Moss RB, Schaberg A, Deans C, Tian W, Smiley L, Herje N, Durham T, Accurso FJ. Denufosol improved lung function in adolescent CF patients. Poster and Powerpoint presentation at the 33rd European Cystic Fibrosis Conference. 2010 June 16-19; Valencia, Spain. Poster in PDF Presentation in PDF
Accurso FJ, Tian W, Schaberg A, Navratil T, Howenstine MS, Liou TG. Potential of denufosol as an early intervention in CF lung disease: efficacy in patients with minimal pharmacotherapy in a U.S. phase 3 clinical trial. Poster presented at the 33rd European Cystic Fibrosis Conference. 2010 June 16-19; Valencia, Spain. Poster in PDF
Navratil T, Schaberg A, Johnson F, Durham T, Ren CL, Ratjen F, Moss RB, Accurso FJ. Aerosol and pharmacokinetic properties of denufosol support its use for early intervention in CF lung disease. Poster presented at the 33rd European Cystic Fibrosis Conference. 2010 June 16-19; Valencia, Spain. Poster in PDF
Durham T, Navratil T, Schaberg A, Deans C, Tian W, Smiley L, Herje N, Accurso FJ. Analysis of polypharmacy in patients with mild cystic fibrosis lung disease assigned to placebo in phase 3 clinical trial of denufosol. Poster presented at the 33rd European Cystic Fibrosis Conference. 2010 June 16-19; Valencia, Spain. Poster in PDF
Boyer J, Durham T, Barnes M, Navratil T, Schaberg A. Denufosol tetrasodium, a P2Y2 receptor agonist for the treatment of cystic fibrosis. Powerpoint presentation at the Purines 2010 Conference. 2010 May 30-Jun 2; Tarragona, Spain. Presentation in PDF
Navratil T, Evans C, Schaberg A, Johnson F, Durham T, Smiley L, Herje N, Burke B, Ren CL, Ratjen F, Moss RB, Accurso FJ. Denufosol tetrasodium – an investigational inhaled therapy with aerosol and pharmacokinetic properties potentially suitable for early intervention in CF lung disease. Poster and Powerpoint presentation at the American Thoracic Society International Conference. 2010 May 14-19; New Orleans, Louisiana, USA. Poster in PDF Presentation in PDF
Durham T, Navratil T, Schaberg A, Deans C, Smiley L, Herje N, Retsch-Bogart G, Accurso FJ. Concomitant medication use in patients with mild cystic fibrosis lung disease assigned to placebo in a phase 3 clinical trial of denufosol (Study 08-108/TIGER-1). Poster presented at the American Thoracic Society International Conference. 2010 May 14-19; New Orleans, Louisiana, USA. Poster in PDF
Cowlen MS, Verhoeven RS. Chronic inhalation of denufosol tetrasodium aerosol is non-inflammatory in rodent and canine respiratory tract tissues. Poster presented at the American Thoracic Society International Conference. 2010 May 14-19; New Orleans, Louisiana, USA. Poster in PDF
Navratil T, Schaberg A, Tian W, Durham T, Evans C, Lindroos C, Barrus S, Mathews D, Barnes M, Ratjen FA, Moss RB, Accurso FJ. Potential of Denufosol as an Early Intervention Therapy for CF Lung Disease. FASEB J. 2010, 24: 31.9 Presentation in PDF
Verhoeven R, Crean C, Cowlen M. 2-Year inhalation carcinogenicity study of nebulized denufosol tetrasodium in Sprague-Dawley rats. Poster presented at the 49th Annual Society of Toxicology Meeting. 2010 Mar 7-11; Salt Lake City, Utah. Poster in PDF
Navratil T, Schaberg A, Mathews D, Deans C, Durham T, Accurso FJ. Pharmacological treatment of CF: Lessons learned from a phase 3 clinical trial. Poster presented at the 23rd Annual North American Cystic Fibrosis Conference. 2009 Oct 15-17; Minneapolis, Minnesota. Poster in PDF
Mospan AR, Durham TA, Schaberg AE, Accurso FJ. Effects of denufosol on sinusitis-related complaints in a phase 3 trial in cystic fibrosis patients. Poster presented at the European Cystic Fibrosis Society (ECFS) Annual Conference. 2009 Jun 10-13; Brest, France. Poster in PDF
Accurso FJ, Durham TA, Schaberg AE. Relationship between pulmonary exacerbations and lung function decline in a six month placebo-controlled trial of denufosol. Poster presented at the European Cystic Fibrosis Society (ECFS) Annual Conference. 2009 Jun 10-13; Brest, France. Poster in PDF
Moss RB, Anbar RD, Wilmot RW, Barnes M, Schaberg AE, Durham TA, Accurso FJ. Phase 3 study of denufosol tetrasodium for the treatment of cystic fibrosis. Poster presented at the American Thoracic Society (ATS ) 2009 International Conference . 2009 May 15-20; San Diego, California, USA. Poster in PDF
Accurso F. A Phase 3 study of denufosol for cystic fibrosis: TIGER-1 results. Powerpoint presentation at the 22nd Annual North American Cystic Fibrosis Conference (NACFC). 2008 Oct 23-25; Orlando, Florida, USA. Presentation in PDF
Crean C, Godin SJ, Cowlen M, Kellerman D. Pharmacokinetics of Denufosol: Results from preclinical studies. Poster presented at the 22nd Annual North American Cystic Fibrosis Conference (NACFC). 2008 Oct 23-25; Orlando, Florida, USA. Poster in PDF
Kellerman D, Rossi Mospan A, Engels J, Schaberg A, Gorden J, Smiley L. Denufosol: A review of studies with inhaled P2Y2 agonists that led to Phase 3. Pulm Pharmacol Ther. 2008 Aug; 21(4): 600-607.
