Published: August 03, 2011
MMRF Announces Launch of Carfilzomib Expanded Access Program for Patients with Relapsed and Refractory Multiple Myeloma in Partnership with Onyx Pharmaceuticals
NORWALK, Conn. - (BUSINESS WIRE) - The Multiple Myeloma Research Foundation (MMRF) announced today that
through an innovative collaboration with Onyx Pharmaceuticals, it has
launched a new initiative to make carfilzomib available immediately
through an expanded access program to eligible patients in the United
States with relapsed and refractory multiple myeloma who have no
available treatment options.
The Carfilzomib Myeloma Access Program (C-MAP), launched today, will
enable eligible patients with relapsed and refractory multiple myeloma
to receive access to carfilzomib while it is still being evaluated in
Phase 3 clinical trials. Carfilzomib is an experimental, selective,
next-generation proteasome inhibitor that has shown early promise in
patients with relapsed and refractory multiple myeloma.
Working in partnership with Onyx Pharmaceuticals, the manufacturer of
carfilzomib, the MMRF is helping to provide new options to patients with
advanced multiple myeloma that are no longer responding to available
therapies. C-MAP is the first expanded access program for multiple
myeloma patients in nearly six years.
"The pre-approval access to carfilzomib is a tremendously important
development for the myeloma community that would not be possible without
a strong partnership with Onyx, the members of the Multiple Myeloma
Research Consortium (MMRC), and other clinical partners," said Kathy
Giusti, Founder and Chief Executive Officer of the MMRF and a multiple
myeloma patient. "We are proud of our role in driving this initiative
forward on behalf of patients, who are in urgent need of expanded
treatment options both today and over the long-term."
The MMRF and MMRC have been involved in the development of carfilzomib
for over 6 years, from early Phase 1 to the most recent Phase 2b studies
conducted within the MMRC and at additional sites in the U.S. and
Canada. To enable C-MAP, the MMRF developed the clinical platform for
this expanded access program and will provide a range of ongoing support
to ensure its successful completion, including patient and healthcare
provider communications, study site coordination, data management and
reporting, and overall project management.
About the Carfilzomib Myeloma Access Program (C-MAP)
Under C-MAP, approximately 40 medical centers across the U.S. will
enroll patients with relapsed and refractory multiple myeloma for whom
no satisfactory approved treatment alternatives are available and who do
not qualify for an existing carfilzomib clinical trial.
The trial is a single-arm study, meaning carfilzomib is not being
compared to another anti-cancer therapy. Refractory disease is defined
as progression during therapy or within 60 days after completion of
therapy. Onyx and the MMRF have made every effort to ensure geographical
balance of sites to provide as convenient access as possible to patients.
Eligible patients should ask their physician to call Onyx Medical
Information at 1-877-ONYX-1-2-1 (1-877-669-9121) or visit www.onyxtrials.com
to learn if they are eligible for the trial.
Patients will receive carfilzomib on 28-day cycles until disease
progression, unacceptable toxicity or until the drug is commercially
available. Per the treatment protocol, safety and certain efficacy data
will be collected.
Upon FDA approval and commercial availability, patients who are
receiving carfilzomib through C-MAP will be transitioned to commercially
available treatment. Patients without financial means to access
carfilzomib commercially will be assessed for eligibility into Onyx
assistance programs.
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 2010, more than 20,000 adults in the
United States were estimated to be diagnosed with multiple myeloma and
approximately 11,000 people died from the disease.
About the Multiple Myeloma Research Foundation (MMRF)
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
$170 million since its inception to fund nearly 120 laboratories
worldwide, including 70 new compounds and approaches in clinical trials
and pre-clinical studies and has facilitated more than 30 clinical
trials through its affiliate organization, the Multiple Myeloma Research
Consortium (MMRC). As exceptional stewards of its donors' investments,
the MMRF has been consistently recognized for its sound fiscal
management. For more information about the MMRF, please visit www.themmrf.org.
About the Multiple Myeloma Research Consortium
The 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. Baylor Charles A.
Sammons Cancer Center at Dallas, 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, Sarah Cannon Research Institute,
University Health Network (Princess Margaret Hospital), University of
California-San Francisco, University of Chicago, University of Michigan,
Virginia Cancer Specialists, and Washington University in St. Louis.
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.
About Onyx Pharmaceuticals, Inc.
Onyx Pharmaceuticals, Inc. is a biopharmaceutical company committed to
improving the lives of people with cancer. The company, in collaboration
with Bayer HealthCare Pharmaceuticals Inc., is developing and marketing
Nexavar (sorafenib) tablets, a small molecule drug that is currently
approved for the treatment of liver cancer and advanced kidney cancer.
Additionally, Nexavar is being investigated in several ongoing trials in
a variety of tumor types. Beyond Nexavar, Onyx has established a
development pipeline of anticancer compounds at various stages of
clinical testing, including carfilzomib, a selective proteasome
inhibitor, that is currently being evaluated in multiple clinical trials
for the treatment of patients with relapsed or relapsed/refractory
multiple myeloma and solid tumors. ONX 0801, an alpha-folate receptor
targeted inhibitor of thymidylate synthase, and ONX 0912, an oral
proteasome inhibitor, are currently in Phase 1 testing. For more
information about Onyx, visit the company's website at www.onyx-pharm.com.
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MMRF:
Eileen Regan, MMRF
203-652-0232
ReganE@themmrf.org
or
Krystle
Ficco, Feinstein Kean Healthcare
617-761-6702
Krystle.Ficco@fkhealth.com
or
Onyx
Pharmaceuticals:
Lori Melançon
650-266-2394
LMelancon@onyx-pharm.com
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