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Page 1
Comprehensive Nonclinical Safety Assessment of Nirmatrelvir Supporting Timely Development of the SARS-COV-2 Antiviral Therapeutic, Paxlovid™.
Sathish JG, Bhatt S, DaSilva JK, Flynn D, Jenkinson S, Kalgutkar AS, Liu M, Manickam B, Pinkstaff J, Reagan WJ, Shirai N, Shoieb AM, Sirivelu M, Vispute S, Vitsky A, Walters K, Wisialowski TA, Updyke LW. Sathish JG, et al. Among authors: pinkstaff j. Int J Toxicol. 2022 Aug;41(4):276-290. doi: 10.1177/10915818221095489. Epub 2022 May 21. Int J Toxicol. 2022. PMID: 35603517 Free PMC article.
Translation of nonclinical to clinical safety findings for 27 biotherapeutics.
Leach MW, Rana P, Hu W, Mittapalli RK, Pinkstaff J, Potter D, Qiu XM, Ramaiah L, Rohde C, Xia F, Khan KN. Leach MW, et al. Among authors: pinkstaff j. Toxicol Appl Pharmacol. 2024 Mar;484:116854. doi: 10.1016/j.taap.2024.116854. Epub 2024 Feb 10. Toxicol Appl Pharmacol. 2024. PMID: 38346540 Free article.
KCNQ1 suppression-replacement gene therapy in transgenic rabbits with type 1 long QT syndrome.
Bains S, Giammarino L, Nimani S, Alerni N, Tester DJ, Kim CSJ, Christoforou N, Louradour J, Horváth A, Beslac O, Barbieri M, Matas L, Hof TS, Lopez R, Perez-Feliz S, Parodi C, Garcia Casalta LG, Jurgensen J, Barry MA, Bego M, Keyes L, Owens J, Pinkstaff J, Koren G, Zehender M, Brunner M, Casoni D, Praz F, Haeberlin A, Brooks G, Ackerman MJ, Odening KE. Bains S, et al. Among authors: pinkstaff j. Eur Heart J. 2024 Sep 29;45(36):3751-3763. doi: 10.1093/eurheartj/ehae476. Eur Heart J. 2024. PMID: 39115049 Free PMC article.
Safety, pharmacokinetics and CNS distribution of tralesinidase alfa administered via intracerebroventricular infusion to juvenile cynomolgus monkeys.
Pinkstaff J, McCullagh E, Grover A, Melton AC, Cherukuri A, Wait JC, Nguyen A, Butt MT, Trombley JL, Reed RP, Adams EL, Boyd RB, Chandra S, Henshaw J, O'Neill CA, Zanelli E, Kovalchin J. Pinkstaff J, et al. Toxicol Rep. 2023 Mar 1;10:357-366. doi: 10.1016/j.toxrep.2023.02.014. eCollection 2023. Toxicol Rep. 2023. PMID: 36923444 Free PMC article.
Tralesinidase Alfa Enzyme Replacement Therapy Prevents Disease Manifestations in a Canine Model of Mucopolysaccharidosis Type IIIB.
Ellinwood NM, Valentine BN, Hess AS, Jens JK, Snella EM, Jamil M, Hostetter SJ, Jeffery ND, Smith JD, Millman ST, Parsons RL, Butt MT, Chandra S, Egeland MT, Assis AB, Nelvagal HR, Cooper JD, Nestrasil I, Mueller BA, Labounek R, Paulson A, Prill H, Liu XY, Zhou H, Lawrence R, Crawford BE, Grover A, Cherala G, Melton AC, Cherukuri A, Vuillemenot BR, Wait JCM, O'Neill CA, Pinkstaff J, Kovalchin J, Zanelli E, McCullagh E. Ellinwood NM, et al. Among authors: pinkstaff j. J Pharmacol Exp Ther. 2022 Sep;382(3):277-286. doi: 10.1124/jpet.122.001119. Epub 2022 Jun 18. J Pharmacol Exp Ther. 2022. PMID: 35717448 Free PMC article.
Translational studies of intravenous and intracerebroventricular routes of administration for CNS cellular biodistribution for BMN 250, an enzyme replacement therapy for the treatment of Sanfilippo type B.
Grover A, Crippen-Harmon D, Nave L, Vincelette J, Wait JCM, Melton AC, Lawrence R, Brown JR, Webster KA, Yip BK, Baridon B, Vitelli C, Rigney S, Christianson TM, Tiger PMN, Lo MJ, Holtzinger J, Shaywitz AJ, Crawford BE, Fitzpatrick PA, LeBowitz JH, Bullens S, Aoyagi-Scharber M, Bunting S, O'Neill CA, Pinkstaff J, Bagri A. Grover A, et al. Among authors: pinkstaff j. Drug Deliv Transl Res. 2020 Apr;10(2):425-439. doi: 10.1007/s13346-019-00683-6. Drug Deliv Transl Res. 2020. PMID: 31942701 Free PMC article.
Recruiting cytotoxic T cells to folate-receptor-positive cancer cells.
Kularatne SA, Deshmukh V, Gymnopoulos M, Biroc SL, Xia J, Srinagesh S, Sun Y, Zou N, Shimazu M, Pinkstaff J, Ensari S, Knudsen N, Manibusan A, Axup J, Kim C, Smider V, Javahishvili T, Schultz PG. Kularatne SA, et al. Among authors: pinkstaff j. Angew Chem Int Ed Engl. 2013 Nov 11;52(46):12101-12104. doi: 10.1002/anie.201306866. Epub 2013 Sep 25. Angew Chem Int Ed Engl. 2013. PMID: 24573789 Free PMC article.
23 results