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Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R44DA013300-02
Agency Tracking Number: DA013300
Amount: $740,914.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: N/A
Solicitation Number: N/A
Solicitation Year: N/A
Award Year: 2002
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
United States
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (513) 475-6618
Business Contact
Phone: (513) 558-4274
Research Institution

DESCRIPTION (provided by applicant): The objective of this Phase II application
is to develop a sensitive quantitative biomarker of drug-induced neuronal
degeneration, particularly associated with drugs of abuse. We have shown that
during neuronal degeneration the neuronally localized protein MAP-tau is
proteolytically cleaved (C-tau) in patients with head trauma and stroke. We
have developed antibodies that specifically recognize C-tau. Employing C-tau
ELISA and immunohistochemistry (IHC) Phase 1 studies demonstrate that after a
neurotoxic dose of methamphetamine brain C-tau levels increase in a time
dependent manner in the rat. Additional studies demonstrate for the first time,
that MDMA ('ecstasy') is a neurotoxin utilizing our C-tau ELISA. Our
quantitative C-tau studies indicate that MDMA neurotoxicity is only 3 percent
of that seen after methamphetamine accounting for the inability of previous
studies to demosnstrate MDMA neurotoxicity. The proposed studies will validate
our C-tau neurotoxin biomarker by assessing the time course of neurotoxicity of
three street drugs (MDMA, PMA and PCP dust']), an environmental neurotoxin
(TMT) and a neurotoxicity 'Gold Standard'-kainic acid.
Specific Aim 1-Product Development: Perform quality control studies and
quality-controlled manufacturing of C-tau ELISA and IHC kits.
Specific Aim 2-Product Utilization: Determine if C-tau reliably quantifies
neurotoxicity caused by drugs of abuse and environmental neurotoxins.
Neurotoxic doses of drugs of abuse (MDMA, PMA, PCP), an environmental
neurotoxin (TMT) and kainic acid ('Gold Standard') will be administered and the
time course of neurotoxicity quantified by ELISA and anatomically localized by
C-tau IHC.

PROPOSED COMMERCIAL APPLICATION: Our objective is to develop a sensitive biomarker for quantifying drug-induced neuronal degeneration. The National Institute on Drug Abuse has indicated that "improved methods are needed for identifying, assessing and quantifying the nature and extent of neurotoxicity" of abused drugs. Currently, the primary method of identifying drug-induced neurotoxicity in animals is the selective silver stain method. This method is histochemical and non-quantitative. Our product will be both quantitative (ELISA) and more sensitive than available silver stain techniques for detecting drug-induced neurotoxicity employing immunohistochemistry. There are several markets for our product (C-tau ELISA and C-tau immunohistochemistry). Animal studies of neurotoxins, neurodegenerative diseases, head injury or stroke would be users of our C-tau technology. In the year 2000 Medline indicates there were 4,254 studies published in these areas for an estimated annual market size of $4.2 million dollars.

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

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