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MMRF PRESS RELEASES


Multiple Myeloma Research Consortium (MMRC) Accelerates Clinical Trial Process


Thirteen MMRC-Associated Abstracts Presented at the 52nd ASH Annual Meeting and Exposition Are Proof of Model's Success

Orlando, FL — December 6, 2010

The Multiple Myeloma Research Consortium (MMRC) today announced that clinical trials conducted within the Consortium open 60% faster than the industry benchmark in oncology (D. Dilts, A. Sandler: Journal of Clinical Oncology 24:4545-4551), complete clinical trial enrollment two months (14%) earlier than the expected timeline, and enroll 25% more patients than the original MMRC commitment. These data are based on a retrospective review of 21 multiple myeloma trials conducted with MMRC project management resources from May 2006 to June 2010. The MMRC trial performance results were presented at the 52nd American Society of Hematology (ASH®) Annual Meeting and Exposition held here.

“The MMRC provides strategic solutions that have contributed toward the development of our selective proteasome inhibitor carfilzomib, including rapid accrual of patients and access to its network of institutions,” said Michael G. Kauffman, M.D., Ph.D., Chief Medical Officer of Onyx Pharmaceuticals. “We are grateful for the MMRC’s commitment to patients and for helping advance carfilzomib.”

Data from 10 additional MMRC-associated studies will be presented at ASH, including five oral presentations. Full data from the open-label, single-arm, Phase IIb study of carfilzomib in patients with relapsed and refractory multiple myeloma will be shared. In addition, initial data from the Phase I/II combination trial of carfilzomib, lenalidomide, and dexamethasone in newly diagnosed patients will be reported. Other data reported include a Phase I/II dose escalation study with pomalidomide and interim results from a Phase II Study of elotuzumab in combination with lenalidomide and dexamethasone in patients with relapsed multiple myeloma. In addition, an update from the Vantage Study Program evaluating vorinostat when combined with bortezomib in patients with relapsed or relapsed and refractory multiple myeloma will be presented as well as final Phase I results of perifosine in combination with lenalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma.

”The sheer number of MMRC-associated studies and the promising results that are being presented here truly reflect the success of our clinical trial model,” stated Kathy Giusti, Founder and Chief Executive Officer of the MMRC. “They are real-life examples of what can be accomplished when collaborative business solutions are developed to reduce inefficiencies and delays in drug development. The MMRC model succeeds due to the partnership and commitment we share with academic and industry partners to streamline drug development and bring new treatments to patients as quickly as possible.”

Additional MMRC studies presented at ASH:

Oral Presentations (Abstract Numbers in Bold):

Abstract #: 862
TITLE: Carfilzomib, Lenalidomide, and Dexamethasone In Newly Diagnosed Multiple Myeloma: Initial Results of Phase I/II MMRC Trial
MMRC Trial Lead Author: Andrzej J Jakubowiak, MD, PhD
Oral Session: Myeloma - Therapy, excluding Transplantation: Myeloma Phase I/II Trials and Correlative Studies
Date: Monday, December 6, 2010
Presentation Time: 7:00 PM
Location: 230 (Orange County Convention Center)

Abstract #: 864
TITLE: A Phase 1/2 Multi-Center, Randomized, Open Label Dose Escalation Study to Determine the Maximum Tolerated Dose, Safety, and Efficacy of Pomalidomide Alone or In Combination with Low- Dose Dexamethasone In Patients with Relapsed and Refractory Multiple Myeloma Who Have Received Prior Treatment That Includes Lenalidomide and Bortezomib
MMRC Trial Lead Author: Paul G Richardson, MD
Oral Session: Myeloma - Therapy, excluding Transplantation: Myeloma Phase I/II Trials and Correlative Studies
Date: Monday, December 6, 2010
Presentation Time: 7:30 PM
Location: 230 (Orange County Convention Center)

Abstract #: 985
TITLE: Results of PX-171-003-A1, An Open-Label, Single-Arm, Phase 2 (Ph 2) Study of Carfilzomib (CFZ) In Patients (pts) with Relapsed and Refractory Multiple Myeloma (MM)
MMRC Trial Lead Author: Paul G. Richardson, MD
Oral Session: Myeloma - Therapy, excluding Transplantation: Myeloma and Amyloidosis - Novel Drugs
Date: Tuesday, December 7, 2010
Presentation Time: 7:30AM
Location: Auditorium - 320 (Orange County Convention Center)

