MEDSCHOOL, MED, Research, Translational Medicine Unit (TMU) - About Us

ABOUT US

The USU Translational Medicine Unit (TMU) was founded in the late 1980’s as the Clinical Pharmacology Unit by Dr. Louis Cantilena, MD, PhD. It is a storied unit with major contributions to medical product development and scientific literature. CPU was one of the first units to identify and thoroughly investigate cardiac repolarization injury. This led to landmark publications, as well as bold advocacy that led to relabeling and in some cases withdrawal of potentially unsafe pharmaceuticals.

The CPU conducted a long list of regulated and investigator-initiated clinical trials in the areas of cardiac drug safety, drugs of abuse, antimalarial pharmacology and others over the last 25 years. The studies conducted supported the development of compounds to reduce cravings for drugs of abuse, two recently approved antimalarial drugs developed by the US Army, and cardiac safety studies.

The CPU was renamed the Clinical Research Unit (CRU) in 2010, and continued to conduct outpatient clinical pharmacology research. In 2017, the CRU began to provide clinical trials service support to other investigators at the University with relevant projects.  In 2020, COVID-19 brought support for new studies by the USU Infectious Disease Clinical Research Program.

In 2021, we became the Translational Medicine Unit. The TMU has grown to include a pediatric research team. We currently conduct more than a dozen COVID-19 and non-COVID studies. We continue to provide clinical trial support to other Investigators at the University on a space-available basis.  Moving forward, the TMU aims to conduct 2-4 clinical trials a year of novel products to benefit military medicine and to protect and treat warfighters engaged in Multi-Domain Operating environments.

Previous Research and Publications

The TMU’s portfolio has included studies of

• Multiple cardiotoxins
• Opioid analgesics
• Substances of abuse
• Anti-malarials
• Anti-steatosis products
• Vaccines
• Other drugs and devices.
• Post Concussive and Posttraumatic Stress

TMU Publications:

2015-2020

Livezey J, Twomey P, Morrison M, Cicatelli S, Duncan EH, Hamer M, Lee C, Hutter J, Mills K, DeLuca J, Poon L, Selig D, Vuong C, Sousa J, Oliver T, Bennett J, Moon JE, Sikaffy A, Sedegah M, Tosh D, Kreishman-Deitrick M, Waterman P. An open label study of the safety and efficacy of a single dose of weekly chloroquine and azithromycin administered for malaria prophylaxis in healthy adults challenged with 7G8 chloroquine-resistant Plasmodium falciparum in a controlled human malaria infection model. Malar J. 2020 Sep 16;19(1):336. doi: 10.1186/ s12936-020-03409-z. PMID: 32938444; PMCID:PMC7493140

Vanachayangkul P, Lon C, Spring S, Sok S, Ta-aksorn W, Kodchakorn C, Phann ST, Chann S, Ittiverakul M, Sriwichai S, Buathong N, Kuntawunginn W, So M, Youdaline T, Milner E, Wojnarski M, Lanteri C, Manning J, Prom S, Haigney M, Cantilena L,  Saunders D.  Piperaquine population pharmacokinetics and cardiac safety in Cambodia. Antimicrobial Agents and Chemotherapy, May 2017; 61 (5): e02000-16.

Livezey J, Oliver T, Cantilena L. Prolonged neuropsychiatric symptoms in a military service member exposed to mefloquine. Drug safety-case reports. 2016 Dec;3(1):1-6.

Dart RC, Bronstein AC, Spyker DA, Cantilena LR, Seifert SA, Heard SE, Krenzelok EP. Poisoning in the United States: 2012 emergency medicine report of the National Poison Data System. Annals of emergency medicine. 2015 Apr 1:65(4):416-22.

2010-2014

Manning J, Vanachayangkul P, Lon C, Spring M…Chuor CM, Prom S, Haigney M, Cantilena L, and Saunders D. Randomized, double-blind, placebo-controlled clinical trial of a two-day regimen of dihydroartemisinin-piperaquine for malaria prevention halted for concern of prolonged QTc interval. Antimicrobial Agents and Chemotherapy, 2014, 58(10):6056-67.

Mowry JB, Spyker DA, Cantilena Jr LR, McMillan N, Ford M. 2013 annual report of the American association of poison control centers’ National poison data system (NPDS): 31st annual report. Clinical toxicology. 2014 Dec 1;52(10):1032-283.

Mowry JB, Spyker DA, Cantilena Jr LR, Bailey JE, Ford M. 2012 Annual report of the American association of poison control centers’ national poison data system (NPDS): 30th annual report. Clinical toxicology. 2013 Dec 1;51(10):949-1229.

Miller RS, Li Q, Cantilena LR, Leary KJ, Saviolakis GA, Melendez V, Smith B, Weina PJ. Pharmacokinetic profiles of artesunate following multiple intravenous doses of 2, 4, and 8 mg/kg in healthy volunteers: phase 1b study. Malaria journal. 2012 Dec;11(1):1-0.

Saunders D, Messina J, Darwish M, Xie F, Leary KJ, Cantilena LR. Assessment of the Relative Potency of Fentanyl Buccal Tablet to Intravenous Morphine in Healthy Volunteers Using a Thermally Induced Hyperalgesia Pain Model. Journal of Clinical Pharmacology 2012; 52 (6):
870–879.

