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Amgen And Onyx Pharmaceuticals Announce Upcoming Data Presentations At 55th American Society Of Hematology Annual Meeting

THOUSAND OAKS and SOUTH SAN FRANCISCO, Calif., Nov. 7, 2013 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and its subsidiary Onyx Pharmaceuticals, Inc. today announced that nearly 40 company-sponsored and investigator-sponsored investigational studies evaluating carfilzomib, a second-generation proteasome inhibitor, and oprozomib, an oral second-generation proteasome inhibitor in early development, will be presented at the 55 th American Society of Hematology (ASH) Annual Meeting and Exposition on December 7-10, 2013 at the Ernest N. Morial Convention Center in New Orleans, LA.

"We are encouraged by the breadth of data from our Proteasome Inhibitor franchise being presented this year at ASH, which add to the clinical data of carfilzomib in combination with other therapies and provide further insight into the level of response for carfilzomib at a molecular level. Additionally, data to be presented on oprozomib offer clinical insights instrumental in driving forward our clinical development program for the compound," said Pablo Cagnoni, M.D., President of Onyx Pharmaceuticals, Inc.  "We remain committed to bringing innovative therapies to patients in need, and we look forward to playing a continued role in advancing the scientific understanding of hematologic malignancies."

Among the presentations are five abstracts from the Proteasome Research and Integrative Science for Multiple Myeloma – Novel Therapies Program ( PRISM NTP), a global research collaboration between Onyx, investigators at myeloma centers of excellence and partner companies with novel therapies in development. "The PRISM program further demonstrates our commitment to innovation and advancing science," said Homa Yeganegi, Vice President of Scientific Affairs at Onyx Pharmaceuticals, Inc.  "This program is a highly innovative approach to industry-academia collaboration, bringing together leaders from the myeloma research community in the service of a common goal: driving an integrated, personalized approach to the development and delivery of medicines to patients."

Company-sponsored carfilzomib and oprozomib abstracts:

A Phase 1, Dose-Escalation Study (CHAMPION-1) Investigating Weekly Carfilzomib in Combination with Dexamethasone for Patients with Relapsed or Refractory Multiple Myeloma
  • Dr. James R. Berenson, Institute for Myeloma & Bone Cancer Research
  • Saturday, December 7, 5:30 pm - 7:30 pm CT, Hall G
  • Poster presentation: Myeloma: Therapy, excluding Transplantation: Poster I
  • Abstract # 1934

Association of Treatment Induced Peripheral Neuropathy (TIPN) with Treatment Patterns and Outcomes in Patients (pts) with Newly Diagnosed Multiple Myeloma (NDMM)
  • Dr. Thomas Martin, University of California, San Francisco
  • Saturday, December 7, 5:30 pm - 7:30 pm CT, Hall G
  • Poster presentation: Health Services and Outcomes Research: Poster I
  • Abstract # 1750

Relationship of Serum Free Light Chain Reduction to Best Overall Response in Phase 2 Single-Agent and Combination Studies of Carfilzomib in Patients with Relapsed or Relapsed and/or Refractory Multiple Myeloma
  • Dr. Ravi Vij, Washington University School of Medicine, St. Louis, MO
  • Saturday, December 7, 5:30 pm - 7:30 pm CT, Hall G
  • Poster presentation: Myeloma: Therapy, excluding Transplantation: Poster I
  • Abstract # 1965

Clinical Profile of Single-Agent Modified-Release Oprozomib Tablets in Patients (Pts) With Hematologic Malignancies: Updated Results From a Multicenter, Open-Label, Dose Escalation Phase 1b/2 Study
  • Dr. Irene M. Ghobrial, Dana-Farber Cancer Institute
  • Sunday, December 8, 6:30 pm - 8:30 pm CT, Hall G
  • Poster presentation: Myeloma: Therapy, excluding Transplantation: Poster II
  • Abstract # 3184

Select Investigator-Sponsored carfilzomib abstracts:

Dose Escalation Phase 2 Trial Of Carfilzomib Combined With Thalidomide and Low-Dose Dexamethasone In Newly Diagnosed, Transplant Eligible Patients With Multiple Myeloma. A Trial Of The European Myeloma Network
  • Dr. Pieter Sonneveld, Erasmus Medical Center, Rotterdam, Netherlands
  • Monday, December 9, 5:15 pm CT, 393-394
  • Oral Presentation: Myeloma: Therapy, excluding Transplantation II
  • Abstract # 688

A Phase II Study with Carfilzomib, Cyclophosphamide and Dexamethasone (CCd) for Newly Diagnosed Multiple Myeloma
  • Dr. Sara Bringhen, Myeloma Unit, Division of Hematology, University of Torino, Torino, Italy
  • Monday, December 9, 4:30 pm CT, 393-394
  • Oral presentation: Myeloma: Therapy, excluding Transplantation II
  • Abstract # 685

A simple score, based on geriatric assessment, improves prediction of survival, and risk of serious adverse events in elderly newly diagnosed multiple myeloma patients
  • Dr. Alessandra Larocca, Myeloma Unit, Division of Hematology, University of Torino, Torino, Italy
  • Monday, December 9, 5:00 pm CT, 393-394
  • Oral presentation: Myeloma: Therapy, excluding Transplantation II
  • Abstract # 687

