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Journal Articles

Development of Oral Azacitidine with Cedazuridine for Myelodysplastic Syndrome (MDS) and Myeloproliferative Neoplasms (MPN) Including CMML (Chronic Myelomonocytic Leukemia) By Targeting Pharmacokinetic AUC Equivalence Vs Subcutaneous Azacitidine

Guillermo Garcia-Manero, James McCloskey, Bart L. Scott, Elizabeth A. Griffiths, Bonnie Kiner-Strachan, Gail J. Roboz, Janelle Meyer, Winny Chan, Beloo Mirakhur, Yuri Sano, Aram Oganesian, Harold N. Keer, Michael R. Savona

Blood (2023) 142 (Supplement 1): 3245.

https://doi.org/10.1182/blood-2023-178024

Published: 2023

Journal Articles

Oral Decitabine/Cedazuridine Vs Intravenous Decitabine for Acute Myeloid Leukemia: Final Results of a Randomized, Crossover, Registration-Enabling, Pharmacokinetics Study

Blood (2023) 142 (Supplement 1): 1538.

https://doi.org/10.1182/blood-2023-173092

Published: 2023

Journal Articles

ASTX727-03: Phase 1 Study Evaluating Oral Decitabine/Cedazuridine (ASTX727) Low-Dose (LD) in Lower-Risk Myelodysplastic Syndromes (LR-MDS) Patients

Guillermo Garcia-Manero, Kimo Bachiashvili, Harshad Amin, Elie Traer, Daniel A. Pollyea, David A. Sallman, Aref Al-Kali, Larry D. Cripe, Jesus G Berdeja, Elizabeth A. Griffiths, Sanjay R Mohan, Yuri Sano, Aram Oganesian, Harold N. Keer, Abdulraheem Yacoub

Blood (2022) 140 (Supplement 1): 1112–1114.

https://doi.org/10.1182/blood-2022-156512

Published: 2022

Journal Articles

Prolonged Survival in Bi-Allelic TP53 -Mutated ( TP53 mut) MDS Subjects Treated with Oral Decitabine/Cedazuridine in the Ascertain Trial (ASTX727-02)

Blood (2022) 140 (Supplement 1): 2066–2069.

https://doi.org/10.1182/blood-2022-163841

Published: 2022

Journal Articles

A Phase 1 Study Evaluating ASTX727 (decitabine and cedazuridine) and Venetoclax Combination Therapy in Newly Diagnosed AML Patients Unfit for Intensive Induction Chemotherapy

Gabriel N. Mannis, Elizabeth A. Griffiths, Michael R. Savona, Olatoyosi Odenike, Gail J. Roboz, Casey L. O'Connell, Jacqueline Dillingham, Prieya Wason, Lixia Zhu, Danna Chan, Harold N. Keer, Aram Oganesian, Kim-Hien Dao, Courtney D. DiNardo

Blood (2021) 138 (Supplement 1): 1245.

https://doi.org/10.1182/blood-2021-146264

Published: 2021

Journal Articles

Oral cedazuridine/decitabine for MDS and CMML: a phase 2 pharmacokinetic/pharmacodynamic randomized crossover study

Guillermo Garcia-Manero, Elizabeth A. Griffiths, David P. Steensma, Gail J. Roboz, Richard Wells, James McCloskey, II, Olatoyosi Odenike, Amy E. DeZern, Karen Yee, Lambert Busque, Casey O’Connell, Laura C. Michaelis, Joseph Brandwein, Hagop Kantarjian, Aram Oganesian, Mohammad Azab, Michael R. Savona

Blood (2020) 136 (6): 674–683.

https://doi.org/10.1182/blood.2019004143

Published: 2020

Journal Articles

Oral Azacitidine and Cedazuridine Approximate Azacitidine Efficacy in a Murine Model

