23.Jul.2012

OCT has overcome the enrollment number of 600 patients in one of the biggest clinical trials currently conducted by OCT

The GCP-compliant study is conducted in patients with recurrent epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer, the aim of the trial being to compare the efficacy and safety of the medicinal product.

In one of the currently conducted OCT phase III clinical trials, the number of 600 patients enrolled has been overcome. The trial in ovarian cancer indication is conducted among 650 patients throughout 35 sites in Russia, 15 sites in Ukraine, 6 sites in Bulgaria, 4 sites in Belarus, 2 sites in Lithuania, 1 site in Latvia and 1 in Estonia. The GCP-compliant study is conducted in patients with recurrent epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer, the aim of the trial being to compare the efficacy and safety of the medicinal product. Treatment shall last for six months in two parallel groups. The trial shall evaluate the activity of the active substance used in the two formulations. It was planned that all the patients would be enrolled in > 34 months.

OCT has already approached the target number and hopes to reach the final target number in the upcoming months. All the patients are randomized either to the experimental treatment or the control treatment group.

Yearly, more than 165,000 new cases of and 100,000 deaths from ovarian cancer are recorded.

The highest incidence rates are registered in the North America and the northern part of Europe (more than 12 in 100,000).

Roughly 3% of all cancer types account for ovarian cancer. Ovarian cancer is considered the ninth spread form of cancer in women, and the fifth cause of death among women. In the USA, estimated new cases in 2012 account for more than 22,000, and deaths amount to more than 15,000. In Russia, every year more than 11,000 women are diagnosed with ovarian cancer. If diagnosed and treated prior to tumor expanding to other organs, the 5-year survival for women constitutes around 90%.

The Sponsor company has several medicinal products, and OCT-Clinical Trials in Central and Estern Europe is conducting a number of other clinical trials together with the Company as well. We hope that successful outcomes of the trials will result in new good quality opportunities for patients and help them recover and improve their health state.