In the news release, Onyx Pharmaceuticals Announces Carfilzomib
Data Presentations at 46th American Society of Clinical Oncology
Annual Meeting, issued 20-May-2010 by
Onyx Pharmaceuticals, Inc. over PR Newswire, we are advised by the
company that the second paragraph, last sentence, should read
"Following ASCO, we look forward to sharing final data from our
Phase 2b 003-A1 pivotal trial ..." rather than "We look forward to
sharing final data ..." as originally issued inadvertently. The
complete, corrected release follows:
Onyx Pharmaceuticals Announces Carfilzomib Data Presentations at
46th American Society of Clinical Oncology Annual Meeting
EMERYVILLE, Calif.,
May 20 /PRNewswire-FirstCall/ -- Onyx
Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced the
presentation of several studies evaluating carfilzomib, a
selective, next-generation proteasome inhibitor, at the 46th
American Society of Clinical Oncology (ASCO) Annual Meeting,
June 4-8, 2010 in Chicago, IL. Presentations will
highlight data from the carfilzomib development program in patients
with relapsed/refractory multiple myeloma and solid tumors.
Each presentation will include updated data at the annual
meeting that will not be available in the online abstracts at
www.asco.org.
"We are further encouraged by the growing body of evidence that
supports carfilzomib's potential as a new treatment option for
patients with multiple myeloma," said Ted
W. Love, M.D., Executive Vice President and Head of Research
and Development at Onyx. "Following ASCO, we look forward to
sharing final data from our Phase 2b 003-A1 pivotal trial that we
anticipate will form the basis of an initial New Drug Application
(NDA) filing for carfilzomib by year end."
Carfilzomib data presentations:
Multiple Myeloma
Results of an Ongoing Open-Label, Phase 2 Study of
Carfilzomib in Patients with Relapsed and/or Refractory Multiple
Myeloma (MM)
- Dr. Ravi Vij, Washington University School of Medicine
- Saturday, June 5, 2010,
4:30 - 6:00 p.m., E354a
- Clinical Science Symposium: Lymphoma and Plasma Cell
Disorders
- Abstract #8000
Dose Escalation Study of Carfilzomib Plus Lenalidomide and
Low Dose Dexamethasone (CRd) in Relapsed and Refractory Multiple
Myeloma (MM)
- Dr. William Besinger,
University of Washington School of
Medicine
- Friday, June 4, 2010,
8:00 a.m. - 12:00 p.m., S Hall
A2
- Poster session: Lymphoma and Plasma Cell Disorders
- Abstract #8029, poster board 8
Phase 2 Study of Carfilzomib in Patients with Relapsed or
Refractory Multiple Myeloma and Renal Insufficiency (MM)
- Dr. Ashraf Badros, University of Maryland School of Medicine
- Saturday, June 5, 2010,
9:00 a.m. - 12:00 p.m., S Hall
A2
- Poster session: Lymphoma and Plasma Cell Disorders
- Abstract #8128, poster board 36F
Neurotoxic and Peripheral Neuropathic Effects in Preclinical
and Clinical Studies of Carfilzomib, a Novel Proteasome Inhibitor
(PI)
- Dr. Jeffrey Wolf, University of California San Francisco
Comprehensive Cancer Center
- Saturday, June 5, 2010,
8:00 - 12:00 p.m., S Hall A2
- Poster session: Lymphoma and Plasma Cell Disorders
- Abstract #8135, poster board 37E
Solid Tumors & Multiple Myeloma
Updated Results of a Phase 1b/2 Study of Carfilzomib in
Patients with Relapsed Malignancies
- Dr. Peter Lee, Tower Cancer
Research Foundation
- Saturday, June 5, 2010,
8:00 a.m. - 12:00 p.m., S Hall
A2
- Poster session: Lymphoma and Plasma Cell Disorders
- Abstract #8147, poster board 39A
About the Carfilzomib Development Program
Carfilzomib is a selective, next generation proteasome inhibitor
that has shown encouraging results in a broad clinical trial
program in multiple myeloma.
In addition, the company intends to initiate a large, randomized
international Phase 3 clinical trial, known as the 009 trial, this
year to study the combination of lenalidomide and low dose
dexamethasone with or without carfilzomib in patients with relapsed
multiple myeloma. The company has an agreement with the U.S. Food
and Drug Administration (FDA) on a Special Protocol Assessment
(SPA) and received Scientific Advice from the European Medicines
Agency (EMEA) on the design and planned analysis of the 009 trial.
A second Phase 3 clinical trial, the 011 trial, of carfilzomib in
relapsed and refractory myeloma is planned in Europe. Carfilzomib is also being evaluated in
advanced solid tumors.
About Multiple Myeloma
Multiple myeloma (MM) is the second most common hematologic
cancer and results from an abnormality of plasma cells, usually in
the bone marrow. In the United
States, more than 50,000 people are living with MM and
approximately 20,000 new cases are diagnosed annually.(i)
Worldwide, more than 180,000 people are living with MM and
approximately 86,000 new cases are diagnosed annually.(ii)
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 next-generation 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 is a targeted alpha-folate
inhibitor currently in Phase 1 testing. For more information about
Onyx, visit the company's website at www.onyx-pharm.com.
Nexavar® (sorafenib) tablets is a registered trademark of Bayer
HealthCare Pharmaceuticals.
Forward Looking Statements
This news release contains "forward-looking statements" of
Onyx within the meaning of the federal securities laws. These
forward-looking statements include without limitation, statements
regarding the progress and results of the clinical development,
safety, regulatory processes, commercialization efforts or
commercial potential of carfilzomib. These statements are
subject to risks and uncertainties that could cause actual results
and events to differ materially from those anticipated, including
risks related to the development and commercialization of
pharmaceutical products. Any statements contained in this
press release that are not statements of historical fact may be
deemed to be forward-looking statements. Reference should be
made to Onyx's Annual Report on Form 10-K for the year ended
December 31, 2009, filed with the
Securities and Exchange Commission under the heading "Risk Factors"
and Onyx's Quarterly Reports on Form 10-Q for a more detailed
description of such factors. Readers are cautioned not to
place undue reliance on these forward-looking statements that speak
only as of the date of this release. Onyx undertakes no
obligation to update publicly any forward-looking statements to
reflect new information, events, or circumstances after the date of
this release except as required by law.
(i)National Cancer Institute, Surveillance Epidemiology and End
Results, 2007 Facts and Figures
(ii)International Agency for Research on Cancer, GLOBOCAN 2002
database
SOURCE Onyx Pharmaceuticals, Inc.