Serbian oncology centers participating in the trial include the Clinical Hospital Center Benzanijska Kosa in Belgrade, the Clinic for Pulmonary Diseases and TB ‘Knez Selo’ in Nis, and the Institute for Pulmonary Disease of Vojvodina in Sremska Kamenica. Serbia is said to be the first European country to open the Lucanix study for enrollment.
The study is an international, multicenter, randomized, double-blind study involving up to 700 individuals with advanced stage non-small cell lung cancer (NSCLC), and will be conducted at approximately 90 clinical sites in the US, Canada, Europe, and India. Treatment of patients in the Phase III Lucanix trial at multiple clinical centers began in the US in August 2008.
Lucanix is currently under clinical investigation and has not been approved for use in the US, Canada, Europe or elsewhere. The product has not been proved to be safe or effective, and any claims of safety and effectiveness can be made only after regulatory review of the data and approval of the labeled claims, the company said.
Norrie Russell, president and COO of NovaRx, said: “We are aggressively expanding the reach of our international Phase III trial of Lucanix and we are pleased Serbia is the first of many countries in Europe where this experimental treatment will be available for patients.”