HHS Recovery Act Recipient Reporting Readiness Tool
Step 4. Review and Copy the Grant Awards Data
TAGGS provides some – but not all – of the data needed for the Recipient Report. Recipients are responsible for directly collecting and reporting all required data to FederalReporting.gov. Data that HHS does not currently collect are highlighted in yellow. Do not copy this highlighted information. Please enter the appropriate data for your organization in these required fields. For assistance with entering these data please contact FederalReporting.gov.
You may capture the data HHS does provide by copying data from this screen and pasting it into the reporting format of your choice, such as the Excel spreadsheet template, the XML template, or by logging into the online form. For assistance with copying and pasting these data please e-mail our help desk at Readiness Help.
| Recipient Report: Grant or Loan | ||
| Prime Recipient |
| Reporting Information | ||
| Award Type | Award Number | Final Report |
| Grant | 5RC2DA028915-02 | Recipient responsible for this data |
| Award Recipient Information | ||
| Recipient DUNS Number | Recipient Account Number | Recipient Congressional District |
| 144004210 | Recipient responsible for this data | 2 |
| Award Information | ||
| Funding Agency Code | Awarding Agency Code | Award Date |
| 7529 | 7529 | 08-25-2010 |
| Amount of Award | Sub Account Number for Program Source (TAS) | |
| $ 2,769,478 | Recipient responsible for this data | |
| Program Source (TAS)* | CFDA Number | |
| 750908 | 93.701 | |
| Total Number of Sub Awards to Individuals | Total Amount of Sub Awards to Individuals | |
| Recipient responsible for this data | Recipient responsible for this data | |
| Total Number of Payments to Vendors less than $25,000/award | Total Amount of Payments to Vendors less than $25,000/award | |
| Recipient responsible for this data | Recipient responsible for this data | |
| Total Number of Sub Awards less than $25,000/award | Total Amount of Sub Awards less than $25,000/award | |
| Recipient responsible for this data | Recipient responsible for this data | |
| Award Description | ||
| DESCRIPTION (provided by applicant): Overdose and abuse of methamphetamine ((+)-METH), (+)-amphetamine ((+)-AMP), or (1)- methylenedioxymethamphetamine ((1)-MDMA) exact significant medical and social costs in the USA and abroad. However, to date, no medications are approved to treat acute and chronic toxicity from these drugs. Medicines that will help transition patients from the emergency department into longer-term treatment programs that promote healthy behavioral change are also needed. The purpose of the proposed research is to produce and complete pre-clinical tests of a new, chimeric monoclonal antibody antagonist (designated ch- mAb4G9) that will bind (+)-METH, (+)-AMP, and (+)-MDMA. Ch-mAb4G9 selectively and quickly binds these target ligands in the blood, reversing the flux of these drugs into the brain and rendering them inactive without altering the function of any catecholamine receptor, thus providing a unique approach for treating drug abuse. The goal of this project is to successfully complete an investigational new drug application (IND) with the indication being treatment of stimulant overdose. Ch-mAb4G9 could be given in the emergency department to initiate treatment by reducing the acute effects of an overdose. It could then be given as part of a behavioral modification program to block pleasurable, reinforcing stimulant effects. Unlike small molecule antagonists, monoclonal antibody (mAb) therapies should not affect normal CNS activity or systemic homeostasis, and they will not interact with psychoactive medications. Furthermore, their intravenous (iv) administration will result in rapid beneficial effects in an overdose. Ch-mAb4G9 could thus have a broad impact, without excluding other treatment options. In the proposed research, mAb4G9, a high affinity anti-(+)-METH mouse mAb that reduces the effects of iv (+)-METH doses in rats, will be produced as a human/mouse chimeric mAb and tested in rats for safety and pre-clinical efficacy in preparation for Food and Drug Administration (FDA)-approved human trials. A transdisciplinary academic/industry team will accomplish the necessary, integrated Specific Aims: 1) establishing a high-yield master cell bank that secretes ch-mAb4G9 and producing the medication for testing; 2) extensive testing of ch-mAb4G9 for bioequivalence with the mouse form of the mAb; 3) in vitro (human and rat) and in vivo (rat) toxicology testing; and 4) document