Onyx Pharmaceuticals Announces Positive Top-Line Carfilzomib Data From Phase 2b Study

EMERYVILLE, Calif., July 26 /PRNewswire-FirstCall/ — Onyx
Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced positive top-line results
from the Phase 2b 003-A1 study of single-agent carfilzomib, a
selective, next generation proteasome inhibitor, in patients with
relapsed and refractory multiple myeloma.  In an independent
review of the data, carfilzomib achieved an overall response rate
(partial response or greater) of 24 percent and a median duration
of response of 7.4 months in patients who entered the study after
receiving a median of five prior lines of therapy (corresponding to
a median of 13 anti-myeloma agents) and whose disease was
refractory to their last therapeutic regimen. The clinical benefit
rate (minimal response or greater) in the study population was 36
percent.  Carfilzomib was well-tolerated and there were no new
or unexpected toxicities observed.  Full results of the trial
will be presented at an upcoming scientific meeting.  Based on
these results, Onyx is continuing discussions with the U.S. Food
and Drug Administration (FDA) regarding next steps in filing a new
drug application (NDA) for carfilzomib, which the company expects
to submit by year-end 2010 for potential accelerated approval in
the U.S.

“Despite recent advances in treating multiple myeloma, all
patients eventually relapse. The unmet medical need remains great,
as the outlook for patients with relapsed and refractory disease is
grim,” said Michael G. Kauffman,
M.D., Ph.D., Chief Medical Officer of Onyx Pharmaceuticals.
“According to a study from the International Myeloma Working Group,
patients, such as those enrolled in the 003-A1 study, can expect to
respond to therapy only 11 percent of the time and survive f

‘/>”/>

SOURCE