CytRx Corporation a biopharmaceutical company specializing in oncology, has expanded enrolment to 15 clinical sites in its phase II b 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 enrolment of the approximately 140 patients is now anticipated in 12 months.
“We have opened enrolment in 15 clinical sites in the US 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 enrolment, 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, PhD, 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 II b 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.
A clinical trial conducted by Arrieta 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 chemotherapeutical 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.
More than 222,000 new cases of lung cancer will occur in the US this year and more than 1.5 million worldwide. Deaths due to lung cancer account for the majority of cancer-related deaths (157,000 in the US, 1.4 million worldwide) and the five-year survival ranges between 8-15%. NSCLC accounts for 85-90% of all lung cancers, with subsets adenocarcinoma representing 35-40%, squamous cell carcinoma accounting for 25-30% and large cell carcinoma accounting for 10-15% of lung cancers.
Tamibarotene is an orally available, rationally designed, synthetic retinoid compound. CytRx holds the North American and European rights to certain tamibarotene intellectual property for the treatment of NSCLC and APL, and retains an option to expand its licenses for the use of tamibarotene in other fields in oncology.
CytRx Corporation is a biopharmaceutical research and development oncology company engaged in the development of high-value human therapeutics. It also includes tamibarotene, which it is testing in patients with Non-Small-Cell Lung Cancer and which is in a registration clinical trial as a treatment for Acute Promyelocytic Leukaemia (APL).