Goss CH, McKone EF, Mathews D, Kerr D, Wanger JS, Millard SP, Cystic Fibrosis Therapeutics Development Network. Experience using centralized spirometry in the Phase 2 randomized, placebo-controlled, double-blind trial of denufosol in patients with mild to moderate cystic fibrosis. J Cyst Fibros. 2008 Mar; 7(2):147-153.
LaVange L, Engels J, Accurso FJ. Analyzing percent change in cystic fibrosis clinical trials. Poster presented at The 21st Annual North American Cystic Fibrosis Conference. 2007 October 3-6; Anaheim, California, USA. Poster in PDF
Mathews D, Schaberg A, Brandi V, Engels J, Gorden J, Deterding R. Pediatric experience from three integrated Phase 2 studies of denufosol tetrasodium inhalation solution. Poster presented at The 21st Annual North American Cystic Fibrosis Conference. 2007 October 3-6; Anaheim, California, USA. Poster in PDF
Friedman JY, Hardy C, Dewitt EM, Schulman KA, Reed SD. Patterns of antibiotic use for patients with mild cystic fibrosis. Poster presented at The 21st Annual North American Cystic Fibrosis Conference. 2007 October 3-6; Anaheim, California, USA. Poster in PDF
Thelin W, Lazarowski E, Boyer JL, Boucher R. Denufosol is a stable and potent inducer of airway secretion. Poster presented at The 21st Annual North American Cystic Fibrosis Conference. 2007 October 3-6; Anaheim, California, USA. Poster in PDF
Deterding RR, Lavange LM, Engels JM, Mathews DW, Coquillette SJ, Brody AS, Millard SP, Ramsey BW; for the Cystic Fibrosis Therapeutics Development Network and the Inspire 08-103 Working Group. Phase 2 randomized safety and efficacy trial of nebulized denufosol tetrasodium in cystic fibrosis. Am J Respir Crit Care Med. 2007 August 15; 176(4):362-364
Kellerman D, Warren S, Rossi A, Taylor G, Smiley L. Deposition and pharmacokinetic studies with inhaled P2Y2 agonists - Evidence of high lung delivery and minimal systemic exposure. Poster presented at the 30th European Cystic Fibrosis Society (ECFS) Conference. 2007 June 13-16; Belek, Turkey. Poster in PDF
Rossi A, Brandi V, Engels J, Gorden J, Schaberg A, Smiley L. Reactive airway disease and cystic fibrosis: A retrospective analysis of the safety and tolerability with denufosol inhalation solution. Poster presented at the 30th European Cystic Fibrosis Society (ECFS) Conference. 2007 June 13-16; Belek, Turkey. Poster in PDF
Cowlen M, Crean C, Poulin D, Ching S, Peterson W, Anderson S. 52-Week inhalation toxicology study of nebulized denufosol tetrasodium in Beagle dogs. Poster presented at the Society of Toxicology (SOT) 46th Annual Meeting. 2007 March 25-29; Charlotte, North Carolina, USA. Poster in PDF
Anderson S, Crean C, Poulin D, Ching S, Peterson W, Cowlen M. 26-Week inhalation toxicology study of nebulized denufosol tetrasodium in Sprague Dawley rats. Poster presented at the Society of Toxicology (SOT) 46th Annual Meeting. 2007 March 25-29; Charlotte, North Carolina, USA. Poster in PDF
Deterding R, Milla C, Barnes M, Engels J, Koenig J, Williams C, Gorden J, Mathews D, Smiley L. Safety and tolerability of denufosol inhalation solution: results of a 28-day Phase 2 study in 5-7 year old patients with CF. Poster presented at the 2006 North American Cystic Fibrosis Conference. 2006 November 2-5; Denver, Colorado, USA. Poster in PDF
Smiley L, Rossi A, Mathews D, Engels J, Schaberg A, Kellerman D, Shaffer C, Deterding R. Denufosol tetrasodium inhalation solution: results from two Phase 2 trials in CF patients with mild to moderate lung disease. Powerpoint presentation by Dr. Lynn Smiley and Poster presented at the 29th European Cystic Fibrosis Conference. 2006 June 15-18; Copenhagen, Denmark. Presentation in PDF Poster in PDF
Evans R, Bogden ME, Tservistas M, Braun A, Seeman S, Keller M. Comparison of the rates of drug delivery and the relative efficiencies of emitted and respirable dose for two different nebulizers yielding qualitatively similar aerosols. Poster presented at the Drug Delivery to the Lungs 16 Meeting. 2005 December 7-9; Edinburgh, Scotland.
