals from TBI, to human clinical trials and to human TBI patients.

Agency
National Institute of Health (NIH)
Institute
National Institute on Aging (NIA)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
5R44AG020473-07
Application #
7907658
Study Section
Special Emphasis Panel (ZRG1-BDCN-A (11))
Program Officer
Buckholtz, Neil
Project Start
2002-07-15
Project End
2012-03-31
Budget Start
2010-09-01
Budget End
2012-03-31
Support Year
7
Fiscal Year
2010
Total Cost
$485,763
Indirect Cost
Name
Cognosci, Inc.
Department
Type
DUNS #
141881727
City
Research Triangle Park
State
NC
Country
United States
Zip Code
27709
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Kaufman, Nicholas A; Beare, Jason E; Tan, Arlene A et al. (2010) COG1410, an apolipoprotein E-based peptide, improves cognitive performance and reduces cortical loss following moderate fluid percussion injury in the rat. Behav Brain Res 214:395-401
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Tukhovskaya, Elena A; Yukin, Alexey Yu; Khokhlova, Oksana N et al. (2009) COG1410, a novel apolipoprotein-E mimetic, improves functional and morphological recovery in a rat model of focal brain ischemia. J Neurosci Res 87:677-82
Sarantseva, S V; Bol'shakova, O I; Timoshenko, S I et al. (2009) [Protein transduction domain peptide mediates delivery to the brain via the blood-brain barrier in Drosophila]. Biomed Khim 55:41-9
Hoane, Michael R; Kaufman, Nicholas; Vitek, Michael P et al. (2009) COG1410 improves cognitive performance and reduces cortical neuronal loss in the traumatically injured brain. J Neurotrauma 26:121-9
Shvartsman, A L; Sarantseva, S V; Solov'ev, K V et al. (2008) [Degeneration of growth cones in a culture of embryonic neurons of mouse with presenilin 1 gene knockout] Biofizika 53:1008-13

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