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Journal Articles

Giroctocogene fitelparvovec gene therapy for severe hemophilia A: 104-week analysis of the phase 1/2 Alta study

Andrew D. Leavitt, Barbara A. Konkle, Kimo C. Stine, Nathan Visweshwar, Thomas J. Harrington, Adam Giermasz, Steven Arkin, Annie Fang, Frank Plonski, Anne Yver, Florence Ganne, Delphine Agathon, Maria de los Angeles Resa, Li-Jung Tseng, Gregory Di Russo, Bettina M. Cockroft, Liching Cao, Jeremy Rupon

Blood (2024) 143 (9): 796–806.

https://doi.org/10.1182/blood.2022018971

Published: 2024

Includes: Supplemental data

Journal Articles

The Effect of Tucaresol on Translational MRI Estimates of Cerebral Physiology in Townes SCD Mice

James A. Goodman, Yi-Fen Yen, Yinching Iris Chen, Suk-Tak Chan, Jonah P. Weigand Wittier, Jay M. Janz, Steven Arkin, Denis Rybin, Kelly Marie Knee, Debra D Pittman, Joseph B. Mandeville

Blood (2023) 142 (Supplement 1): 2491.

https://doi.org/10.1182/blood-2023-189037

Published: 2023

Journal Articles

Acute Events Significantly Increase Risk for Long-Term End-Organ Sequelae in Sickle Cell Disease - a Retrospective Cohort Study Using Optum Electronic Health Records

Xunming Sun, Steven Arkin, Yun Gu, Stephen E Schachterle, Xiaofeng Zhou, Thomas Edwards, Sherry Xiao, Kui A Huang

Blood (2023) 142 (Supplement 1): 5314.

https://doi.org/10.1182/blood-2023-177782

Published: 2023

Journal Articles

Four-Year Follow-up of the Alta Study, a Phase 1/2 Study of Giroctocogene Fitelparvovec (PF-07055480/SB-525) Gene Therapy in Adults with Severe Hemophilia Α

Thomas J. Harrington, Adam Giermasz, Nathan Visweshwar, Andrew D. Leavitt, Barbara A. Konkle, Jeremy Rupon, Gregory Dirusso, Li-Jung Tseng, Maria de los Angeles Resa, Florence Ganne, Delphine Agathon, Frank Plonski, Didier Rouy, Bettina M. Cockroft, Annie F. Fang, Steven Arkin

Blood (2023) 142 (Supplement 1): 1054.

https://doi.org/10.1182/blood-2023-179422

Published: 2023

Journal Articles

Progress: Responsiveness Validation of an Electronic Patient Reported Outcome (ePRO) in Adults with Sickle Cell Disease (NCT05407805)

Caterina P Minniti, Lanetta Bronte-Hall, Shannon Marraffino, Jason Healy, Denis Rybin, David Beidler, Lori Huang, Dana Shelton, Steven Taylor, Colet Goossens, Steven Arkin

Blood (2022) 140 (Supplement 1): 2564–2565.

https://doi.org/10.1182/blood-2022-166368

Published: 2022

Journal Articles

Updated Results of the Alta Study, a Phase 1/2 Study of Giroctocogene Fitelparvovec (PF-07055480/SB-525) Gene Therapy in Adults with Severe Hemophilia Α

Adam Giermasz, Nathan Visweshwar, Thomas J. Harrington, Andrew D Leavitt, Barbara Konkle, Jeremy Rupon, Gregory Di Russo, Li-Jung Tseng, Maria de los Angeles Resa, Florence Ganne, Delphine Agathon, Frank Plonski, Didier Rouy, Bettina M. Cockroft, Annie Fang, Steven Arkin

Blood (2022) 140 (Supplement 1): 7776–7777.

https://doi.org/10.1182/blood-2022-159421

Published: 2022

Journal Articles

Updated Results of the Alta Study, a Phase 1/2 Study of Giroctocogene Fitelparvovec (PF-07055480/SB-525) Gene Therapy in Adults with Severe Hemophilia a

Nathan Visweshwar, Thomas J. Harrington, Andrew D Leavitt, Barbara A. Konkle, Adam Giermasz, Kimo Stine, Jeremy Rupon, Gregory Di Russo, Li-Jung Tseng, Maria de los Angeles Resa, Florence Ganne, Delphine Agathon, Frank Plonski, Didier Rouy, Bettina M. Cockroft, Annie Fang, Steven Arkin

Blood (2021) 138 (Supplement 1): 564.

https://doi.org/10.1182/blood-2021-148651

Published: 2021

Journal Articles

Updated Follow-up of the Alta Study, a Phase 1/2 Study of Giroctocogene Fitelparvovec (SB-525) Gene Therapy in Adults with Severe Hemophilia a

Andrew D. Leavitt, MD, Barbara A. Konkle, MD, Kimo Stine, MD, Nathan Visweshwar, MD, Thomas J. Harrington, MD, Adam Giermasz, MD PhD, Steven Arkin, MD, Annie Fang, MD PhD, Frank Plonski, RN, MA, Lynne Smith, MBA, Li-Jung Tseng, PhD MBA, Gregory Di Russo, MD, Bettina M Cockroft, MD, Jeremy Rupon, MD, Didier Rouy, MD PhD

