(NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, announced that enrollment of 140 evaluable patients has been completed in the Company’s global Phase 2b clinical trial with its oral retinoid compound tamibarotene in combination with chemotherapeutic agents as a first-line treatment for patients with advanced non-small-cell lung cancer (NSCLC).
“Tamibarotene could represent a multi-billion dollar market opportunity as a breakthrough in the treatment of NSCLC,” said CytRx CEO Steven A. Kriegsman. “We are delighted to have reached this major milestone in the clinical trial and expect to report top-line results from this trial in the second half of this year.”
More deadly than colon, breast and prostate cancers combined, lung cancer has a five-year survival rate of between 8-15%. Each year more than 220,000 new cases of this cancer are reported in the U.S. and more than 1.5 million cases reported worldwide. NSCLC accounts for approximately 85% of all lung cancers, and by 2015, the market for this cancer is projected to reach $13.3 billion.
Patients with stage IIIB or IV squamous or adenocarcinoma NSCLC who had not received prior non-adjuvant chemotherapy have been enrolled in the double-blind Phase 2b trial in clinical sites in the U.S., Bulgaria, India, Mexico, Russia and Ukraine. Patients are randomized for treatment in up to six cycles with paclitaxel plus carboplatin, with half receiving tamibarotene and half receiving placebo. The primary endpoint of the clinical trial is progression-free survival, and secondary endpoints include response rate, overall survival and RAR beta expression, a potential biomarker for responders.
“We made the decision to pursue this indication due primarily to results from a single-center Phase 2 clinical trial in which all trans-retinoic acid (ATRA) added to a regimen of paclitaxel plus cisplatin produced far superior results in late-stage NSCLC patients than a regimen of paclitaxel plus cisplatin alone,” said Daniel Levitt, MD, Ph.D., CytRx’s Executive Vice President and Chief Medical Officer. “In fact, response rates for patients receiving ATRA in this trial increased two-fold, progression-free survival increased by three months and median overall survival increased 14 months. Those results were published in the July 2010 issue of the peer-reviewed
Journal of Clinical Oncology
Tamibarotene was developed to be superior to ATRA, an approved retinoid, by binding to its molecular target more selectively. In preclinical models, tamibarotene has proven to be 10 times more potent than ATRA with milder side effects. CytRx holds the North American and European rights to certain tamibarotene intellectual property for the treatment of NSCLC. Tamibarotene is currently marketed in Japan for a rare form of leukemia.