Evans R, Ellis Bogden M, Tservistas M, Seeman S, Keller M. Optimization of aerosol characteristics of the eFLOW® electronic nebulizer for pulmonary delivery of a P2Y2 agonist. Poster presented at the 19th Annual North American Cystic Fibrosis Conference. 2005 October 20-23; Baltimore, Maryland, USA. Poster in PDF
Mathews D, Schaberg A, Kellerman D, LaVange L, Engels J, Shaffer C. INS37217 (denufosol tetrasodium) inhalation solution: Phase 1 & 2 clinical experience. Presentation and poster presented at the 28th European Cystic Fibrosis Conference. 2005 June 23-25; Crete, Greece. Poster in PDF
LaVange L,Engels J, Knowles M, Deterding R, Mathews D, Shaffer C. Safety and efficacy of INS37217 inhalation solution in patient subgroups: Results of a Phase 2 multicentre trial. Presentation and poster presented at the 28th European Cystic Fibrosis Conference. 2005 June 23-25; Crete, Greece. Poster in PDF
LaVange LM, Durham TA, Koch GG. Randomization-based nonparametric methods for the analysis of multicentre trials. Stat Methods Med Res. 2005 Jun;14(3): 281-301.
Deterding R, Retsch-Bogart G, Milgram L, Gibson R, Daines C, Zeitlin PL, Milla C, Marshall B, Lavange L, Engels J, Mathews D, Gorden J, Schaberg A, Williams J, Ramsey B. Safety and tolerability of denufosol tetrasodium inhalation solution, a novel P2Y2 receptor agonist: Results of a Phase 1/Phase 2 multicenter study in mild to moderate cystic fibrosis. Pediatr Pulmonol. 2005 Apr;39(4):339-348.
Kellerman DJ, Mills-Wilson M, Johnson C. Pharmacokinetics of INS37217 after inhaled and intravenous administration in healthy volunteers. Poster presentation at the 2004 North American Cystic Fibrosis Conference. 2004 October 14-17; St. Louis, Missouri, USA. Poster in PDF
Goss CH, Mathews D, Kerr D, Wanger JS, Millard SP. Experience using centralized spirometry in the Phase 2 randomized placebo controlled double blind trial of INS37217 inhalation solution in patients with mild CF. Powerpoint and poster presentation at the 2004 North American Cystic Fibrosis Conference. 2004 October 14-17; St. Louis, Missouri, USA. Poster in PDF
Brody AS, Robinson TE, Knowles MR, Goris ML, LaVange LM, Engels JM. High resolution CT in an intervention study in cystic fibrosis. Powerpoint and poster presentation at the 2004 North American Cystic Fibrosis Conference. 2004 October 14-17; St. Louis, Missouri, USA. Poster in PDF
Deterding R, LaVange L, Mathews D, Engels J, Gorden J, Shaffer C, Coquillette S, Ramsey B. Safety and efficacy of INS37217 inhalation solution, a novel P2Y2 receptor agonist, in patients with mild cystic fibrosis: Results of a Phase 2 multi-center study. Powerpoint and poster presentation at the 2004 North American Cystic Fibrosis Conference. 2004 October 14-17; St. Louis, Missouri, USA. Poster in PDF
Noone PG, Foy C, Shaffer C, Mathews D, Schaberg A, Boucher RC, Knowles MR. Dose effect for a novel P2Y2 agonist INS37217 to induce Cl- secretion across normal and CF airway epithelia. Poster presented at The Seventeenth Annual North American Cystic Fibrosis Conference. 2003 October 16-19; Anaheim, California, USA.
Kellerman D, Evans R, Mathews D, Shaffer C. Inhaled P2Y2 receptor agonists as a treatment for patients with Cystic Fibrosis lung disease. Adv Drug Deliv Rev. 2002 Dec 5;54(11):1463-1474.
