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4 results on '"Matthew M. Heeney"'

1. Double-blind, randomized, multicenter phase 2 study of SC411 in children with sickle cell disease (SCOT trial)

Author

Ahmed A. Daak, Carlton D. Dampier, Beng Fuh, Julie Kanter, Ofelia A. Alvarez, L. Vandy Black, Melissa A. McNaull, Michael U. Callaghan, Alex George, Lynne Neumayr, Lee M. Hilliard, Fredrick Sancilio, Adrian L. Rabinowicz, and Matthew M. Heeney

Subjects
Specialties of internal medicine, RC581-951
Abstract

Abstract: Blood cell membranes in sickle cell disease (SCD) have low docosahexaenoic acid (DHA). DHA treatment reduces sickle cell crisis (SCC) rate and ameliorates the inflammation, oxidative stress, and hypercoagulable state of SCD. SC411 is a novel DHA ethyl ester formulation with a proprietary delivery platform (Advanced Lipid Technology) that enhances DHA bioavailability. The SCOT trial investigated the effect of 3 different doses of SC411 on clinical and biochemical endpoints in 67 children with SCD (5-17 years old). Seventy-six percent of subjects were also receiving hydroxyurea. After 4 weeks of treatment with SC411 at 20, 36, and 60 mg DHA/kg per day or placebo a statistically significant (P < .001) mean percentage increase of blood cell membrane DHA and eicosapentaenoic acid was seen vs baseline: 109.0% (confidence interval [CI], 46.7-171.3), 163.8% (CI, 108.3-219.2), 170.8% (CI, 90.2-251.4), and 28.6% (CI, 250.1 to 107.3), respectively. After 8 weeks of treatment, statistically significant changes vs placebo were also observed in D-dimer (P = .025) and soluble E-selectin (P = .0219) in subjects exposed to 36 mg/kg. A significant increase in hemoglobin was observed against placebo in subjects receiving 20 mg DHA/kg per day (P = .039). SC411 significantly reduced electronic diary recorded SCC, analgesic use at home, and days absent from school because of sickle cell pain. The lower rate of clinical SCC observed in the pooled active groups vs placebo did not reach statistical significance (rate ratio, 0.47; 95% CI, 0.20-1.11; P = .07). All tested doses were safe and well tolerated. This trial was registered at www.clinicaltrials.gov as #NCT02973360.

Published
2018
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2. Randomized phase 2 trial of regadenoson for treatment of acute vaso-occlusive crises in sickle cell disease

Author

Joshua J. Field, Elaine Majerus, Victor R. Gordeuk, Michel Gowhari, Carolyn Hoppe, Matthew M. Heeney, Maureen Achebe, Alex George, Hillary Chu, Brian Sheehan, Maneka Puligandla, Donna Neuberg, Gene Lin, Joel Linden, and David G. Nathan

Subjects
Specialties of internal medicine, RC581-951
Abstract

Abstract: Adenosine A2A receptor (A2AR) agonists have been shown to decrease tissue inflammation induced by hypoxia/reoxygenation in mice with sickle cell disease (SCD). The key mediator of the A2AR agonist's anti-inflammatory effects is a minor lymphocyte subset, invariant natural killer T (iNKT) cells. We tested the hypothesis that administration of an A2AR agonist in patients with SCD would decrease iNKT cell activation and dampen the severity of vaso-occlusive (VO) crises. In a phase 2, randomized, placebo-controlled trial, we administered a 48-hour infusion of the A2AR agonist regadenoson (1.44 μg/kg per hour) to patients with SCD during VO crises to produce a plasma concentration of ∼5 nM, a concentration known from prior studies to suppress iNKT cell activation in SCD. The primary outcome measure was a >30% reduction in the percentage of activated iNKT cells. Ninety-two patients with SCD were randomized to receive a 48-hour infusion of regadenoson or placebo, in addition to standard-of-care treatment, during hospital admission for a VO crisis and had analyzable iNKT cell samples. The proportion of subjects who demonstrated a reduction of >30% in activated iNKT cells was not significantly different between the regadenoson and placebo arms (43% vs 23%; P = .07). There were also no differences between regadenoson and placebo groups in length of hospital stay, mean total opioid use, or pain scores. These data demonstrate that a low-dose infusion of regadenoson intended to reduce the activity of iNKT cells is not sufficient to produce a statistically significant reduction in such activation or in measures of clinical efficacy. This trial was registered at www.clinicaltrials.gov as #NCT01788631.

