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 | 3R42DK063882-06S1 | Recipient responsible for this data |
| Award Recipient Information | ||
| Recipient DUNS Number | Recipient Account Number | Recipient Congressional District |
| 140243572 | Recipient responsible for this data | 18 |
| Award Information | ||
| Funding Agency Code | Awarding Agency Code | Award Date |
| 7529 | 7529 | 01-26-2010 |
| Amount of Award | Sub Account Number for Program Source (TAS) | |
| $ 37,500 | Recipient responsible for this data | |
| Program Source (TAS)* | CFDA Number | |
| 750883 | 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): In this Competing Continuation of our STTR Phase II grant, we propose to build upon the considerable progress made during the previous two funding cycles in our effort to develop a new family of phosphatidylcholine (PC)-associated nonsteroidal anti-inflammatory drugs (NSAIDs). During this period we have continued to develop our lead compounds, ibuprofen-PC and aspirin-PC, in which we chemically associate the NSAIDs with soy PC, and have demonstrated that these formulations have reduced GI toxicity while maintaining or enhancing the drugs therapeutic activity in rodent model systems. Based upon this evidence, and that provided by our Contract Research Organization (Synergos, Inc.) and manufacturer (Cardinal Health), the FDA has issued an IND for the ibuprofen-PC and has approved an accelerated 505(b)(2) regulatory path for bioequivalence, which was supported by human pharmacokinetic data in Phase I/II and III trials on healthy subjects, together with a Phase II trial in which osteoarthritic (OA) patients were placed on either ibuprofen or ibuprofen-PC for a 6 week study period, to provide information on the GI safety and therapeutic activity of the test drugs. As described in the revised application, these clinical studies, that were funded by the small business and a R03 grant from NIH, demonstrated that ibuprofen-PC had similar bioavailability and therapeutic activity to ibuprofen, but was significantly less injurious to the gastroduodenal mucosa of OA patients most susceptible to NSAID-induced GI side effects, those who were > 55 years of age. In this revised grant application, we propose to continue this promising line of investigation, and perform a 12 week endoscopic trial in OA patients, which should provide confirmatory evidence on the GI safety and anti- inflammatory/analgesic activity of ibuprofen-PC. We also propose a series of laboratory experiments in which we will be working closely with our project team at Cardinal Health to optimize the current ibuprofen-PC formulation, so that it can meet FDA's manufacturing guidelines, and to further develop a new method of preparing PC-NSAIDs, which appears to result in obtaining a purified ibuprofen-PC complex, as an oil. This purified ibuprofen-PC possesses superior GI safety and therapeutic activity in rodent model systems and we also propose in this grant to evaluate its bioavailability in healthy human subjects under a modified IND, to obtain accelerated regulatory approval for this product. We also propose to file an IND for aspirin-PC and propose pharmacokinetic studies in healthy subjects to determine if it is bioequivalent to aspirin, which would allow us to pursue a 505(b)(2) regulatory pathway. Lastly, we propose a series of preclinical and pilot clinical studies to confirm preliminary evidence that aspirin-PC is far less toxic than aspirin when co-administered to animals with Celebrex. The successful completion of the above studies will allow us to file an NDA on one or both formulations of ibuprofen-PC and aspirin-PC, initially for bioequivalence, and ultimately for enhanced GI safety and therapeutic activity. Accomplishing these milestones should place us in a very competitive position to attract a corporate partner to facilitate the commercialization of both ibuprofen- PC and aspirin-PC, and perhaps the entire PC-NSAID franchise, making this novel class of drugs available to the public, that is in great need for a safe and effective NSAID. Nonsteroidal anti-inflammatory drugs (NSAIDs) are highly consumed by Americans, especially older members of our population suffering from osteoarthritis (OA), due to their potent anti- inflammatory and analgesic actions. However, the use of NSAIDs is limited by their serious side effect of inducing gastrointestinal (GI) ulceration and bleeding in susceptible individuals, being responsible for 103,000 hospitalizations and 16,500 deaths a year. The technology to be developed in this grant proposal relates to prevention of NSAID-induced GI ulceration and bleeding by chemical association of NSAIDs with the surface-active lipid, phosphatidylcholine (PC). Development of PC-associated NSAIDs will provide drugs that can be more safely used by millions with OA for relief of pain and inflammation, and for other potential uses like prevention of cancer and Alzheimer's disease. | ||
| Project Information | ||||||||||||||||||||||||||
| Project Name or Project/Program Title |
Project Status | Total Federal Amount ARRA Funds Received/Invoiced |
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| GASTROINTESTINAL SAFETY AND THERAPEUTICS OF OIL-BASED PHOSPHATIDYLCHOLINE-NSAIDS | 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 | ||||||||||||||||||||||||
| 8030 EL RIO | Not Available | Recipient responsible for this data | ||||||||||||||||||||||||
| Infrastructure City | Infrastructure State | Infrastructure ZIP Code+4 | ||||||||||||||||||||||||
| HOUSTON | TX | 77054 | ||||||||||||||||||||||||
| Infrastructure Purpose and Rationale | ||||||||||||||||||||||||||
| Recipient responsible for this data | ||||||||||||||||||||||||||
| Primary Place of Performance | ||
| Street Address 1 | Street Address 2 | City |
| 8285 EL RIOSUITE 130 | Recipient responsible for this data | HOUSTON |
| State | Zip Code+4 | Congressional District |
| TX | 77054 | 9 |
| 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 | |
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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.
