Full-Service Clinical Trials in Central and Eastern Europe

OCT have initiated activities in relation to an single dose two-way crossover clinical study of the study formulation compared to capsules in healthy male subjects. The study will be performed in a phase I unit in Russia.

The investigational product will be used for the treatment of benign prostatic hyperplasia.

Usually, if this disease is not treated in a right way it can cause risks of urine flow obturation, and consequently may lead to the need for surgery. Benign Hypertrophic Prostate (BHP) is considered a benign neoplasm, it does not metastasize. However, the tumour can grow in size and, in this way, bring problems with urination processes compressing the male urethra.

BHP is one of the most widely spread indication in urology. According to statistics, every second man after 50 suffers from BHP. It is considered that this medical condition is progressing in about 85% of men.

Among clinical complications in relation to BHP are such as erythrocyturia (in other words, blood in urine). When urine pressure in bladder increases veins may be harmed, which leads to bleeding. Another medical complication is bladder calculi, which appear as a result of urine congestion in the bladder.

It is advisable for men after 50 to have urologist examination and corresponding procedures done every half a year in order to diagnose the disease, if any, in due time and take the appropriate measures.

OCT will be responsible for the major activities in the study including documents design, project management, clinical monitoring, interaction with the clinical facility and the analytical laboratory, data management, final report preparation.

OCT is participating in ovarian cancer trial.

This is FDA controlled study conducted in 86 sites around the world. OCT is responsible for sites in Russia, Ukraine, Belarus, Latvia, Lithuania, Estonia and Bulgaria. In total, our CRO is responsible for more than 60 oncology sites across Eastern Europe.75 % of all patients were enrolled in OCT countries. So we can definitely say that the region where our CRO operates is one of the high recruiting countries in the world.

The clinical study is conducted in patients with recurrent epithelian cancer, primary peritoneal cancer or fallopian tube cancer.
At the end of 2011, successful database lock was performed. We are very pleased to meet this important milestone for our client’s clinical development program. In this study we are responsible for

• Clinical Monitoring
• Project Management
• Regulatory
• Clinical Supply Management
• Quality Assurance Services

We will continue to support our client’s clinical program to defeat ovarian cancer. Patients’ enrollment will continue until 650 patients are enrolled.

Ovarian cancer is a disease with few and unspecific symptoms at its early stages, therefore difficult to detect. Unlike certain other cancer diseases the number of patients diagnosed with ovarian cancer increases every year. Ovarian cancer is most often diagnosed in women over 50 years of age, but younger women are also affected. The annual incidence of new diagnosed cases is approximately 125 000 women in EU alone.

OCT is launching a phase IIb/III clinical study in arthritis patients

OCT is preparing for a phase IIb/III clinical trial in patients with rheumatoid and psoriatic arthritis. This will be a multi-center clinical study of efficacy, safety and pharmacodynamics of the investigational product. There will be about 150 patients with the both indication entered in the study.

Psoriatic arthritis affects 5-7% of patients diagnosed with psoriasis. 70% of patients suffer from the joint syndrome after skin reactions of psoriasis, in 15-20% of patients the syndrome develops before skin reactions, and 10% of patients have the both symptoms at the same time.

Rheumatoid arthritis is a chronic autoimmune systemic inflammatory disease of conjunctive tissue, which usually affects joints in the way of erosion-destructive progressing polyarthritis. About 1% of population suffer from this disease. In the world, there are almost 60 mln. RA cases.

In order to recruit patients for this clinical study, OCT plan to have more than 15 sites. OCT have well-developed connections with the specialized clinics not only in St. Petersburg and Moscow, but also in remote cities in Russia, and OCT are going to initiate sites in several cities in Russia. The results of therapy, and efficacy of the drugs will be evaluated according to American College of Rheumatology scale, Disease Activity Score scale, and some other parameters.

OCT was awarded with a bioequivalence trial

OCT completed a phase I/II study in oncology

Clinical trial approval was received for phase II trial in pancreatic cancer

OCT have obtained two regulatory approvals for two phase I trials in healthy volunteers in Russia. The Sponsor is a new Russian biotechnology company with a portfolio of innovative drugs.

Each of the clinical trials will enroll volunteers in one phase I unit. Both clinical studies will be performed in groups of volunteers who will receive different doses of the IMP, starting from the lowest one. Possible adverse events will be closely monitored in each group after drug administration.

The first trial will be conducted for the medicinal product that is planned to be used as a treatment from chronic fatigue syndrome. There are different treatment schemes for patients suffering from the disease. The new product seems to be quite simple in terms of drug administration.

The second clinical study is planned with the newly developed drug that will in routine practice be used to treat chronic alcohol addiction.

The preceding pre-clinical studies of the products have expressed its effectiveness in animals. Supposedly, the results of the first-in-human studies for the two products will confirm its safety and effectiveness.
Qualification visits to the hospital have recently been performed in connection with the studies.

OCT is happy to announce that we have performed clinical trials application in Russia for a study in patients with gout. This is a registration study sponsored by one of our global clients. The study will be conducted by OCT at 10 sites in Russia and will enroll 200 patients within 5 month. All application documents have been prepared and submitted to the regulatory authority within one month. This will allow us to initiate clinical trial within 4 months after submission documents receipt from sponsor.