preparation, quality control, and clinical protocol development necessary for a successful IND application. NIDA funding alone has supported the discoveries and methods development that have brought us to this point. However, this work cannot be reasonably expected to be carried out successfully without GO grant support because these FDA-required studies are expensive, and capital funding for early-stage drug development companies to prepare new drug abuse therapies for human trials is scarce. Nevertheless, this project is ready to be deployed immediately upon funding, and the successful development of this new therapy with FDA validation will leverage the previous work by the investigators to develop the resources needed for a long-term, sustainable program. PUBLIC HEALTH RELEVANCE: We have developed a new medication for treating toxic effects from overdose and long-term use of (+)- methamphetamine, (+)-amphetamine, and (1)methylenedioxymethamphetamine ((1)-MDMA) which has the potential to reduce their devastating behavioral and societal effects, and therefore improve public health. This innovative antibody medication could provide an essential missing component in transitioning the patient from emergency care into long-term programs that promote healthy behavioral changes. This project will produce and perform all testing of a chimeric monoclonal antibody medication necessary to prepare for conducting human clinical trials. | ||
| Project Information | ||||||||||||||||||||||||||
| Project Name or Project/Program Title |
Project Status | Total Federal Amount ARRA Funds Received/Invoiced |
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| CHIMERIC ANTI-METHAMPHETAMINE MONOCLONAL ANTIBODY FOR TREATING STIMULANT TOXICITY | Recipient responsible for this data | Recipient responsible for this data | ||||||||||||||||||||||||
| Number of Jobs | Description of Jobs Created | |||||||||||||||||||||||||
| Recipient responsible for this data | Recipient responsible for this data | |||||||||||||||||||||||||
| Quarterly Activities/Project Description | ||||||||||||||||||||||||||
| Recipient responsible for this data | ||||||||||||||||||||||||||
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| Total Federal Amount of ARRA Expenditure |
Total Federal ARRA Infrastructure Expenditure |
Infrastructure Contact Name | ||||||||||||||||||||||||
| Recipient responsible for this data | Recipient responsible for this data | Recipient responsible for this data | ||||||||||||||||||||||||
| Infrastructure Contact Email | Infrastructure Contact Phone | Infrastructure Contact Phone Ext. | ||||||||||||||||||||||||
| Recipient responsible for this data | Recipient responsible for this data | Recipient responsible for this data | ||||||||||||||||||||||||
| Infrastructure Contact Street Address 1 | Infrastructure Contact Street Address 2 | Infrastructure Contact Street Address 3 | ||||||||||||||||||||||||
| 4301 WEST MARKHAM STREET | Not Available | Recipient responsible for this data | ||||||||||||||||||||||||
| Infrastructure City | Infrastructure State | Infrastructure ZIP Code+4 | ||||||||||||||||||||||||
| LITTLE ROCK | AR | 72205-7101 | ||||||||||||||||||||||||
| Infrastructure Purpose and Rationale | ||||||||||||||||||||||||||
| Recipient responsible for this data | ||||||||||||||||||||||||||
| Primary Place of Performance | ||
| Street Address 1 | Street Address 2 | City |
| 4301 WEST MARKHAM STREET#831 | Recipient responsible for this data | LITTLE ROCK |
| State | Zip Code+4 | Congressional District |
| AR | 72205 | Not Available |
| Country | ||
| US | ||
| Recipient Highly Compensated Officers | |||
| Prime Recipient Indication of Reporting Applicability | # | Officer Name | Officer Compensation |
| Recipient responsible for this data | 1 | Recipient responsible for this data | Recipient responsible for this data |
| 2 | Recipient responsible for this data | Recipient responsible for this data | |
| 3 | Recipient responsible for this data | Recipient responsible for this data | |
| 4 | Recipient responsible for this data | Recipient responsible for this data | |
| 5 | Recipient responsible for this data | Recipient responsible for this data | |
This concludes the current search.
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USE IN THE RECIPIENT REPORT
The information provided by this tool is baseline data that the Recipient should include in the Recipient Report that must be submitted to FederalReporting.gov beginning October 1, 2009. The data from this tool can be cut and pasted directly into the Recipient Report.
