Cell Therapeutics, Inc. (CTI) Announces Encouraging Pixantrone Phase III Interim Data
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Independent Data Monitoring Committee Recommends Study Continue
SEATTLE, Aug. 8 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI)
(Nasdaq: CTIC; MTAX: CTIC) reported today that based on preliminary
encouraging confirmed and unconfirmed complete response (CR/uCR) rates
observed among the first 40 patients with aggressive non-Hodgkin's lymphoma
(NHL) treated in its randomized phase III trial of pixantrone, the Data
Monitoring Committee recommended that the study continue. The Company plans
to conduct a second interim analysis early next year.
"Consistent with the recent guidance from the U.S. Food and Drug
Administration's Deputy Commissioner regarding adaptive trial design, this
interim analysis allowed us to determine if the primary endpoint of the study
is tracking within our initial CR rate projections or substantially higher
than what was anticipated when the study was powered and initiated," said
Scott C. Stromatt, M.D., CTI's Executive Vice President of Clinical
Development and Regulatory Affairs. "Given the preliminary results reported
by the independent Data Monitoring Committee, we believe another analysis of
the primary endpoint after 100 patients have completed therapy is both
warranted and ethical."
About EXTEND
The EXTEND clinical trial is a phase III trial for patients with relapsed,
aggressive non-Hodgkin's lymphoma who have received two or more prior
therapies. The trial is being conducted in 130 sites in 17 countries.
Patients are randomized to receive either pixantrone or another single-agent
drug of physician's choice currently used for the treatment of this patient
population. The trial is designed to examine the complete response (CR) or
unconfirmed complete response (uCR) rate, time to tumor progression, and
overall survival. The study was powered based on a CR rate assumption of less
than 5 percent for the control arm and a 10 percent improvement in CR rate for
the pixantrone arm. The study is being conducted under a Special Protocol
Assessment from the U.S. Food and Drug Administration (FDA) and pixantrone has
received fast track designation for this indication.
About Pixantrone
Pixantrone is an investigational agent under development for the potential
treatment of various hematological malignancies, solid tumors and
immunological disorders. It was developed to improve the activity and safety
of the anthracycline family of anti-cancer agents. Anthracyclines have been
shown to be very active clinically in a number of tumor types. However, they
are usually associated with cumulative heart damage that prevents them from
being used in a large proportion of patients. Pixantrone has been designed to
reduce the potential for these severe cardiotoxicities, as well as to
potentially increase activity and simplified administration compared to the
currently marketed anthracyclines. |