Published
2017
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3. Contributors

Author

David Adams, Sherri L. Adams, Chhavi Agarwal, Elizabeth R. Alpern, Armand H. Matheny Antommaria, Megan H. Bair-Merritt, Lourival Baptista-Neto, Jill Baren, Carl R. Baum, Eric D. Baum, Pamela J. Beasley, Suzanne Beno, Laurie A. Bernard, Stacey E. Bernstein, Chad K. Brands, Laura K. Brennan, Marisa B. Brett-Fleegler, Manish J. Butte, Julie Story Byerley, Diane P. Calello, Deirdre Caplin, Rebecca G. Carlisle, Douglas W. Carlson, Jean Marie Carroll, Mary Wu Chang, Grace M. Cheng, Aaron S. Chidekel, Denesh K. Chitkara, Bill Chiu, Christine S. Cho, Jeanne S. Chow, Bartley G. Cilento, Susan E. Coffin, Bernard A. Cohen, Kristina A. Cole, Patrick H. Conway, Maura Cooper, Timothy Cornell, Kate M. Cronan, Catherine Cross, Bari B. Cunningham, Melody J. Cunningham, Jennifer A. Daru, Ian J. Davis, Matthew A. Deardorff, Barbara Degar, Michael DelVecchio, David Ray DeMaso, Marissa de Ungria, Stephanie B. Dewar, Craig C. DeWolfe, Martha Dimmers, James G.H. Dinulos, Ed Donovan, Kenneth J. Dooley, Emmanuel Doyne, Christine N. Duncan, Marie Egan, Lawrence F. Eichenfield, Moussa El-hallak, Scott A. Elisofon, Stephen C. Eppes, Michele Burns Ewald, Mirna M. Farah, Chris Feudtner, Andrew M. Fine, Susan Hetzel Frangiskakis, Gary Frank, Eric Frehm, Nicole R. Frei, Ilona J. Frieden, Eron Y. Friedlaender, Jeremy Friedman, Robert Hugh Fryer, David R. Fulton, Paul J. Galardy, Mirabai Galashan, Mary Pat Gallagher, Beth D. Gamulka, Rupali Gandhi, Mary B. Garza, Maria C. Garzon, Robert L. Geggel, Michael H. Gewitz, Timothy Gibson, Amy E. Gilliam, Katherine B. Ginnis, Amy Goldberg, Anna M. Golja, Melissa J. Gregory, April A. Harper, Mary Catherine Harris, Natalie Hayes, Matthew M. Heeney, Diana M. Heinzman, Meredith Lee Heltzer, Keith D. Herzog, Malinda Ann Hill, Jessica L. Hills, Alejandro Hoberman, K. Sarah Hoehn, Amber M. Hoffman, Robert J. Hoffman, Amy P. Holst, Charles J. Homer, Paul J. Honig, Patricia M. Hopkins, Mark D. Hormann, B. David Horn, Michael S. Isakoff, Katherine A. Janeway, Katherine Ahn Jin, Maureen M. Jonas, Tammy Kang, Krista Keilty, Ron Keren, Anupam Kharbanda, Marin Kiesau, Caroline C. Kim, Jason Y. Kim, Juliann Lipps Kim, Nicola Klein, Paul K. Kleinman, Joel B. Korin, Uma Kotagal, Lisa K. Kresnicka, Rana N. Kronfol, Cynthia L. Kuelbs, Subra Kugathasan, Amethyst C. Kurbegov, Christopher P. Landrigan, Miriam Laufer, Christine Lauren, Daniel J. Lebovitz, Natasha Leibel, Lucinda P. Leung, Leonard J. Levine, Jason A. Levy, Phyllis A. Lewis, Marilyn G. Liang, Daniel