? The purpose of this proposal is for Thromgen, Inc. to transition its preclinical agent, Thrombostatin(tm), into human clinical trials. Thromgen, Inc. has created an agent that is a low affinity direct thrombin inhibitor and a higher affinity binder to the thrombin activation site on both human protease receptor 1 (PAR1) and 4 (PAR4) to prevent thrombin cleavage of these substrates. Both small and large animal studies demonstrate that this agent delays the time to thrombosis in both coronary and carotid artery thrombosis models in both the mouse and dog. Thromgen, Inc. now seeks funding to support toxicology studies for its best agent, Thrombostatin(tm), for the preparation of an Investigator New Drug (IND) application to the FDA.
The specific aims are two-fold: ? Specific Aim #1: Toxicology investigations will be performed in rodent and nonrodent animal species for the preparation of a Thrombostatin(tm) IND application to the FDA for a single intravenous administration.
Specific Aim #2 : Analytical studies and genotoxicity investigations on the agent will be performed for FDA requirements for an IND application. The purpose of this program is multifaceted. First, the safety of the current Thrombostatin(tm) for human use will be determined. Second, the preparation of an IND application for its human use for one indication will be achieved. Thrombostatin(tm) has the opportunity to be a first-in-its-class thrombin receptor activation antagonist. ? ?

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
2R44HL055907-04
Application #
6885090
Study Section
Special Emphasis Panel (ZRG1-SBTS (10))
Program Officer
Ganguly, Pankaj
Project Start
1996-04-01
Project End
2006-11-30
Budget Start
2005-06-01
Budget End
2006-05-31
Support Year
4
Fiscal Year
2005
Total Cost
$877,297
Indirect Cost
Name
Thromgen, Inc.
Department
Type
DUNS #
943846253
City
Ann Arbor
State
MI
Country
United States
Zip Code
48107
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