Entries by Renee Hansen

2019 ASH: Oral Azacitidine and Cedazuridine Approximate Azacitidine Efficacy in a Murine Model

View presentation Abstract # 1376 – Oral Azacitidine and Cedazuridine Approximate Azacitidine Efficacy in a Murine Model Authors: Haley E. Ramsey1-2, Maria P. Arrate1, Londa Fuller1, Agnieszka E. Gorska1, Kelli Boyd3-4, Melissa A. Fischer1-2, Aram Oganesian5, Mohammad Azab5, and Michael R. Savona1,2,4 1Department of Medicine, 2Cancer Biology Program, 3Department of Pathology, Microbiology and Immunology, 4Vanderbilt-Ingram Cancer Center; Vanderbilt University School of Medicine, […]

2019 ASH – 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

View Presentation Abstract # 846 – 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 Authors: Guillermo Garcia-Manero, MD1, James McCloskey, MD2, Elizabeth A. Griffiths, MD3, Karen W.L. Yee, MD4, Amer M. Zeidan, MBBS, MHS5, […]

ASH 2019: Landmark Response and Survival Analyses from 206 AML Patients Treated with Guadecitabine in a Phase 2 Study Demonstrate the Importance of Adequate Treatment Duration to Maximize Response and Survival Benefit. Survival Benefit Not Restricted to Patients with Objective Response

View Poster Abstract # 3846 – Landmark Response and Survival Analyses from 206 AML Patients Treated with Guadecitabine in a Phase 2 Study Demonstrate the Importance of Adequate Treatment Duration to Maximize Response and Survival Benefit. Survival Benefit Not Restricted to Patients with Objective Response Authors: Karen W.L. Yee, MD1, Gail J. Roboz, MD2, Casey […]

2019 ASH: Progression Free Survival (PFS), and Event Free Survival (EFS) from a Global Randomized Phase 3 Study of Guadecitabine (G) Vs Treatment Choice (TC) in 815 Patients with Treatment Naïve (TN) AML Unfit for Intensive Chemotherapy (IC): ASTRAL-1 Study

View Poster Abstract # 4235 – Progression Free Survival (PFS), and Event Free Survival (EFS) from a Global Randomized Phase 3 Study of Guadecitabine (G) Vs Treatment Choice (TC) in 815 Patients with Treatment Naïve (TN) AML Unfit for Intensive Chemotherapy (IC): ASTRAL-1 Study Authors: Jean-Pierre Issa, MD1*, Marco Gobbi, MD2*, Patricia L. Kropf, MD3*, […]

2019 ASH: Landmark Response and Survival Analyses from 102 MDS and CMML Patients Treated with Guadecitabine in a Phase 2 Study Showing That Maximum Response and Survival Is Best Achieved with Adequate Treatment Duration

View Poster Abstract # 2957 – Landmark Response and Survival Analyses from 102 MDS and CMML Patients Treated with Guadecitabine in a Phase 2 Study Showing That Maximum Response and Survival Is Best Achieved with Adequate Treatment Duration Authors: Michael R. Savona, MD1, Hagop M. Kantarjian, MD2, Gail J. Roboz, MD3, Casey L. O’Connell, MD4, […]

2019 ASH: Results from a Global Randomized Phase 3 Study of Guadecitabine (G) Vs Treatment Choice (TC) in 815 Patients with Treatment Naïve (TN) AML Unfit for Intensive Chemotherapy (IC) ASTRAL-1 Study: Analysis By Number of Cycles

View Poster Abstract #2591 Results from a Global Randomized Phase 3 Study of Guadecitabine (G) Vs Treatment Choice (TC) in 815 Patients with Treatment Naïve (TN) AML Unfit for Intensive Chemotherapy (IC) ASTRAL-1 Study: Analysis By Number of Cycles   Authors: Authors: Gail J. Roboz, MD1, Hartmut Döhner, MD2, Marco Gobbi, MD3*, Patricia L. Kropf, […]

Astex Pharmaceuticals announces that its novel, oral hypomethylating agent ASTX727 has been granted orphan drug designation for the treatment of myelodysplastic syndromes (including chronic myelomonocytic leukemia) by the US FDA

Pleasanton, CA, September 3rd, 2019. Astex Pharmaceuticals, Inc., a wholly owned subsidiary of Otsuka Pharmaceutical Co. Ltd., based in Tokyo, Japan, announces that the US Food & Drug Administration (FDA) has granted orphan drug designation for the company’s orally administered fixed-dose combination of cedazuridine and decitabine (ASTX727 or C-DEC) for the treatment of myelodysplastic syndromes […]