CytRx commences tamibarotene Phase 2b clinical trial in NSCLC

CytRx Corporation (Nasdaq: CYTR), a biopharmaceutical company specializing in oncology, today announced that it is initiating a multicenter Phase 2b clinical trial with its oncology drug candidate tamibarotene in combination with chemotherapeutical agents for the treatment of patients with advanced non-small-cell lung cancer (NSCLC).

"Intensive chemotherapy treatment for patients with late-stage NSCLC appears to provide some benefit; however, the median survival is still about one year, with progression-free survival of around six months," said CytRx Chief Medical Officer Daniel Levitt, MD, Ph.D. "A recent Phase 2 clinical trial demonstrated statistically significant results when adding All Trans Retinoic Acid, or ATRA to a regimen of paclitaxel and cisplatin as initial treatment for patients with advanced NSCLC. Tamibarotene is a synthetic retinoid that is 10- to 20-fold more potent than ATRA; thus we believe that it has great promise to be a new weapon against this devastating cancer."

The Phase 2 clinical trial conducted by Arrieta et al. and published in the peer-reviewed Journal of Clinical Oncology (2010; 28: 3463-3471) 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 chemotherapy 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.

In CytRx's randomized Phase 2b clinical trial, patients with stage IIIB or IV NSCLC will be treated with up to six cycles of paclitaxel plus carboplatin and either tamibarotene or placebo. The primary objective of the clinical trial is to determine the objective response rate (complete and partial responses) and progression-free survival. Secondarily, the study will evaluate overall survival, quality-of-life and the pharmacokinetics of tamibarotene in this population. The clinical trial, which is expected to enroll approximately 140 patients, will be conducted in several clinical sites in the U.S. and Mexico.

CytRx President and CEO Steven A. Kriegsman said, "Tamibarotene has shown highly encouraging results in patients with advanced acute promyelocytic leukemia or APL, with several reports of total elimination of the disease in patients who failed multiple other treatments. Due to its increased potency compared with ATRA and its ability to potentially avoid some of the toxic side effects of ATRA, tamibarotene could be a substantial improvement over ATRA for treating multiple cancers. In the event that tamibarotene shows a substantial extension of life for sufferers of non-small-cell lung cancer, it would present a multi-billion dollar market opportunity for CytRx."