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Journal Articles

Initial Results from SELECT-AML-1, a Phase 2 Study of Tamibarotene in Combination with Venetoclax and Azacitidine in RARA-Positive Newly Diagnosed AML Patients Ineligible for Standard Induction Chemotherapy

Suman Kambhampati, Christine M. McMahon, Alireza Eghtedar, Daniel A. Pollyea, Stephane de Botton, Arnaud Pigneux, Mohamad Cherry, Brian J Ball, Gautam Borthakur, Thomas Cluzeau, Gary J. Schiller, Beibei Hu, Angela Volkert, Joanie Aasen Gausman, Graeme Hodgson, David A. Roth, Erica D. Warlick, Michael J. Kelly, Eytan Stein

Blood (2022) 140 (Supplement 1): 3333–3335.

https://doi.org/10.1182/blood-2022-156564

Published: 2022

Journal Articles

SY-1425, a Potent and Selective RARα Agonist, in Combination with Azacitidine Demonstrates a High Complete Response Rate and a Rapid Onset of Response in RARA-Positive Newly Diagnosed Unfit Acute Myeloid Leukemia

Stephane De Botton, Thomas Cluzeau, MDPhD, Carlos Enrique Vigil, MD, Rachel J. Cook, MD, Philippe Rousselot, MDPhD, David A Rizzieri, MD, Jane L. Liesveld, MD, Pierre Fenaux, MD PhD, Thorsten Braun, MD PhD, Anne Banos, MD, Michael R. Savona, MD, Don Park, MD, Michael J. Kelly, MD MPH, MS, Angela Volkert, Li Zhou, PhD, Qing Kang-Fortner, PhD, David A. Roth, MD, Eytan M. Stein, MD

Blood (2020) 136 (Supplement 1): 4–5.

https://doi.org/10.1182/blood-2020-134600

Published: 2020

Journal Articles

Initial Results from a Biomarker-Directed Phase 2 Trial of SY-1425, a Potent and Selective RARα Agonist, in Combination with Azacitidine in Relapsed/Refractory Acute Myeloid Leukemia

Eytan M. Stein, MD, Stephane De Botton, Thomas Cluzeau, MDPhD, Arnaud Pigneux, MD PhD, Jane L. Liesveld, MD, Rachel J. Cook, MD, Philippe Rousselot, MDPhD, David A Rizzieri, MD, Thorsten Braun, MD PhD, Dale L. Bixby, MD, Gail J. Roboz, MD, Delphine Lebon, MD, Mael Heiblig, Michael J. Kelly, MD MPH, MS, Angela Volkert, Li Zhou, PhD, Qing Kang-Fortner, PhD, David A. Roth, MD, Pierre Peterlin, MD

Blood (2020) 136 (Supplement 1): 6–7.

https://doi.org/10.1182/blood-2020-134602

Published: 2020

Journal Articles

Selection of RARA-Positive Newly Diagnosed Unfit AML Patients with Elevated RARA Gene Expression Enriches for Features Associated with Primary Resistance to Venetoclax and Clinical Response to SY-1425, a Potent and Selective RARα Agonist, Plus Azacitidine

Christopher Fiore, PhD, Michael J. Kelly, MD MPH, MS, Angela Volkert, Li Zhou, PhD, Kate Madigan, MD, Matthew Eaton, PhD, Graeme Hodgson, PhD, David A. Roth, MD, Qing Kang-Fortner, PhD

Blood (2020) 136 (Supplement 1): 15–16.

https://doi.org/10.1182/blood-2020-137323

Published: 2020

Journal Articles

Early Results from a Biomarker-Directed Phase 2 Trial of Sy-1425 in Combination with Azacitidine or Daratumumab in Non-APL Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)

Rachel J. Cook, MD, Tamara Moyo, MD PhD, Jane L. Liesveld, MD, David A. Rizzieri, MD, Eytan M. Stein, MD, Stephane De Botton, MD PhD, Gail J. Roboz, MD, Mikkael A. Sekeres, MD MS, Joseph G. Jurcic, MD, Azra Raza, MD, Robert L. Redner, MD, Dale L. Bixby, MD PhD, Jorge E. Cortes, MD, Kristin Stephens, Angela Volkert, Qing Kang, PhD, Emmanuelle Di Tomaso, PhD, David A. Roth, MD, Carlos E Vigil, MD

Blood (2018) 132 (Supplement 1): 2735.

https://doi.org/10.1182/blood-2018-99-111285

Published: 2018

Journal Articles

Early Results from a Biomarker-Directed Phase 2 Trial of Sy-1425 in Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) Demonstrate DHRS3 Induction and Myeloid Differentiation Following Sy-1425 Treatment

Blood (2017) 130 (Supplement 1): 2633.

https://doi.org/10.1182/blood.V130.Suppl_1.2633.2633

Published: 2017

Journal Articles

Population Pharmacokinetic Modeling of BeneFIX in Pediatric and Adult Patients with Hemophilia B Demonstrates Weight as An Important Factor Contributing to Inter-Patient PK Variability.

Chandrasekhar Udata, PhD, Sharon Sullivan, PhD, Patrick Kelly, MD, David A. Roth, MD, Xu Meng, PhD

Blood (2008) 112 (11): 1218.

https://doi.org/10.1182/blood.V112.11.1218.1218

Published: 2008

Journal Articles

Investigator-Prescribed Prophylaxis of rFIX (BeneFIX ® ) in Children <6 Years of Age: Efficacy and Safety Outcomes.