Abstract #: 986
TITLE: Elotuzumab In Combination with Lenalidomide and Dexamethasone In Patients with Relapsed Multiple Myeloma: Interim Results of a Phase 2 Study
MMRC Trial Lead Author: Paul G. Richardson, MD
Oral Session: Myeloma - Therapy, excluding Transplantation: Myeloma and Amyloidosis - Novel Drugs
Date: Tuesday, December 7, 2010
Presentation Time: 7:45 AM
Location: Auditorium - 320 (Orange County Convention Center)

Abstract #: 990
TITLE: Final Results of the Phase I/II Trial of Weekly Bortezomib In Combination with Temsirolimus (CCI-779) In Relapsed or Relapsed/Refractory Multiple Myeloma Specifically In Patients Refractory to Bortezomib
MMRC Trial Lead Author: Irene M. Ghobrial, MD
Oral Session: Myeloma - Therapy, excluding Transplantation: Myeloma and Amyloidosis - Novel Drugs
Date: Tuesday, December 7, 2010
Presentation Time: 8:45 AM
Location: Auditorium - 320 (Orange County Convention Center)

Poster Presentations (Abstract Numbers in Bold):

Abstract #: 1937
TITLE: Lenalidomide, Bortezomib, Pegylated Liposomal Doxorubicin, and Dexamethasone In Newly Diagnosed Multiple Myeloma (MM): Final Results of Phase I/II MMRC Trial
MMRC Trial Lead Author: Andrzej J Jakubowiak, MD, PhD
Poster Session: Myeloma - Therapy, excluding Transplantation: Poster I
Date: Saturday, December 4, 2010
Presentation Time: 5:30 PM-7:30 PM
Location: Hall A3/A4 (Orange County Convention Center)
Poster Board no: Poster Board I-917

Abstract #: 1938
TITLE: Carfilzomib: High Single Agent Response Rate with Minimal Neuropathy Even In High-Risk Patients
MMRC Trial Lead Author: Ravi Vij, MBBS, MD
Poster Session: Myeloma - Therapy, excluding Transplantation: Poster I
Date: Saturday, December 4, 2010
Presentation Time: 5:30 PM-7:30 PM
Location: Hall A3/A4 (Orange County Convention Center)
Poster Board no: Poster Board I-918

Abstract #: 1942
TITLE: Responses and Survival Are Not Affected by Cytogenetics In Patients with Relapsed and Refractory Multiple Myeloma (R/R MM) Treated with Single-Agent Carfilzomib
MMRC Trial Lead Author: Andrzej J Jakubowiak, MD, PhD
Poster Session: Myeloma - Therapy, excluding Transplantation: Poster I
Date: Saturday, December 4, 2010
Presentation Time: 5:30 PM-7:30 PM
Location: Hall A3/A4 (Orange County Convention Center)
Poster Board no: Poster Board I-922

Abstract #: 1952
TITLE: Vorinostat Combined with Bortezomib In Patients with Relapsed or Relapsed and Refractory Multiple Myeloma: Update on the Vantage Study Program
MMRC Trial Lead Author: David S Siegel, MD, PhD
Poster Session: Myeloma - Therapy, excluding Transplantation: Poster I
Date: Saturday, December 4, 2010
Presentation Time: 5:30 PM-7:30 PM
Location: Hall A3/A4 (Orange County Convention Center)
Poster Board no: Poster Board I-932

Abstract #: 3023
TITLE: Elotuzumab In Combination with Bortezomib In Patients with Relapsed/Refractory Multiple Myeloma: Updated Results of a Phase 1 Study
MMRC Trial Lead Author: Andrzej J Jakubowiak, MD, PhD
Poster Session: Myeloma - Therapy, excluding Transplantation: Poster II
Date: Sunday, December 5, 2010
Presentation Time: 6:00 PM-8:00 PM
Location: Hall A3/A4 (Orange County Convention Center)
Poster Board no: Poster Board II-903

