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Journal Articles

A Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study of Mitapivat in Patients with Sickle Cell Disease: RISE UP Phase 2 Results

Modupe Idowu, Lucas Otieno, Bogdan Dumitriu, Clarisse LC Lobo, Swee Lay Thein, Biree Andemariam, Obiageli E Nnodu, Adlette Inati, Alexander K Glaros, Sara Teresinha Olalla Saad, Pablo Bartolucci, Raffaella Colombatti, Ali T Taher, Miguel R Abboud, Abdulafeez Oluyadi, Varsha Iyer, Ophelia Yin, Susan Morris, Amber M Yates, Hui Shao, Spurthi Patil, Rolandas Urbstonaitis, Ahmar U Zaidi, Wally R Smith
Journal: Blood
Blood (2023) 142 (Supplement 1): 271.
https://doi.org/10.1182/blood-2023-187033
Published: 2023
Journal Articles

Results from the Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AG-946 in Healthy Volunteers

Xiaoshu Dai Gurov, Elizabeth Merica, Varsha Iyer, Annie Claeys, Spurthi Patil, Rolandas Urbstonaitis, James Xiao, Michael U. Callaghan
Journal: Blood
Blood (2022) 140 (Supplement 1): 5426–5427.
https://doi.org/10.1182/blood-2022-157719
Published: 2022
Journal Articles

A phase 1 dose escalation study of the pyruvate kinase activator mitapivat (AG-348) in sickle cell disease

Clinical Trials & Observations
Julia Z. Xu, Anna Conrey, Ingrid Frey, Eveline Gwaabe, Laurel A. Menapace, Laxminath Tumburu, Maureen Lundt, Timothy Lequang, Quan Li, Kristen Glass, Emily B. Dunkelberger, Varsha Iyer, Heidi Mangus, Charles Kung, Lenny Dang, Penelope A. Kosinski, Peter Hawkins, Neal Jeffries, William A. Eaton, Swee Lay Thein
Journal: Blood
Blood (2022) 140 (19): 2053–2062.
https://doi.org/10.1182/blood.2022015403
Published: 2022
Includes: Supplemental data
Journal Articles

Mitapivat (AG-348) Demonstrates Safety, Tolerability, and Improvements in Anemia, Hemolysis, Oxygen Affinity, and Hemoglobin S Polymerization Kinetics in Adults with Sickle Cell Disease: A Phase 1 Dose Escalation Study

Julia Z. Xu, Anna Conrey, Ingrid Frey, Eveline Gwaabe, Laurel A Menapace, Laxminath Tumburu, Maureen Lundt, Quan Li, Kristen Glass, Varsha Iyer, Heidi Mangus, Charles Kung, Lenny Dang, Penelope A. Kosinski, Peter Hawkins, Neal Jeffries, William Eaton, Swee Lay Thein
Journal: Blood
Blood (2021) 138 (Supplement 1): 10.
https://doi.org/10.1182/blood-2021-145398
Published: 2021
Journal Articles

Phase 1 Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AG-946 in Healthy Volunteers

Varsha Iyer, Elizabeth Merica, Sebastien Ronseaux, Tressa Gamache, Nancy J. Mulrow, Anja Belcijan, Michael U. Callaghan
Journal: Blood
Blood (2021) 138 (Supplement 1): 2043.
https://doi.org/10.1182/blood-2021-148381
Published: 2021
Journal Articles

Phase 1 Multiple Ascending Dose Study of Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Mitapivat (AG-348) in Subjects with Sickle Cell Disease

