Corporation (NASDAQ: CYTR), a biopharmaceutical company specializing
in oncology, today announced the recommendation by the Data Safety
Monitoring Board (DSMB) to continue with the global Phase 2b clinical
trial with tamibarotene in combination with chemotherapeutical agents as
a first-line treatment for patients with advanced non-small-cell lung
cancer (NSCLC). The DSMB's pre-scheduled review of Phase 2b trial data
collected as of May 31, 2012 showed no significant difference in
drug-related severe or serious adverse events reported by trial patients
between those treated with tamibarotene and those treated with placebo.
The DSMB is an independent group of oncologists and biostatisticians who
monitor the safety and efficacy of the Phase 2b trial.
"We've achieved a key milestone in advancing the late-stage clinical
development of tamibarotene in a significant oncology indication that
claims more lives than breast, prostate and ovarian cancer combined,"
said CytRx CEO Steven A. Kriegsman. "We expect to report data from the
global Phase 2b clinical trial in 2013. There is no question that
effective treatment of metastatic NSCLC is a major unmet medical need
and that tamibarotene in this indication could represent an important
market opportunity for CytRx and our shareholders."
One hundred forty (140) evaluable patients with advanced NSCLC are being
enrolled at 25 clinical sites in the U.S., Mexico, Europe and India in
the double-blind, placebo-controlled Phase 2b trial. Trial patients are
treated with paclitaxel plus carboplatin and either tamibarotene or
placebo. The primary objective of this trial is to determine the
objective response rate (complete and partial responses) and
progression-free survival. Secondarily, the trial will evaluate overall
survival, quality-of-life and examine the pharmacokinetics of
tamibarotene in this population, among other measures.