(NASDAQ: CYTR), 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.
“Tamibarotene is an orally available, rationally designed, synthetic retinoid compound that is 10-times more potent than all-trans retinoic acid (ATRA) and was designed to avoid several side effects of ATRA,” said Daniel Levitt, MD, Ph.D., CytRx’s Executive Vice President and Chief Medical Officer. “This event is significant due to favorable results from a single-center clinical trial in patients with advanced NSCLC that compared treatment with ATRA added to a regimen of paclitaxel plus cisplatin to a regimen of paclitaxel plus cisplatin alone. Patients who received the regimen with ATRA showed improved response rates of 55.8% versus 25.4%, increased progression-free survival of 8.9 months versus 6.0 months, and a 14-month median extension of life.”