Administrative Supplement to restore fee funds

Project Summary Traumatic brain injuryTBIcauses detrimental behavioral dysfunctions and brain neurodegeneration butunfortunatelythere currently is no effective pharmaceutical TBI treatmentThe underlying PhaseSTTR grant is to develop a new class of TBI drugs that inhibit the protease cathepsin BGenetically deleting the cathepsin B gene in mice results in substantial behavioral and pathology improvements in the controlled cortical impactCCITBI model relative to animals expressing that proteaseMoreoveradministering tool compoundswhich inhibit cathepsin Bcalled Ed and Ecto wild type mice following CCI also produce similar improvementsCathepsin B knockout mice are healthy and prior studies in pediatric patients found Ed to be safeThusthere is reason to believe that cathepsin B inhibitor compounds may be effective and safe for treating TBIThe underlying grant will determine pharmacological parameters and efficacy for the tool compounds in the CCI mouse model The GranteeAmerican Life Science Pharmaceuticalsdeveloped deuterium derivatives of the tool compounds and obtained patents protecting those derivatives in the United States and EuropeThose deuterium derivatives will be subsequently developed as TBI therapeuticsThe instant application is for an Administrative Supplement to restore funds that were cut from the Fee category of the underlying grant due to insufficient funds at the time the award was madeThe Fee category allows for unrestricted use of fundsThe Supplemental Award will be used to pay for on going patent costs in the United States and EuropeThat expenditure is absolutely essential because without those patentsthe TBI therapeutics cannot be commercially developed Project Narrative There currently is no effective pharmaceutical treatment to reduce the disabilitiesneurodegeneration and death caused by traumatic brain injuryTBIThe underlying STTR grant will develop promising new TBI therapeuticsThe instant Administrative Supplement will be used to fund on going patent costs for those potential therapeuticsPatent exclusivity is absolutely essential to attract the investment needed for commercial development of these compoundsThusthe Supplement is essential to the mission of the project