J. Licht, Carolyn M. Long, Jeffrey P. Louie, Barry A. Love, Patricia V. Lowery, Ian B. MacLusky, Katarzyna Madejczyk, Mary Beth Madonna, Sanjay Mahant, Paul E. Manicone, Jennifer Maniscalco, Keith Mann, Rebekah Mannix, Jonathan M. Mansbach, Peter Mattei, Oscar H. Mayer, Sarah C. McBride, Kevin D. McBryde, Michele R. McKee, William McNett, Sanford M. Melzer, Talene A. Metjian, Denise W. Metry, Stephen E. Muething, Emily E. Milliken, Laura J. Mirkinson, Manoj K. Mittal, Angela C. Mix, Debra Monzack, Kimberly D. Morel, Douglas E. Moses, Eugene M. Mowad, Elizabeth A. Mullen, John B. Mulliken, Sharon Muret-Wagstaff, Nancy Murphy, Frances M. Nadel, Joshua Nagler, James A. Nard, Mark I. Neuman, Jason G. Newland, Alice W. Newton, Peter F. Nichol, Lise E. Nigrovic, Richard J. Noel, Sharon E. Oberfield, Maureen M. O'Brien, Karen J. O'Connell, Kevin C. Osterhoudt, Mary Ottolini, Raj Padman, Horacio M. Padua, Alka Patel, Susmita Pati, Jack M. Percelay, Jeannette M. Perez-Rossello, Kieran J. Phelan, Annapurna Poduri, J. Rainer Poley, Jill C. Posner, Sampath Prahalad, Howard B. Pride, Daniel Rauch, David J. Rawat, Scott Reeves, Daniel H. Reirden, Brandie J. Roberts, Jack Rodgers, José R. Romero, Paul Rosen, David M. Rubin, Esther Maria Sampayo, Lisa Samson-Fang, Gina Santucci, Julie V. Schaffer, Karen E. Schetzina, Sandra Schwab, Donald F. Schwarz, Jordan Scott, Steven M. Selbst, Kara N. Shah, Samir S. Shah, Nader Shaikh, Michael W. Shannon, Adhi N. Sharma, George K. Siberry, Karen Smith, Michael J. Smith, Michael J.G. Somers, Neal Sondheimer, Steven J. Spalding, Philip R. Spandorfer, Jonathan M. Spergel, Jeffrey L. Sperring, David A. Spiegel, Rajendu Srivastava, Keith H. St. John, Michael C. Stephens, Christopher C. Stewart, Bryan L. Stone, Erin R. Stucky, Eric R. Sundel, Robert Sundel, Suzanne Swanson, Lesli Taylor, E. Douglas Thompson, Avram Z. Traum, Harsh K. Trivedi, Bryan D. Upham, Andrea M. Vandeven, Brigid L. Vaughan, Charles P. Venditti, Venus M. Villalva, Robert N. Vincent, Samuel Volchenboum, Michael T. Vossmeyer, Robert M. Wachter, Daniel J. Weiner, Michael Weinstein, Elizabeth A. Wharff, Stephen D. Wilson, Jerry A. Winkelstein, Heidi Wolf, George A. Woodward, Albert C. Yan, Elaine H. Zackai, Andrea L. Zaenglein, Theoklis E. Zaoutis, and David Zipes

Published
2007
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4. Sickle Cell Disease

Author

Matthew M. Heeney

Subjects
medicine.anatomical_structure, business.industry, Cell, Immunology, medicine, Disease, business
Published
2007
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