20.Dec.2012

OCT enrolls first three patients in a phase Ib-IIa HBV trial

The study Sponsor is a Russian company, resident of the biomedical cluster “Skolkovo” funded by the “RVK” company. The trial results are expected to be received and evaluated by the end of 2013.

OCT enrolls first three patients in a phase Ib-IIa HBV trial

The study Sponsor is a Russian company, resident of the biomedical cluster “Skolkovo” funded by the “RVK” company. The trial results are expected to be received and evaluated by the end of 2013.

Despite the global introduction of vaccination, chronic hepatitis B is still one of the unresolved problems of medicine. According to the WHO, over 2 billion People are carrying this virus. Out of those 2 billion, 400 million people suffer from the chronic hepatitis B. About 50 million of new HBV cases are being registered worldwide annually and about 2 million people die from this disease.

The study drug has a peptide structure which helps block the penetration of HBV inside the healthy hepatocytes (liver cells). This way the drug saves liver cells to recover liver tissue and prevent disease progression together from complications such as cirrhosis or liver cancer. This procedural mechanism of action may cure the disease after a shorter treatment cycle. Due to that fact the drug stands out compared to other anti-viral nucleids/nucleosides on the market which have to be taken lifelong. The drug has undergone preclinical trials in vitro and in vivo. The Phase l clinical trial in healthy volunteers was completed in Germany and has proven the drug’s safety and tolerability. OCT performed data management, statistical analysis, and prepared a final report for the phase l clinical trial.

In this phase ll clinical trial OCT will enroll 32 patients at 4 sites within a 3 month timeframe. Two backup sites were chosen to ensure on-time enrollment. This is a full-service support clinical project, including project managementsite selectionclinical monitoring, warehousing, study materials purchase and other logistics assistance, safety management, regulatory activities within the clinical trial approval and export/import licenses obtainment, final report preparation, investigator’s meeting organization, others. In addition OCT provides data management and final statistical report preparation services in this study. The leading international laboratory in Germany will be used for the assessment of the biosamples. The total study duration will be 16 months for this clinical trial