CytRx achieves key milestone in advancing tamibarotene Phase 2b trial for NSCLC

CytRx 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.

"We are optimistic about tamibarotene's prospects in advanced NSCLC based on clinical data indicating a statistically significant improvement in these patients when all-trans retinoic acid (ATRA) was combined with paclitaxel and cisplatin," said Daniel Levitt, MD, Ph.D., CytRx's Chief Medical Officer. "Tamibarotene appears to be 10-times more potent than ATRA and was designed to avoid several of the toxic side effects of ATRA by selectively binding to specific molecular receptors. The DSMB's recommendation to move forward with Phase 2b testing indicates that there are no significant safety issues seen thus far when tamibarotene is used with potent chemotherapy agents, even in patients with advanced disease."

A clinical trial conducted by Arrieta (the principal investigator for CytRx's clinical trial) et al. and published in the peer-reviewed Journal of Clinical Oncology (June 17, 2010) compared ATRA added to a regimen of paclitaxel plus cisplatin to a regimen of paclitaxel plus cisplatin alone as a treatment for patients with advanced NSCLC. The group administered ATRA plus the chemotherapeutic agents showed improved response rates of 55.8% versus 25.4%, and increased progression-free survival of 8.9 months versus 6.0 months. Median overall survival was increased from 9.5 months to 23.5 months when ATRA was added to the above chemotherapy regimen, representing a 14-month median extension of life.