Atlant Clinical has successfully completed an international, multicenter, double-blind, placebo-controlled, Phase IIIa study in patients with prostate cancer.
The trial included a screening of more than 900 patients aged from 18 to 65 in 13 countries. A total of 620 patients were randomised and 607 trial participants completed the study. There were 37 investigational sites initiated for patient enrollment, which was completed in 15 months.
Atlant Clinical provided end-to-end clinical trial services from study start-up to study close-out in Poland, Germany, Ukraine, Hungary, Romania, Spain, Georgia, Latvia, Lithuania, and Belgium, and was responsible for clinical monitoring in the US, France, and the UK. The trial was audited several times during the study with no major findings.
According to Global Cancer Fact Sheets, prostate cancer is the second most common cancer in men and the fourth most common in both sexes combined. Almost 70% of the prostate cancer occurring are registered in developed nations.
Chief executive officer of Atlant Clinical Michael Groubman said: "The completion of the study makes an important step towards developing a novel approach to treatment of prostate cancer, one of the most common conditions in oncology.
"We are proud of successfully completing this large study and are grateful to our sponsor for placing its trust with us. We stay committed to our mission of effectively contributing to delivery of new drugs to patients by working with pharmaceutical and biotech companies and assisting them in conduct of clinical trials.
"We look forward to continue our efforts in further clinical development of novel compounds proving its safety and efficacy."