28.May.2010

OCT is awarded with a Phase III Clinical Trial in Sore Throat

OCT is very excited about the opportunity to run the Phase III clinical trial in sore throat.

A sore throat is a common symptom of the cold or another acute respiratory tract infection which may be sustained when somebody is sick. It can often lead to difficulties and pain when trying to swallow, some other symptoms associated with this infection are leaving the throat dry and scratchy. The most common forms of sore throats are caused by viruses, similar to that of the flu or a cold. Another form of sore throat is strep throat, which is caused by a bacterial infection; it can also be caused by allergies, dry air, pollution (airborne chemicals), and smoking directly or exposure to second hand smoke.

OCT is very excited about the opportunity to run the Phase III clinical trial in sore throat. The Sponsor is a leading European pharmaceutical company. There are multiple aspects of the study drug, which will be tested starting with the parameters of the treatment of the effect of the test IMP in comparison with the reference IMP and placebo. In this clinical trial the safety of the study drug (TIMP) will also be analyzed in comparison with the RIMP and also a placebo. Based on feasibility and bilateral discussions, OCT and the Sponsor have decided that the clinical sites for this study will be set in one of OCTs Baltic States Latvia. The total population enrolled for this clinical study is 70 patients, who will be separated in 5 different sites throughout Latvia. The enrollment period planned to be implemented equals one quartal during the spring months. Thechoice of sites has been made based on previous experience with these institutions, quality and timelines of enrollment and investigations. There are many different aspects of a clinical trial that must be considered when deciding where and when to run a clinical trial. OCT does a thorough job in assuring that everybody and everything is where and when it should be located on time and in the right place for a clinical trial to run and operate effectively.

OCT has had previous experience in this clinical research field of sore throat studies and other respiratory / lung diseases, rhinitis, bronchitis, stable angina, etc.. Very similar sore throat studies were Phase II and III with multi-site operations in Russia and some other countries. OCT is very pleased to have the chance to run this clinical trial for this Sponsor. OCT hopes that this project will result in future collaboration with this same Sponsor in the future after a successful clinical trial.