Apr 20, 2011 - Clinical Trial Data Could Be Available in Second Half of 2012 - Development of Tamibarotene for Potential Multibillion Dollar Market is Major Priority for CytRx - CytRx Corporation (Nasdaq:CYTR), a biopharmaceutical company specializing in oncology, has expanded enrollment to 15 clinical sites in its Phase 2b clinical trial with tamibarotene in combination with chemotherapeutical agents for the treatment of patients with advanced non-small-cell lung cancer (NSCLC). The large number of sites is expected to accelerate recruitment, and full enrollment of the approximately 140 patients is now anticipated in 12 months."We have opened enrollment in 15 clinical sites in the U.S. and Mexico for our tamibarotene clinical trial in 1st line NSCLC to expedite recruitment for an indication that could represent a blockbuster opportunity," said CytRx CEO Steven A. Kriegsman. "We expect these additional sites will accelerate enrollment, which means we could have data from this Phase 2b clinical trial by the end of 2012. What makes NSCLC so compelling is that it is responsible for more deaths than breast, prostate and ovarian cancers combined."
Daniel Levitt, MD, Ph.D., CytRx's Chief Medical Officer, said, "Tamibarotene is 10 times more potent than all trans retinoic acid (ATRA), while simultaneously showing properties that suggest it may lead to fewer adverse effects than ATRA. Recent published clinical data demonstrated that ATRA in combination with chemotherapeutical agents was statistically significant as a treatment for advanced NSCLC, which may open the door for tamibartotene based on its greater potency and lower side effect profile than ATRA."
In December 2010, CytRx initiated the Phase 2b clinical trial in patients with advanced NSCLC at a single clinical site. In this randomized clinical trial, patients with advanced NSCLC 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... CytRx's Press Release -
