OCT is happy to announce that it has initiated the first site in a very important study in Head and Neck Cancer patients. The study is performed at Russian sites. We plan to enroll 140 patients into the study. This clinical study will be performed at 20 sites across Russia. Other 19 sites are going to be initiated during February.
Oncology studies are usually the most difficult studies. However here at OCT we hope to complete the study on time. We plan that enrollment into the study will last for about 12 months.
OCT client is a leading Russian biotechnology companн. It is the second trial we perform for this client.
Study start-up was a challenging task for OCT. It required OCT to develop study design which would satisfy regulatory experts. As we know, in Russia often refusal to perform a clinical trial is connected with the wrong study design, choice of study population, duration, treatment regime or some other factors. This is due to the fact that in Russia there are no relevant guidance on pre-clinical and clinical programs for certain classes of drugs such as biosimilars. Currently in Russia there are no manuals to develop such drugs. The Russian legislation does not give a definition to biosimilars as well. There are no regulatory requirements, for preclinical and clinical trials which need to be conducted in order to be approved for marketing by the Russian ministry of Health. Thus, while getting ready for the trial, OCT became an expert in developing study Protocols for biosimilar drugs.
OCT is looking forward to starting study enrollment into the studies. OCT is providing full service to this client.
The magnitude of the problem of head and neck cancer is really high. It is the fifth most common malignancy worldwide. It is considered that tobacco and alcohol are the primary etiologic agents in these cancers, suggesting prevention should be a primary public health goal in the field. Smoking and drinking are the major risk factors, especially in Russia, Central and Eastern Europe. The huge increase in head and neck cancers is cause for great concern, particularly in Russia and Central-Eastern Europe. The great majority of these cancers could be prevented by reducing the prevalence of established risk factors.