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CytRx Corporation
, a biopharmaceutical research and development
company specializing in oncology, announced that the Data Safety Monitoring
Committee overseeing the Company's 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) has
recommended conducting the clinical trial through completion. Enrollment of at
least 140 evaluable patients is expected in the first quarter of 2013.
“The Committee's recommendation indicates that no significant safety issues
have been seen with tamibarotene in the international Phase 2b clinical trial
as we near enrollment completion with tamibarotene's use in combination with
potent chemotherapy agents in patients with advanced NSCLC,” said CytRx CEO
Steven A. Kriegsman. “We are one step closer to completing this important
clinical trial and further assessing tamibarotene in a potential multibillion
dollar market, which is a major priority for our Company and our
shareholders.”
Subjects with stage IIIb or IV NSCLS who have not received prior non-adjuvant
chemotherapy are being enrolled in the blinded, randomized clinical trial at
sites in the U.S., Bulgaria, India, Mexico, Russia and Ukraine. 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 and quality-of-life in
this population, among other measures. The Data Safety Monitoring Committee is
an independent group of oncologists and biostatisticians who monitor the
safety and efficacy of the Phase 2b trial.
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