Abstract #: 3031
TITLE: Baseline Peripheral Neuropathy does not Impact the Efficacy and Tolerability of the Novel Proteosome Inhibitor Carfilzomib: Results of a Subset Analysis of a Phase 2 Trial in Patients with Relapsed and Refractory Multiple Myeloma
MMRC Trial Lead Author: Tom Martin, MD
Poster Session: Myeloma - Therapy, excluding Transplantation: Poster II
Date: Sunday, December 5, 2010
Presentation Time: 6:00 PM-8:00 PM
Location: Hall A3/A4 (Orange County Convention Center)
Poster Board no: Poster Board II-911

Abstract #: 3064
TITLE: Final Phase I Results of Perifosine In Combination with Lenalidomide and Dexamethasone In Patients with Relapsed or Refractory Multiple Myeloma (MM)
MMRC Trial Lead Author: Andrzej J Jakubowiak, MD, PhD
Poster Session: Myeloma - Therapy, excluding Transplantation: Poster II
Date: Sunday, December 5, 2010
Presentation Time: 6:00 PM-8:00 PM
Location: Hall A3/A4 (Orange County Convention Center)
Poster Board no: Poster Board II-944

Abstract #: 3803
TITLE: The Multiple Myeloma Research Consortium (MMRC) Model: Reduced Time to Trial Activation and Improved Accrual Metrics
MMRC Trial Lead Author: Sandra Wear, RN
Poster Session: Health Services and Outcomes Research: Poster III
Date: Monday, December 6, 2010
Presentation Time: 6:00 PM-8:00 PM
Location: Hall A3/A4 (Orange County Convention Center)
Poster Board no: Poster Board III-582

About Multiple Myeloma
Multiple myeloma is an incurable blood cancer. The five-year relative survival rate for multiple myeloma is approximately 34 percent, one of the lowest of all cancers. In 2009, approximately 20,000 adults in the United States were diagnosed with multiple myeloma and approximately 11,000 people died from the disease.

About the Multiple Myeloma Research Foundation.
The Multiple Myeloma Research Foundation (MMRF) was established in 1998 as a 501(c)3 non-profit organization by twin sisters Karen Andrews and Kathy Giusti, soon after Kathy's diagnosis with multiple myeloma. The mission of the MMRF is to relentlessly pursue innovative means that accelerate the development of next-generation multiple myeloma treatments to extend the lives of patients and lead to a cure. As the world's number-one private funder of multiple myeloma research, the MMRF has raised over $150 million since its inception to fund nearly 100 laboratories worldwide. An outstanding 90% of funds raised go toward research and related programming. The MMRF has supported 40 new compounds and approaches in clinical trials and pre- clinical studies and has facilitated 26 clinical trials through its sister organization, the Multiple Myeloma Research Consortium (MMRC). For more information about the MMRF, visit www.themmrf.org.

About the Multiple Myeloma Research ConsortiumThe Multiple Myeloma Research Consortium (MMRC) is a 509(a)3 non-profit organization that integrates leading academic institutions to accelerate drug development in multiple myeloma. It is led from MMRC offices in Norwalk, Conn., and comprises 16 member institutions: University of California, San Francisco, City of Hope, Dana-Farber Cancer Institute, Emory University's Winship Cancer Institute, the John Theurer Cancer Center at Hackensack University Medical Center, H. Lee Moffitt Cancer Center & Research Institute, Mayo Clinic, Ohio State University, Mount Sinai School of Medicine, University Health Network (Princess Margaret Hospital), University of Chicago, University of Michigan, Washington University, Baylor Sammons Cancer Center, Sarah Cannon Cancer Center and Virginia Cancer Specialists.

The MMRC was founded in 2004 by Kathy Giusti, a myeloma patient, and with the help of the scientific community. The MMRC is a sister organization to the Multiple Myeloma Research Foundation (MMRF), the world's leading funder of multiple myeloma research. The MMRC is widely recognized as an optimal research model to rapidly address critical challenges in drug development and to explore opportunities in the today's most promising research areas in genomics, compound validation, and clinical trials. The MMRC is the only consortium to join academic institutions through membership agreements, customized IT systems, and an integrated tissue bank. For more information, please visit www.themmrc.org.

Media Contact:
Terri Clevenger
203-227-0209
tclevenger@continuumhealthcom.com