Deterding R, Engels J, Shaffer C Kellerman D Mathews D LaVange L, Gorden J, Quittner A, Williams J, Ramsey B. Safety and tolerability of INS37217 inhalation solution, a novel P2Y2 receptor agonist, in patients with mild to moderate cystic fibrosis: Results of a Phase 1/2 multi-center study. Poster presented at the 2002 North American Cystic Fibrosis Conference. 2002 October 3-6; New Orleans, Louisiana, USA. Poster in PDF
Deterding R, Engels J, Shaffer C Kellerman D Mathews D LaVange L, Gorden J, Quittner A, Williams J, Ramsey B. Safety and tolerability of INS37217 inhalation solution, a novel P2Y2 receptor agonist, in patients with mild to moderate cystic fibrosis: Results of a Phase 1/2 multi-center study. Powerpoint presentation by Robin Deterding, MD at the 2002 North American Cystic Fibrosis Conference. 2002 October 3-6; New Orleans, Louisiana, USA.
Yerxa BR, Sabater JR, Davis CW, Stutts MJ, Lang-Furr M, Picher M, Jones AC, Cowlen M, Dougherty R, Boyer J, Abraham WM, Boucher RC. Pharmacology of INS37217 [P1-(uridine 5')-P4-(2'-deoxycytidine 5')tetraphosphate, Tetrasodium Salt], a next-generation P2Y2 receptor agonist for the treatment of cystic fibrosis. J Pharmacol Exp Ther, 2002 Sep, 302(3):871-880.
Kellerman DJ. P2Y2 receptor agonists: a new class of medication targeted at improved mucociliary clearance. Chest. 2002 May;121 (5 Suppl): 201S-205S.
Pendergast W and Evans R. P2Y Receptor Agonists: Role in Mucosal Hydration and Mucociliary Clearance. New Drugs for Asthma, Allergy and COPD, 2002, 31(5):165-168.
Noone PG, Hamblett N, Accurso F, Aitken ML, Boyle M, Dovey M, Gibson R, Johnson C, Kellerman D, Konstan MW, Milgram L, Mundahl J, Retsch-Bogort G, Rodman D, Williams-Warren J, Wilmott RW, Zeitlin P, Ramsey B. Safety of aerosolized INS365 in patients with mild to moderate cystic fibrosis: results of a Phase I multi-center study. Pediatr Pulmonol 2001 Aug; 32(2):122-128.
Mathews D, Kellerman D, Gorden J, Johnson C, Evans R. INS37217, a novel P2Y2 receptor agonist, being developed for the treatment of cystic fibrosis: results from initial Phase 1 study in normal volunteers. Poster presented at the 24th European Cystic Fibrosis Conference. 2001 June 6-9; Vienna, Austria.
Kellerman DJ, Bennett WD, Zeman KL, Foy C, Gorden JC, Shaffer CL, Johnson FL. Dose response relationship of the P2Y2 agonist INS365 on mucociliary clearance in smokers. Poster presented at the American Academy of Allergy, Asthma and Immunology 57th Annual Meeting. 2001 March 16-21; New Orleans, Louisiana, USA.
Evans R, Kaufman B, Kellerman D, Boyd B, Farr S, Taylor G, Warren S. Characterization of the in-vitro and in-vivo performance of two popular air-jet nebulizers. Poster presented at the American Academy of Allergy, Asthma and Immunology 57th Annual Meeting. 2001 March 16-21; New Orleans, Louisiana, USA.
Yerxa BR. Therapeutic use of nucleotides in respiratory and ophthalmic diseases. Drug Devel Res, 2001, 52:196-201.
Dougherty RW, Pendergast W, Abraham WM, Sabater JR, Davis CW. Effects of P2Y2 receptor agonists on cilia beat frequency in cultured human airway epithelia and on tracheal mucus velocity (TMV) in sheep. Poster presented at the North American Cystic Fibrosis Conference. 2000 November 9-12; Baltimore, Maryland, USA.
Dougherty RW, Redick CC, Sims I, Pendergast W, Douglass J, Lang-Furr M, Stutts MJ. Effects of INS37217 on activation of recombinant human P2Y receptors and chloride secretion by dog tracheal epithelium. Poster presented at the North American Cystic Fibrosis Conference. 2000 November 9-12; Baltimore, Maryland, USA.
Sabater JR, Mao YM, Shaffer C, James MK, O'Riordan TG, Abraham WM. Aerosolization of P2Y2-receptor agonists enhances mucociliary clearance in sheep. J Appl Physiol, 1999 Dec, 87(6):2191-2196.
Denufosol tetrasodium inhalation solution for cystic fibrosis - Phase 3
(diquafosol tetrasodium ophthalmic solution) 2% for dry eye - Phase 3; Approvable
(azithromycin ophthalmic solution) 1% for blepharitis - Phase 2
INS115644 and INS117548 for glaucoma - Phase 1
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