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Astellas and Ambit Announce Data Presentations Highlighting Quizartinib at the American Society of Hematology 54th Annual Meeting
Date:11/6/2012

TOKYO and SAN DIEGO, Nov. 6, 2012 /PRNewswire/ -- Astellas Pharma Inc. (Tokyo: 4503, Astellas) and Ambit Biosciences Corporation (Ambit) today announced that five oral presentations and three poster presentations highlighting the findings from multiple clinical and translational research studies with the investigational agent, quizartinib (AC220), will be presented at the American Society of Hematology (ASH) 54thAnnual Meeting, December 8 - 11, 2012, at the Georgia World Congress Center in Atlanta, Georgia.  The abstracts can be accessed through the ASH website, http://hematology.org./.

"The data being presented at ASH demonstrate the commitment of the Ambit-Astellas alliance in bringing new options to patients suffering from AML, and we are excited to share this breadth of data from multiple clinical studies," said Wayne Klohs, PhD, Senior Vice President, Oncology Therapeutic Area Head, Astellas Pharma Global Development, Inc.

Oral Presentations

  • Final Results of a Phase 2 Open-Label, Monotherapy Efficacy and Safety Study of Quizartinib (AC220) in Patients >/_60 Years of Age with FLT3 ITD Positive or Negative Relapsed/Refractory Acute Myeloid Leukemia (abstract #48) will be presented by MD Anderson's Jorge Cortes, M.D., at 1:15 p.m. EST on Sunday, December 9, in Room A101. The presentation will take place during the Acute Myeloid Leukemia –Therapy, excluding Transplantation: Novel Therapies oral session.
  • Final Results of a Phase 2 Open-Label, Monotherapy Efficacy and Safety Study of Quizartinib (AC220) in Patients with FLT3-ITD Positive or Negative Relapsed/Refractory Acute Myeloid Leukemia After Second-Line Chemotherapy or Hematopoietic Stem Cell Transplantation (abstract #673) will be presented by the Johns Hopkins University's Mark Levis, M.D., Ph.D., at 4:30 p.m. EST on Monday, December 10, in Room A101. The presentation will take place during the Acute Myeloid Leukemia - Therapy, excluding Transplantation: New drugs in Acute Myeloid Leukemia oral session.
  • Constitutively Activating Mutations at the FLT3 Activation Loop Residue D835 Are Associated With Clinical Resistance to AC220 (abstract #674) will be presented by the University of California at San Francisco's Neil Shah, M.D., Ph.D, at 4:45 p.m. EST on Monday, December 10, in Room A101. This presentation will take place during the Acute Myeloid Leukemia – Therapy, excluding Transplantation oral session.
  • Global Phosphoproteome Analysis of AML Bone Marrow Reveals Predictive Markers for the Treatment with AC220(abstract #786) will be presented by Christoph Schaab, Ph.D. of Evotec GmbH, at 7:30 p.m. EST on Monday, December 10, in Room B206. This presentation will take place during the Leukemias - Biology, Cytogenetics and Molecular Markers in Diagnosis and Prognosis: The Role of Mutations in Acute Myeloid Leukemia oral session.
  • Diverse Histopathologic and Molecular Responses of Acute Myeloid Leukemia to the FLT3 Inhibitor Quizartinib (AC220) (abstract #885) will be presented by the University of Pennsylvania's Grant Nybakken, M.D.. Ph.D., at 8:00 a.m. EST on Tuesday, December 11, in Room A103. This presentation will take place during the Acute Myeloid Leukemia - Pathophysiology & Clinical Studies oral session.

Poster Presentations

  • Final Results of a Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Quizartinib (AC220) Administered Daily to Patients with Relapsed or Refractory Acute Myeloid Leukemia Irrespective of FLT3-ITD Status (abstract #1507) will be presented by MD Anderson's Jorge Cortes, M.D., from 5:30 – 7:30 p.m. EST on Saturday, December 8, in Hall B1-B2. The poster will be displayed during the Acute Myeloid Leukemia - Therapy, excluding Transplantation I poster session.
  • Single-Cell Pharmacodynamic Monitoring of Ribosomal Protein S6 Phosphorylation During AC220 Therapy Demonstrates In Vivo FLT3 Inhibition in Circulating Leukemic Blasts and Accurately Detects the Development of AC220 Resistance (abstract #2453) will be presented by the University of Pennsylvania's Alexander Perl, M.D., from 6 to 8 p.m. EST on Sunday, December 9, in Hall B1-B2. This poster will be displayed during the Molecular Pharmacology, Drug Resistance: Poster II session.
  • A Phase I Study of AC220 in Combination with Cytarabine and Etoposide in Relapsed/Refractory Childhood ALL and AML: A Therapeutic Advances in Childhood Leukemia & Lymphoma (TACL) Study (abstract #3605) will be presented by the AFLAC Cancer/Blood Disorder Center of Atlanta's Todd Cooper, DO, from 6 to 8 p.m. EST on Monday, December 10, in Hall B1-B2. This poster will be displayed during the Acute Myeloid Leukemia - Therapy, excluding Transplantation: Poster III session.

About Quizartinib
Quizartinib (AC220) is a novel, potent, highly selective, orally bioavailable FMS-like tyrosine kinase-3 (FLT3) inhibitor being developed in collaboration between Ambit Biosciences Corporation and Astellas Pharma Inc. Quizartinib is currently under evaluation in a Phase 2b clinical trial as monotherapy treatment for adult patients with relapsed or refractory AML, and in two Phase 1 studies in a combination treatment regimen with chemotherapy, and as a maintenance therapy following transplant, respectively.

About Ambit Biosciences
Ambit Biosciences is a privately held biopharmaceutical company engaged in the development of a robust pipeline of small molecule kinase inhibitors for the treatment of cancer, inflammatory disease and other indications. Ambit's lead compound, quizartinib (AC220), is a novel, potent, highly selective, orally bioavailable FMS-like tyrosine kinase-3 (FLT3) inhibitor, and is currently under clinical investigation in patients with relapsed or refractory AML and treatment-naïve AML. Ambit is developing quizartinib in collaboration with Astellas Pharma Inc. as part of a worldwide agreement to jointly develop and commercialize FLT3 kinase inhibitors in oncology and non-oncology indications. In addition to quizartinib, Ambit's clinical pipeline includes AC430, an oral JAK2 inhibitor, and CEP-32496, a BRAF inhibitor licensed to Teva. Ambit's preclinical portfolio includes a proprietary CSF1R inhibitor program. For more information, visit www.ambitbio.com.                                                      

About Astellas Pharma Inc.
Astellas Pharma Inc., located in Tokyo, Japan, is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceuticals. Astellas has approximately 17,000 employees worldwide. The organization is committed to becoming a global category leader in Urology, Immunology (including Transplantation) and Infectious Diseases, Oncology, Neuroscience and DM Complications and Kidney Diseases. For more information on Astellas Pharma Inc., please visit the company website at www.astellas.com/en.

Contacts:
Astellas:
Jenny Kite
Corporate Communications
847-682-4530

Ambit Biosciences:
Alan Fuhrman
Chief Financial Officer
(858) 334-2133

Ian Stone or David Schull (Media)
Russo Partners
(619) 308-6541
(212) 845-4271 
ian.stone@russopartnersllc.com 
david.schull@russopartnersllc.com


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