Blood (2020) 136 (Supplement 1): 12.

https://doi.org/10.1182/blood-2020-137648

Published: 2020

Journal Articles

Peak Thrombin and D-Dimer Levels in Subjects with Severe Hemophilia Receiving Acute Treatment for Bleeding Episodes Experienced during Prophylactic Marstacimab Treatment

Satyaprakash Nayak, PhD, Sangeeta Raje, PhD, John Teeter, MD, Lutz Harnisch, MD, Steven Arkin, MD

Blood (2020) 136 (Supplement 1): 33–34.

https://doi.org/10.1182/blood-2020-137581

Published: 2020

Journal Articles

Validation of Patient-Reported Vaso-Occlusive Crisis Day As a Potential Endpoint in Studies of Sickle Cell Disease

Karin Coyne, PhD, Brooke Currie, Michael U. Callaghan, MD, Kathleen W. Wyrwich, PhD, Sheryl Pease, MBA, Christine L. Baker, JD, MPH, Steven Arkin, MD, Debra D. Pittman, PhD

Blood (2020) 136 (Supplement 1): 17.

https://doi.org/10.1182/blood-2020-137464

Published: 2020

Journal Articles

Updated Follow-up of the Alta Study, a Phase 1/2, Open Label, Adaptive, Dose-Ranging Study to Assess the Safety and Tolerability of SB-525 Gene Therapy in Adult Patients with Severe Hemophilia A

Barbara A. Konkle, MD, Kimo Stine, MD, Nathan Visweshwar, MD, Thomas J. Harrington, MD, Andrew D. Leavitt, MD, Adam Giermasz, MD PhD, Steven Arkin, MD, Gregory Di Russo, MD, Ashley Snyder, PharmD, MPH, Adrian Woolfson, MD PhD, Didier Rouy, MD PhD

Blood (2019) 134 (Supplement_1): 2060.

https://doi.org/10.1182/blood-2019-122143

Published: 2019

Journal Articles

Escalating Single Doses of PF-05230907 (Recombinant Factor Xa Variant FXa I16L ) Are Safe and Demonstrate Hemostatic Pharmacology in Healthy Volunteers

Steven Arkin, MD, Fei Hua, PhD, Constantino Kantaridis, MD, Gang Li, PhD, Dana Parsons-Rich, MPH, MPA, Debra D Pittman

Blood (2016) 128 (22): 3781.

https://doi.org/10.1182/blood.V128.22.3781.3781

Published: 2016

Journal Articles

A Quantitative Systems Pharmacology Model for the Coagulation Network Describes Biomarker Changes Observed in a Clinical Study with FXa Variant and Predicts Age-Associated Biomarker Variations

Satyaprakash Nayak, PhD, Dooyoung Lee, PhD, Steven Arkin, MD, Steven W. Martin, PhD, Anne C. Heatherington, PhD, William S. Denney, PhD, Paolo Vicini, PhD, Fei Hua, PhD

Blood (2015) 126 (23): 3502.

https://doi.org/10.1182/blood.V126.23.3502.3502

Published: 2015

Journal Articles

Evaluation of Potential Safety Biomarkers for Monitoring Thrombogenic Potential of FXa I16L

Michael Bolt, PhD DABT, Fei Hua, PhD, Karrie Brenneman, DVM, PhD DACVP, John Graves, MT, MA, Steven Arkin, MD, Kay Criswell

Blood (2014) 124 (21): 4237.

https://doi.org/10.1182/blood.V124.21.4237.4237

Published: 2014

Journal Articles

A Systems Biology Model for the Coagulation Network in Non-Bleeding State Describes Baseline Activity of Coagulation

Dooyoung Lee, PhD, Satyaprakash Nayak, PhD, Debra Pittman, Steven Arkin, MD, Steven Martin, PhD, Anne C Heatherington, PhD, Paolo Vicini, PhD, Fei Hua, PhD

Blood (2014) 124 (21): 4238.

https://doi.org/10.1182/blood.V124.21.4238.4238

Published: 2014

Journal Articles

A Novel FVIIa Variant with Increased Potency and Duration of Effect Compared to Wildtype FVIIa. A Study in a Dog Model of Hemophilia A

Debra Pittman, MS, Stacey Weston, PhD, Kathleen Shields, BSc, Chuenlei Parng, PhD, Steven Arkin, MD, Ed Madison, PhD, Timothy C. Nichols, MD, Joachim Fruebis, PhD

Blood (2011) 118 (21): 2252.

https://doi.org/10.1182/blood.V118.21.2252.2252

Published: 2011

Journal Articles

Safety and efficacy of bosutinib (SKI-606) in chronic phase Philadelphia chromosome–positive chronic myeloid leukemia patients with resistance or intolerance to imatinib

Jorge E. Cortes, Hagop M. Kantarjian, Tim H. Brümmendorf, Dong-Wook Kim, Anna G. Turkina, Zhi-Xiang Shen, Ricardo Pasquini, H. Jean Khoury, Steven Arkin, Angela Volkert, Nadine Besson, Richat Abbas, Junyuan Wang, Eric Leip, Carlo Gambacorti-Passerini

Blood (2011) 118 (17): 4567–4576.

https://doi.org/10.1182/blood-2011-05-355594

Published: 2011

Includes: Supplemental data

Journal Articles

Efficacy and Safety of Bosutinib (SKI-606) in Patients with Chronic Phase (CP) Ph+ Chronic Myelogenous Leukemia (CML) with Resistance or Intolerance to Imatinib.

