CAMBRIDGE, Mass.--(BUSINESS WIRE)--Genzyme
Corporation (Nasdaq: GENZ) announced results today from its CLASSIC
I phase 3 trial comparing Clolar® (clofarabine) in combination with the
chemotherapy agent cytarabine (ara-c) to cytarabine plus placebo in
relapsed-refractory adult acute myeloid leukemia (AML). Although the
study did not show a difference between the arms in the primary endpoint
of overall survival, the Clolar combination demonstrated statistical
significance across all four pre-specified secondary efficacy endpoints:
overall remission rate; complete remission rate; event-free survival;
and four-month event free survival.
“We remain committed to the development of Clolar in adult acute myeloid
leukemia”
“Of importance, the Clolar combination doubled the overall remission
rate to 47 percent,” said Hagop Kantarjian, M.D., MD Anderson Cancer
Center. “Also, we see a 37 percent improvement in event-free survival, a
particularly important measure of clinical benefit.”
Preliminary review of adverse events revealed no new safety signals.
“We remain committed to the development of Clolar in adult acute myeloid
leukemia,” said Mark Enyedy, Genzyme President of Transplant, Oncology,
and Multiple Sclerosis. “We are collaborating with the United Kingdom’s
National Cancer Research Institute on a large randomized clinical trial
in front-line adult AML.” Data from this study is anticipated in 2011.
The CLASSIC I study was a randomized, double-blind, placebo-controlled
clinical trial that compared Clolar in combination with cytarabine to
cytarabine plus placebo in patients 55 years and older with AML who
relapsed or were refractory after receiving up to two prior induction
regimens. The combination of Clolar with cytarabine was developed by
Stefan Faderl, M.D. and colleagues at the MD Anderson Cancer Center. Dr.
Faderl served as the principal investigator of CLASSIC I, which enrolled
326 patients in North America and Europe. The event driven trial was
powered to detect at least a 50 percent improvement in overall median
survival in the Clolar plus cytarabine combination arm.
The CLASSIC I study results will be submitted to an upcoming medical
meeting and discussed with regulatory authorities.
About Genzyme
One of the world's leading biotechnology companies, Genzyme is dedicated
to making a major positive impact on the lives of people with serious
diseases. Since 1981, the company has grown from a small start-up to a
diversified enterprise with approximately 10,000 employees in locations
spanning the globe and 2009 revenues of $4.5 billion. In 2010, Genzyme
was named to the Fortune 500.
With many established products and services helping patients in 100
countries, Genzyme is a leader in the effort to develop and apply the
most advanced technologies in the life sciences. The company's products
and services are focused on rare inherited disorders, kidney disease,
orthopaedics, cancer, transplant, and immune disease. Genzyme's
commitment to innovation continues today with a substantial development
program focused on these fields, as well as cardiovascular disease,
neurodegenerative diseases, and other areas of unmet medical need.
This press release contains forward-looking statements regarding
Genzyme’s future plans and business strategies, including its
expectations about the timing of results from the front-line adult AML
clinical trial and anticipated discussions with regulatory authorities
about the CLASSIC I study results. These statements are subject to risks
and uncertainties that could cause actual results to differ materially
from those projected in these forward-looking statements, including the
outcome and timing of the front-line adult AML trial, the timing and
outcome of discussions with regulatory agencies regarding Clolar, the
actual safety and efficacy of Clolar for the indications in which it is
being tested and the risks and uncertainties described in reports filed
by Genzyme with the Securities and Exchange Commission under the
Securities Exchange Act of 1934, as amended, including without
limitation the information under the heading “Risk Factors” in Genzyme’s
Quarterly Report on Form 10-Q for the quarter ending June 30, 2010.
Genzyme cautions investors not to place substantial reliance on the
forward-looking statements contained in this press release. These
statements speak only as of the date of this press release, and Genzyme
undertakes no obligation to update or revise these statements.
Genzyme® and Clolar® are registered trademarks of Genzyme Corporation or
its subsidiaries. All rights reserved.
Genzyme’s press releases and other company information are available at www.genzyme.com
and by calling Genzyme’s investor information line at 1-800-905-4369
within the United States or 1-678-999-4572 outside the United States.