Phase II Clinical and Correlative Study of Carfilzomib, Lenalidomide, and Dexamethasone (CRd) Followed by Lenalidomide Extended Dosing (CRD-R) Induces High Rates of MRD Negativity in Newly Diagnosed Multiple Myeloma (MM) Patients
  • Dr. Neha Korde, Multiple Myeloma Section, National Cancer Institute, National Institutes of Health
  • Monday, December 9, 3:30 pm CT, 393-394
  • Oral presentation: Myeloma: Therapy, excluding Transplantation: Treatment Options for Newly Diagnosed Multiple Myeloma Patients
  • Abstract # 538

Serum Heavy-Light Chains (HLC) and Free Light Chains (FLC) As Predictors For Early CR In Newly Diagnosed Myeloma Patients Treated With Carfilzomib, Lenalidomide, and Dexamethasone (CRd)
  • Dr. Manisha Bhutani, Multiple Myeloma Section, National Cancer Institute, National Institutes of Health
  • Monday, December 9, 7:30 pm CT, 393-394
  • Oral presentation: Myeloma: Therapy, excluding Transplantation: Advances in Multiple Myeloma and Plasma Cell Leukemia
  • Abstract # 762

Phase I/II Dose Expansion of a Multi-Center Trial of Carfilzomib and Pomalidomide with Dexamethasone (Car-Pom-d) in Patients with Relapsed/Refractory Multiple Myeloma
  • Dr. Jatin Shah, The University of Texas MD Anderson Cancer Center
  • Monday, December 9, 5:45 pm CT, 393-394
  • Oral presentation: Myeloma: Therapy, excluding Transplantation II
  • Abstract # 690

Carfilzomib, Rituximab and Dexamethasone (CaRD) is highly active and offers a neuropathy sparing approach for proteasome-inhibitor based therapy in Waldenstrom's Macroglobulinemia
  • Dr. Steven Peter Treon, Bing Center for Waldenstrom Macroglobulinemia, Dana-Farber Cancer Institute
  • Monday, December 9, 6:15 pm CT, 393-394
  • Oral presentation: Myeloma: Therapy, excluding Transplantation: Advances in Multiple Myeloma and Plasma Cell Leukemia
  • Abstract # 757

PRISM data highlights:

A Novel Bruton's Tyrosine Kinase Inhibitor CC-292 in Combination with the Proteasome Inhibitor Carfilzomib Impacts Multiple Myeloma Bone Microenviroment with Resultant Anti-myeloma Activity
  • Dr. Homare Eda, MGH Cancer Center, Massachusetts General Hospital
  • Monday, December 9, 5:15 pm CT, 388-390
  • Oral presentation: Myeloma: Biology and Pathophysiology, excluding Therapy: Bone Marrow Microenvironment and Myeloma Session
  • Abstract # 682

Phase 1 Study of the Novel Kinesin Spindle Protein Inhibitor ARRY-520 + Carfilzomib (Car) in Patients with Relapsed and/or Refractory Multiple Myeloma (RRMM)
  • Dr. Jatin Shah, The University of Texas MD Anderson Cancer Center
  • Saturday, December 7, 5:30 pm - 7:30 pm CT, Hall G
  • Poster presentation: Myeloma: Therapy, excluding Transplantation: Poster I
  • Abstract # 1982

Inhibition of Autophagy by ACY-1215, a Selective HDAC 6 Inhibitor Accelerates Carfilzomib-Induced Cell Death in Multiple Myeloma
  • Dr. Yuko Mishima, Massachusetts General Hospital Cancer Center
  • Monday, December 9, 6:00 pm - 8:00 pm CT, Hall G
  • Poster presentation: Myeloma: Pathophysiology and Pre-Clinical Studies, excluding Therapy: Poster III
  • Abstract # 4431

Dual Inhibition of Mcl-1 By The Combination Of Carfilzomib and TG02 In Multiple Myeloma
  • Dr. Katelyn Barnhart, Cancer Biology Graduate Program, Emory University
  • Sunday, December 8, 6:30 pm - 8:30 pm CT, Hall G
  • Poster presentation: Myeloma: Pathophysiology and Pre-Clinical Studies, excluding Therapy: Poster II
  • Abstract # 3171

Combined Carfilzomib and Selective PI3Kδ Inhibition (TGR1202) Results in Enhanced Myeloma Cell Apoptosis
  • Dr. Claire Torre, Winship Cancer Institute, Emory University
  • Sunday, December 8, 6:30 pm - 8:30 pm CT, Hall G
  • Poster presentation: Myeloma: Therapy, excluding Transplantation: Poster II
  • Abstract # 3224

About PRISM

PRISM NTP (Proteasome Research and Integrative Science for Multiple Myeloma - Novel Therapies Program) is a global research collaboration between Onyx, investigators at myeloma centers of excellence and partner companies with novel therapies in development. PRISM NTP members come from five centers in the United States (Dana-Farber Cancer Institute/Partners, Emory, MD Anderson Cancer Center, Mayo Clinic Scottsdale and Mayo Clinic Rochester) and seven countries in Europe ( France, Germany, Greece, Italy, Netherlands, Spain, United Kingdom). The program co-chairs are Dr. Kenneth C. Anderson, Dana-Farber Cancer Institute, Boston and Dr. Jesus San Miguel, University of Navarra, Spain.  There are three working groups led by experts for each area of focus: molecular profiling, pre-clinical and clinical trial. 

About AmgenAmgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be the world's largest independent biotechnology company, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

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