OCT will conduct additional pre-clinical studies and a bioequivalence trial of an oncology drug for an integrated healthcare multinational company.
Certain additional pre-clinical data should be obtained prior to the initialization of the bioequivalence trial, namely, the results of acute and sub-acute toxicity studies. This usually takes no more than 2,5 - 3 months, including the import of the drug, studies themselves, report preparation, etc. These studies are usually conducted on mice and rats. The primary goal of acute and sub-acute toxicity study is to obtain data on the toxicity of the new generic product. These data will be later included into the registration dossier and submitted to regulatory authorities for their review before the bioequivalence study is launched.
After these activities have been completed, OCT will initiate the bioequivalence study, in which OCT will be responsible for all the activities: logistics issues, documents design, review and translation, clinical trials application and regulatory authorities approval, conduct of the clinical part and analytical services, clinical data management, statistical analysis, and final report preparation.
The investigational product is a drug used for the treatment of certain cancer forms. It acts by inhibiting a certain enzyme in cancer cells (and not destroying all cells, which divide quickly). The drug is usually used in the treatment of the following diseases - gastrointestinal stromal tumors, chronic myelogenous leukemia and other cancers. It can also be used in aggressive systemic mastocytosis without c-Kit mutational status or with c-Kit mutational status unknown, relapsed or refractory Ph-positive ALL, etc.
The purpose of the trials is to obtain the drug registration in the Russian Federation. Chronic myelogenous leukemia is one of the most widespread leukosis among adults. There are more than 14 000 patients in Russia diagnosed with this diseases, and, unfortunately, this figure adds roughly 3 000 new cases each year. Average age of such patients is 55. The access of leukemia and patients to new drugs and therapies with proved efficacy should help resist the disease and try to improve patients` quality of life.