Julia Z. Xu, MDMS, Anna Conrey, NP, Ingrid Frey, RN, BSN, MS, James Nichols, RN, Laurel A Menapace, MD, Laxminath Tumburu, PhD, Timothy Lequang, MSc, Quan Li, PhD, Emily Dunkelberger, PhD, Eric Henry, PhD, Troy Cellmer, PhD, Varsha Iyer, Heidi Mangus, BS, Charles Kung, PhD, Lenny Dang, PhD, Penelope A. Kosinski, MS, Peter Hawkins, PhD, Neal Jeffries, PhD, William Eaton, MD, Swee Lay Thein, DSc, FRCP, MBBS, MRCP
Journal: Blood
Blood (2020) 136 (Supplement 1): 21–22.
https://doi.org/10.1182/blood-2020-137716
Published: 2020
Journal Articles

Expanded Phase 1 Study of ABL001, a Potent, Allosteric Inhibitor of BCR-ABL, Reveals Significant and Durable Responses in Patients with CML-Chronic Phase with Failure of Prior TKI Therapy

Timothy P. Hughes, MD FRACP, FRCPA, MBBS, FAAHMS, Yeow-Tee Goh, MBBS, MMed, Oliver G. Ottmann, MD, Hironobu Minami, MD PhD, Delphine Rea, MD PhD, Fabian Lang, MD, Michael J. Mauro, MD, Daniel J. DeAngelo, MD PhD, Moshe Talpaz, MD, Andreas Hochhaus, Prof. Dr., Massimo Breccia, MD, Jorge E. Cortes, MD, Michael C. Heinrich, MD, Jeroen Janssen, MD, Juan-Luis Steegmann, MD PhD, François-Xavier Mahon, MD PhD, Raina Duan, PhD, Varsha Iyer, David Hynds, MS, Gary J. Vanasse, MD, Dong-Wook Kim, MD PhD
Journal: Blood
Blood (2016) 128 (22): 625.
https://doi.org/10.1182/blood.V128.22.625.625
Published: 2016
Journal Articles

ABL001, a Potent, Allosteric Inhibitor of BCR-ABL, Exhibits Safety and Promising Single- Agent Activity in a Phase I Study of Patients with CML with Failure of Prior TKI Therapy

Oliver G. Ottmann, MD, Giuliana Alimena, Daniel J. DeAngelo, MD PhD, Yeow-Tee Goh, MBBS, MMed, Michael C. Heinrich, MD, Andreas Hochhaus, MD, Timothy P. Hughes, MD MBBS, FRACP, FRCPA, Francois-Xavier Mahon, MD PhD Professor, Michael J. Mauro, MD, Hironobu Minami, MD D.MDSci., Marie Huong Nguyen, MD, Delphine Rea, Juan Luis Steegmann, MD, Arkendu Chatterjee, Varsha Iyer, Noelia Martinez, Gary J. Vanasse, MD, Kim Dong-Wook, MD PhD
Journal: Blood
Blood (2015) 126 (23): 138.
https://doi.org/10.1182/blood.V126.23.138.138
Published: 2015
Journal Articles

ABL001, a Potent Allosteric Inhibitor of BCR-ABL, Prevents Emergence of Resistant Disease When Administered in Combination with Nilotinib in an in Vivo Murine Model of Chronic Myeloid Leukemia

Andrew Wylie, PhD, Joseph Schoepfer, Giuliano Berellini, Hongbo Cai, Giorgio Caravatti, Simona Cotesta, Stephanie Dodd, Jerry Donovan, Bernhard Erb, Pascal Furet, Geeti Gangal, Robert Grotzfeld, Quamrul Hassan, Tami Hood, Varsha Iyer, Sandra Jacob, Wolfgang Jahnke, Franco Lombardo, Alice Loo, Paul W. Manley, Ph. D., Andreas Marzinzik, Michael Palmer, Xavier Pelle, Bahaa Salem, Sreenath Sharma, Sanjeev Thohan, Suzanne Zhu, Nicholas Keen, Lilli Petruzzelli, MDPhD, K. Gary Vanasse, MD, William R Sellers, MD
Journal: Blood
Blood (2014) 124 (21): 398.
https://doi.org/10.1182/blood.V124.21.398.398
Published: 2014