Jorge Cortes, MD, Hagop M Kantarjian, Dong- Wook Kim, MD, PhD, H. Jean Khoury, MD, FACP, Anna G. Turkina, MD, Zhi-Xiang Shen, MD, Tim H Brummendorf, MD, Mammen Chandy, MD, Steven Arkin, MD, Carlo Gambacorti-Passerini, MD

Blood (2008) 112 (11): 1098.

https://doi.org/10.1182/blood.V112.11.1098.1098

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

Bosutinib (SKI-606) Demonstrates Clinical Activity and Is Well Tolerated in Patients with AP and BP CML and Ph+ ALL.

Carlo Gambacorti- Passerini, Enrico Maria Pogliani, MD, Michele Baccarani, MD, Giovanni Martinelli, Hagop M Kantarjian, Mammen Chandy, H. Jean Khoury, MD, FACP, Dong-Wook Kim, Tim H Brummendorf, Steven Arkin, MD, Jorge Cortes

Blood (2008) 112 (11): 1101.

https://doi.org/10.1182/blood.V112.11.1101.1101

Published: 2008

NARROW

Giroctocogene fitelparvovec gene therapy for severe hemophilia A: 104-week analysis of the phase 1/2 Alta study

The Effect of Tucaresol on Translational MRI Estimates of Cerebral Physiology in Townes SCD Mice

Acute Events Significantly Increase Risk for Long-Term End-Organ Sequelae in Sickle Cell Disease - a Retrospective Cohort Study Using Optum Electronic Health Records

Four-Year Follow-up of the Alta Study, a Phase 1/2 Study of Giroctocogene Fitelparvovec (PF-07055480/SB-525) Gene Therapy in Adults with Severe Hemophilia Α

Progress: Responsiveness Validation of an Electronic Patient Reported Outcome (ePRO) in Adults with Sickle Cell Disease (NCT05407805)

Updated Results of the Alta Study, a Phase 1/2 Study of Giroctocogene Fitelparvovec (PF-07055480/SB-525) Gene Therapy in Adults with Severe Hemophilia Α

Updated Results of the Alta Study, a Phase 1/2 Study of Giroctocogene Fitelparvovec (PF-07055480/SB-525) Gene Therapy in Adults with Severe Hemophilia a

Updated Follow-up of the Alta Study, a Phase 1/2 Study of Giroctocogene Fitelparvovec (SB-525) Gene Therapy in Adults with Severe Hemophilia a

Peak Thrombin and D-Dimer Levels in Subjects with Severe Hemophilia Receiving Acute Treatment for Bleeding Episodes Experienced during Prophylactic Marstacimab Treatment

Validation of Patient-Reported Vaso-Occlusive Crisis Day As a Potential Endpoint in Studies of Sickle Cell Disease

Updated Follow-up of the Alta Study, a Phase 1/2, Open Label, Adaptive, Dose-Ranging Study to Assess the Safety and Tolerability of SB-525 Gene Therapy in Adult Patients with Severe Hemophilia A

Escalating Single Doses of PF-05230907 (Recombinant Factor Xa Variant FXa I16L ) Are Safe and Demonstrate Hemostatic Pharmacology in Healthy Volunteers

A Quantitative Systems Pharmacology Model for the Coagulation Network Describes Biomarker Changes Observed in a Clinical Study with FXa Variant and Predicts Age-Associated Biomarker Variations

Evaluation of Potential Safety Biomarkers for Monitoring Thrombogenic Potential of FXa I16L

A Systems Biology Model for the Coagulation Network in Non-Bleeding State Describes Baseline Activity of Coagulation

A Novel FVIIa Variant with Increased Potency and Duration of Effect Compared to Wildtype FVIIa. A Study in a Dog Model of Hemophilia A

Safety and efficacy of bosutinib (SKI-606) in chronic phase Philadelphia chromosome–positive chronic myeloid leukemia patients with resistance or intolerance to imatinib

Efficacy and Safety of Bosutinib (SKI-606) in Patients with Chronic Phase (CP) Ph+ Chronic Myelogenous Leukemia (CML) with Resistance or Intolerance to Imatinib.

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

Bosutinib (SKI-606) Demonstrates Clinical Activity and Is Well Tolerated in Patients with AP and BP CML and Ph+ ALL.

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American Society of Hematology

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American Society of Hematology

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