Haley E. Ramsey, PhDMSc, Maria Arrate, MSc, Londa Fuller, Agnieszka E. Gorska, MSc, Kelli Boyd, DVM, PhD, Melissa A. Fischer, MSc, PhD, Aram Oganesian, PhD, Mohammad Azab, MD, Michael R. Savona, MD

Blood (2019) 134 (Supplement_1): 1376.

https://doi.org/10.1182/blood-2019-125899

Published: 2019

Journal Articles

Pharmacokinetic Exposure Equivalence and Preliminary Efficacy and Safety from a Randomized Cross over Phase 3 Study (ASCERTAIN study) of an Oral Hypomethylating Agent ASTX727 (cedazuridine/decitabine) Compared to IV Decitabine

Blood (2019) 134 (Supplement_1): 846.

https://doi.org/10.1182/blood-2019-122980

Published: 2019

Journal Articles

A Phase 2 Dose-Confirmation Study of Oral ASTX727, a Combination of Oral Decitabine with a Cytidine Deaminase Inhibitor (CDAi) Cedazuridine (E7727), in Subjects with Myelodysplastic Syndromes (MDS)

Guillermo Garcia-Manero, MD, Elizabeth A. Griffiths, MD, Gail J. Roboz, MD, Lambert Busque, MD, Richard A. Wells, MD DPhil, Olatoyosi Odenike, MD, David P. Steensma, MD, Karen W.L. Yee, MD, Stefan Faderl, Philip C. Amrein, MD, Laura C. Michaelis, MD, Hagop M. Kantarjian, MD, Aram Oganesian, James N. Lowder, MD, Mohammad Azab, MD, Michael R. Savona, MD

Blood (2017) 130 (Supplement 1): 4274.

https://doi.org/10.1182/blood.V130.Suppl_1.4274.4274

Published: 2017

Journal Articles

Successful Emulation of IV Decitabine Pharmacokinetics with an Oral Fixed-Dose Combination of the Oral Cytidine Deaminase Inhibitor (CDAi) E7727 with Oral Decitabine, in Subjects with Myelodysplastic Syndromes (MDS): Final Data of Phase 1 Study

Guillermo Garcia-Manero, MD, Olatoyosi Odenike, MD, Philip C. Amrein, MD, David P. Steensma, MD, Amy E. DeZern, MD MHS, Laura C. Michaelis, MD, Stefan Faderl, MD, Hagop M. Kantarjian, MD, James N. Lowder, MD, Pietro Taverna, PhD, Aram Oganesian, PhD, Xiaoping Zhang, PhD, Mohammad Azab, MD, Michael R. Savona, MD

Blood (2016) 128 (22): 114.

https://doi.org/10.1182/blood.V128.22.114.114

Published: 2016

Journal Articles

Results of First in Human (FIH) Phase 1 Pharmacokinetic (PK) Guided Dose-Escalation Study of ASTX727, a Combination of the Oral Cytidine Deaminase Inhibitor (CDAi) E7727 with Oral Decitabine in Subjects with Myelodysplastic Syndromes (MDS)

Michael R. Savona, MD, Olatoyosi Odenike, MD, Philip C. Amrein, MD, David P. Steensma, MD, Wael A. Harb, MD, Amy E. DeZern, MD MHS, Laura C. Michaelis, MD, Stefan Faderl, MD, James N. Lowder, MD, Pietro Taverna, PhD, Aram Oganesian, PhD, Richa Dua, PharmD, Roya Nawabi, Mohammad Azab, MD, Guillermo Garcia-Manero, MD

Blood (2015) 126 (23): 1683.

https://doi.org/10.1182/blood.V126.23.1683.1683

Published: 2015

Journal Articles

Preclinical Data In Cynomolgus (cyn) Monkeys Of ASTX727, a Novel Oral Hypomethylating Agent (HMA) Composed Of Low-Dose Oral Decitabine Combined With a Novel Cytidine Deaminase Inhibitor (CDAi) E7727