Bronstein AC, Spyker DA, Cantilena Jr LR, Rumack BH, Dart RC. 2011 annual report of the American Association of Poison Control Centers’ National Poison data system (NPDS): 29th annual report.

Bronstein AC, Spyker DA, Cantilena LR, Green JL, Rumack BH, Dart RC. 2010 Annual report of the American Association of Poison control centers’ National Poison Data System (NPDS): 28th annual report. Clinical Toxicology. 2011 Dec 1;49(10):910-41.

2005-2009

Li Q, Cantilena LR, Leary KJ, Saviolakis GA, Miller RS, Melendez V, Weina PJ. Pharmacokinetic profiles of artesunate after single intravenous doses at 0.5, 1, 2, 4, and 8 mg/kg in healthy volunteers: a phase I study. The American journal of tropical medicine and hygiene. 2009 Oct 1;81(4):615-21.

Bronstein AC, Spyker DA, Cantilena Jr LR, Green JL, Rumack BH, Heard SE. 2007 Annual report of the American Association of Poison Control Centers' National poison data system (NPDS): 25th annual report. Clinical Toxicology. 2008 Jan 1;46(10):927-1057.

Bronstein AC, Spyker DA, Cantilena Jr LR, Green J, Rumack BH, Heard SE. 2006 Annual Report of the American Association of Poison Control Centers' National Poison Data System (NPDS). Clinical toxicology. 2007 Jan 1;45(8):815-917.

2000-2004

Knudsen JF, Carlsson U, Hammarström P, Sokol GH, Cantilena LR. The cyclooxygenase-2 inhibitor celecoxib is a potent inhibitor of human carbonic anhydrase II. Inflammation. 2004 Oct;28(5):285-90.

Fenichel RR, Malik M, Antzelevitch C, Sanguinetti M, Roden DM, Priori SG, Ruskin JN, Lipicky RJ, Cantilena LR, Independent Academic Task Force. Drug‐induced torsades de pointes and implications for drug development. Journal of cardiovascular electrophysiology. 2004 Apr;15(4):475-95.

1995-1999

Graumlich JF, Ludden TM, Conry-Cantilena C, Cantilena LR, Wang Y, Levine M. Pharmacokinetic model of ascorbic acid in healthy male volunteers during depletion and repletion. Pharmaceutical research. 1997 Sep;14(9):1133-9.

Levine M, Conry-Cantilena C, Wang Y, Welch RW, Washko PW, Dhariwal KR, Park JB, Lazarev A, Graumlich JF, King J, Cantilena LR. Vitamin C pharmacokinetics in healthy volunteers: evidence for a recommended dietary allowance. Proceedings of the National Academy of Sciences. 1996 Apr 16;93(8):3704-9.

Benton RE, Honig PK, Zamani K, Cantilena LR, Woosley RL. Grapefruit juice alters terfenadine pharmacokinetics, resulting in prolongation of repolarization on the electrocardiogram. Clinical Pharmacology & Therapeutics. 1996 Apr;59(4):383-8.

Takimoto CH, Lu ZH, Zhang R, Liang MD, Larson LV, Cantilena LR, Grem JL, Allegra CJ, Diasio RB, Chu E. Severe neurotoxicity following 5-fluorouracil-based chemotherapy in a patient with dihydropyrimidine dehydrogenase deficiency. Clinical cancer research. 1996 Mar 1;2(3):477-81.

1990-1994

Honig PK, Wortham DC, Zamani K, Cantilena LR. Comparison of the effect of the macrolide antibiotics erythromycin, clarithromycin and azithromycin on terfenadine steady-state pharmacokinetics and electrocardiographic parameters. Drug Investigation. 1994 Mar;7(3):148-56.

Honig PK, Wortham DC, Hull R, Zamani K, Smith JE, Cantilena LR. Itraconazole affects single‐dose terfenadine pharmacokinetics and cardiac repolarization pharmacodynamics. The Journal of Clinical Pharmacology. 1993 Dec;33(12):1201-6.

Honig PK, Wortham DC, Zamani K, Conner DP, Mullin JC, Cantilena LR. Terfenadine-ketoconazole interaction: pharmacokinetic and electrocardiographic consequences. Jama. 1993 Mar 24;269(12):1513-8.

Cantilena LR, Smith RP, Frasur S, Kruszyna H, Kruszyna R, Wilcox DE. Nitric oxide hemoglobin in patients receiving nitroglycerin as detected by electron paramagnetic resonance spectroscopy. The Journal of laboratory and clinical medicine. 1992 Dec 1;120(6):902-7.

Honig PK, Woosley RL, Zamani K, Conner DP, Cantilena Jr LR. Changes in the pharmacokinetics and electrocardiographic pharmacodynamics of terfenadine with concomitant administration of erythromycin. Clinical Pharmacology & Therapeutics. 1992 Sep;52(3):231-8.

Cantilena LR, Stukel TA, Greenberg ER, Nann S, Nierenberg DW. Diurnal and seasonal variation of five carotenoids measured in human serum. The American journal of clinical nutrition. 1992 Mar 1;55(3):659-63.

Monahan BP, Ferguson CL, Killeavy ES, Lloyd BK, Troy J, Cantilena LR. Torsades de pointes occurring in association with terfenadine use. Jama. 1990 Dec 5;264(21):2788-90.