Paul E. Monahan, MD, Raina Liesner, MD, Sharon Sullivan, PhD, Brooke Hayward, SM, Maria E. Ramirez, PhD, MPH, Patrick Kelly, MD, David A. Roth, MD

Blood (2008) 112 (11): 1221.

https://doi.org/10.1182/blood.V112.11.1221.1221

Published: 2008

Journal Articles

BDDrFVIII [moroctocog alfa (AF-CC), Xyntha] for Surgical Hemostasis in Patients with Hemophilia A: Results from a Pivotal Study.

Jerzy Windyga, MD, PhD, Luminita Rusen, MD, PhD, Amanda C. O’Brien, Brooke Hayward, SM, Steven Arkin, MD, David A. Roth, MD

Blood (2008) 112 (11): 1229.

https://doi.org/10.1182/blood.V112.11.1229.1229

Published: 2008

Journal Articles

Efficacy and Safety of ReFacto AF for Surgical Hemostasis in Previously Treated Patients with Severe Hemophilia A.

Jerzy Windyga, MD, PhD, Luminita Rusen, MD, Mona El-Hashimy, MD, David A. Roth, MD, Steven Arkin, MD

Blood (2007) 110 (11): 3960.

https://doi.org/10.1182/blood.V110.11.3960.3960

Published: 2007

Journal Articles

A New Formulation of Recombinant Human Factor IX Is Bioequivalent to BeneFIX: A Double-Blind, Randomized, Crossover Pharmacokinetic and Open-Label Safety and Efficacy Study.

Jerry Sherman Powell, MD, Thierry Lambert, MD, F. Hernández Navarro, MD, Michael Recht, MD, Sharon T. Sullivan, PhD, Chandrasekhar Udata, PhD, Leslie C. Lilly, BSN, RN, David A. Roth, MD, The rFIX-R Study Group

Blood (2005) 106 (11): 4076.

https://doi.org/10.1182/blood.V106.11.4076.4076

Published: 2005

Journal Articles

The safety and efficacy of recombinant human blood coagulation factor IX in previously untreated patients with severe or moderately severe hemophilia B

Amy D. Shapiro, Jorge Di Paola, Alice Cohen, K. John Pasi, Margaret A. Heisel, Victor S. Blanchette, Thomas C. Abshire, W. Keith Hoots, Jeanne M. Lusher, Claude Negrier, Chantal Rothschild, David A. Roth, for the Recombinant Factor IX Study Group

Blood (2005) 105 (2): 518–525.

https://doi.org/10.1182/blood-2004-06-2283

Published: 2005

Journal Articles

The vitamin K–dependent γ-glutamyl carboxylase gene contains a TATA-less promoter with a novel upstream regulatory element

Elizabeth E. Romero, Umaima Marvi, Zachary E. Niman, David A. Roth

Blood (2003) 102 (4): 1333–1339.

https://doi.org/10.1182/blood-2002-12-3833

Published: 2003

Journal Articles

Human recombinant factor IX: safety and efficacy studies in hemophilia B patients previously treated with plasma-derived factor IX concentrates

David A. Roth, Craig M. Kessler, K. John Pasi, Bonita Rup, Suzanne G. Courter, Karen L. Tubridy

Blood (2001) 98 (13): 3600–3606.

https://doi.org/10.1182/blood.V98.13.3600

Published: 2001

NARROW

Initial Results from SELECT-AML-1, a Phase 2 Study of Tamibarotene in Combination with Venetoclax and Azacitidine in RARA-Positive Newly Diagnosed AML Patients Ineligible for Standard Induction Chemotherapy

SY-1425, a Potent and Selective RARα Agonist, in Combination with Azacitidine Demonstrates a High Complete Response Rate and a Rapid Onset of Response in RARA-Positive Newly Diagnosed Unfit Acute Myeloid Leukemia

Initial Results from a Biomarker-Directed Phase 2 Trial of SY-1425, a Potent and Selective RARα Agonist, in Combination with Azacitidine in Relapsed/Refractory Acute Myeloid Leukemia

Selection of RARA-Positive Newly Diagnosed Unfit AML Patients with Elevated RARA Gene Expression Enriches for Features Associated with Primary Resistance to Venetoclax and Clinical Response to SY-1425, a Potent and Selective RARα Agonist, Plus Azacitidine

Early Results from a Biomarker-Directed Phase 2 Trial of Sy-1425 in Combination with Azacitidine or Daratumumab in Non-APL Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)

Early Results from a Biomarker-Directed Phase 2 Trial of Sy-1425 in Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) Demonstrate DHRS3 Induction and Myeloid Differentiation Following Sy-1425 Treatment

Population Pharmacokinetic Modeling of BeneFIX in Pediatric and Adult Patients with Hemophilia B Demonstrates Weight as An Important Factor Contributing to Inter-Patient PK Variability.

Investigator-Prescribed Prophylaxis of rFIX (BeneFIX ® ) in Children <6 Years of Age: Efficacy and Safety Outcomes.

BDDrFVIII [moroctocog alfa (AF-CC), Xyntha] for Surgical Hemostasis in Patients with Hemophilia A: Results from a Pivotal Study.

Efficacy and Safety of ReFacto AF for Surgical Hemostasis in Previously Treated Patients with Severe Hemophilia A.

A New Formulation of Recombinant Human Factor IX Is Bioequivalent to BeneFIX: A Double-Blind, Randomized, Crossover Pharmacokinetic and Open-Label Safety and Efficacy Study.

The safety and efficacy of recombinant human blood coagulation factor IX in previously untreated patients with severe or moderately severe hemophilia B

The vitamin K–dependent γ-glutamyl carboxylase gene contains a TATA-less promoter with a novel upstream regulatory element

Human recombinant factor IX: safety and efficacy studies in hemophilia B patients previously treated with plasma-derived factor IX concentrates

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American Society of Hematology

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ASH Publications

American Society of Hematology

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