Aram Oganesian, PhD, Sanjeev Redkar, PhD, Pietro Taverna, PhD, Rajashree Joshi-Hangal, PhD, Mohammad Azab, MD

Blood (2013) 122 (21): 2526.

https://doi.org/10.1182/blood.V122.21.2526.2526

Published: 2013

Journal Articles

Results From the Dose Escalation Phase of a Randomized Phase 1–2 First-in-Human (FIH) Study of SGI-110, a Novel Low Volume Stable Subcutaneous (SQ) Second Generation Hypomethylating Agent (HMA) in Patients with Relapsed/Refractory MDS and AML

Blood (2012) 120 (21): 414.

https://doi.org/10.1182/blood.V120.21.414.414

Published: 2012

NARROW

Development of Oral Azacitidine with Cedazuridine for Myelodysplastic Syndrome (MDS) and Myeloproliferative Neoplasms (MPN) Including CMML (Chronic Myelomonocytic Leukemia) By Targeting Pharmacokinetic AUC Equivalence Vs Subcutaneous Azacitidine

Oral Decitabine/Cedazuridine Vs Intravenous Decitabine for Acute Myeloid Leukemia: Final Results of a Randomized, Crossover, Registration-Enabling, Pharmacokinetics Study

ASTX727-03: Phase 1 Study Evaluating Oral Decitabine/Cedazuridine (ASTX727) Low-Dose (LD) in Lower-Risk Myelodysplastic Syndromes (LR-MDS) Patients

Prolonged Survival in Bi-Allelic TP53 -Mutated ( TP53 mut) MDS Subjects Treated with Oral Decitabine/Cedazuridine in the Ascertain Trial (ASTX727-02)

A Phase 1 Study Evaluating ASTX727 (decitabine and cedazuridine) and Venetoclax Combination Therapy in Newly Diagnosed AML Patients Unfit for Intensive Induction Chemotherapy

Oral cedazuridine/decitabine for MDS and CMML: a phase 2 pharmacokinetic/pharmacodynamic randomized crossover study

Oral Azacitidine and Cedazuridine Approximate Azacitidine Efficacy in a Murine Model

Pharmacokinetic Exposure Equivalence and Preliminary Efficacy and Safety from a Randomized Cross over Phase 3 Study (ASCERTAIN study) of an Oral Hypomethylating Agent ASTX727 (cedazuridine/decitabine) Compared to IV Decitabine

A Phase 2 Dose-Confirmation Study of Oral ASTX727, a Combination of Oral Decitabine with a Cytidine Deaminase Inhibitor (CDAi) Cedazuridine (E7727), in Subjects with Myelodysplastic Syndromes (MDS)

Successful Emulation of IV Decitabine Pharmacokinetics with an Oral Fixed-Dose Combination of the Oral Cytidine Deaminase Inhibitor (CDAi) E7727 with Oral Decitabine, in Subjects with Myelodysplastic Syndromes (MDS): Final Data of Phase 1 Study

Results of First in Human (FIH) Phase 1 Pharmacokinetic (PK) Guided Dose-Escalation Study of ASTX727, a Combination of the Oral Cytidine Deaminase Inhibitor (CDAi) E7727 with Oral Decitabine in Subjects with Myelodysplastic Syndromes (MDS)

Preclinical Data In Cynomolgus (cyn) Monkeys Of ASTX727, a Novel Oral Hypomethylating Agent (HMA) Composed Of Low-Dose Oral Decitabine Combined With a Novel Cytidine Deaminase Inhibitor (CDAi) E7727

Results From the Dose Escalation Phase of a Randomized Phase 1–2 First-in-Human (FIH) Study of SGI-110, a Novel Low Volume Stable Subcutaneous (SQ) Second Generation Hypomethylating Agent (HMA) in Patients with Relapsed/Refractory MDS and AML

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American Society of Hematology

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American Society of Hematology

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