Gout is a form of arthritis caused by a buildup of uric acid also known as hyperuricemia.  People with gout either produce too much uric acid, or more commonly, their kidneys have a problem in removing it. High uric acid forms crystals in tissues. These uric acid crystals can accumulate in the joint and tissues around the joint over years.  When that happens, it can lead to inflammation that causes extremely painful gout attacks. Earlier research demonstrates that even though gout attacks typically resolve spontaneously within several days, the urate crystals remain in the joint and can lead to recurrent attacks. If left untreated, they can cause permanent damage to the joints.

The prevalence of gout appears to be increasing. It is currently estimated to be affecting over 5 million people in Russia. Gouty arthritis is most common in men over the age of 40. Nearly 90% all cases of gout affect men. Long-term treatment uses medications keeping uric acid level down at healthy level . Keeping the uric acid level low (less than 6 mg/dL) is the target for long-term management of gout.

This is the third study in arthritis conducted by OCT team. Our solid network of certified investigators around Russia is our guarantee of on-time patient enrollment in this study. OCT is working very closely with the sites in Russia to ensure recruitment goals are met and patient care and the quality of the data being collected is excellent.

OCT will provide the following services in this clinical study:

• Study Feasibility
• Project Management
• Clinical Monitoring
• Data Management and Statistics
• Regulatory Management
• Investigator Meeting
• Clinical Supply Management
• Quality Assurance Services
• Safety Management

TMF for phase II in a pain study was shipped to the sponsor

Trial approval was received for phase II trial in bladder cancer

Interim analysis has been completed on phase III trial in ovarian cancer, 75% of patients included in the IA were enrolled in OCT countries

Since 2007 OCT has been audited by external audits with the regularity of every other month. We are always happy to meet external auditors at our office. Fair and independent audit is beneficial to us in all respects. It is of extreme importance for the management of the company to have independent opinion regarding quality of our work and recommendations to improve.  For OCT it is very important because the company is growing very rapidly and today we are a company of 90 clinical trials professionals who are based in Russia, Ukraine, Belarus, Latvia, Lithuania, Estonia and Bulgaria.

In January 2012 OCT underwent auditing conducted by the representative of one of the global pharmaceutical companies. The systems review was conducted in two days and involved review of OCT SOPs, staff personal files inspection, staff interviews, facilities inspection and presentations of OCT clinical trials services. No major findings related to company’s Standard Operation Procedures (SOPs), quality assurance system, trials setup and startup, sites identification and initiation, study management of clinical trials, documents management, regulatory services, local IMP management system, Information technology and safety management for clinical trials were noted by the auditor. OCTs Director Clinical Operations and Quality Assurance Managers demonstrated excellent quality and process control, within predetermined budgets and scheduling parameters.

The auditor noted such advantages of OCT clinical trials management as close control of company executives, straight-forward quality assurance system,  simple and effective organizational structure, professionalism  and flexibility at every level. Each project OCT takes on is with the understanding that it must meet all regulatory requirements and must pass our internal compliance checks to ensure success. Obtaining good clinical data from investigative sites is achieved by having the best-trained, highly motivated and dedicated staff on board. Our responsive and experienced people take care of every detail, giving our clients total confidence that all CRO services will be provided by professionals in an efficient manner. Our flexible approach gives us the ability to bring together an outstanding team to meet any requirements.

OCT met an interim enrollment milestone of 50% of randomized patients in a phase II study of a novel drug to treat in Metastatic Breast Cancer.

Breast cancer is the second leading cause of cancer related death among women, according to the National Cancer Institute.  In 2010, NCI estimated that 207,090 women were diagnosed with breast cancer, while 39,840 women likely died from the disease.

According to official sources, worldwide, breast cancer comprises 22.9% of all cancers (excluding non-melanoma skin cancers) in women.  In 2008, breast cancer caused 458,503 deaths worldwide (13.7% of cancer deaths in women).
OCT client is sponsoring a controlled Phase II trial in metastatic breast cancer (MBC) subjects who have been previously treated with a taxane and an anthracycline.

Planned enrollment is 140 patients, 130 of them will be enrolled by OCT in Russia.  OCT has reached 50 % milestone in the study. The study is being performed in 15 Russian sites. The study is FDA controlled.   We are very pleased to see the progress in the trial and we hope that the study will lead to drug registration afterwards. OCT is working very closely with the sites in Russia to ensure recruitment goals are met, patient care and the quality of the data being collected is excellent.

We have provided the following services in this study:

• Clinical Monitoring
• Project Management
• Regulatory
• Investigator Meeting
• Clinical Supply Management
• Quality Assurance Services
• Study Feasibility
• Safety Management

OCT has been conducting clinical trials in breast cancer since 2006 in different countries of its operation: Russia, Belarus, Ukraine, Latvia, Lithuania, Estonia and Bulgaria. OCT is dedicated to innovative clinical cancer research.

OCT has very extensive experience in oncology:

• We have experience in the following indications:
• Breast cancer
• Prostate
• Bladder
• Bone Metastases
• NSCLC
• Colorectal
• Head Neck
• Ovarian
• Endometrial cancer

OCT has been granted with pregnancy registry study in patients with multiple sclerosis. This will be a multi-national study. OCT will be responsible for management of 2 centers in Ukraine.

Pregnancy registry is one of the methods to monitor product safety in pregnancy. Clinical trials exclude pregnant women; thus, little is known about the human teratogenic effect of a product at the time it first enters marketing. Multiple Sclerosis is more prevalent in women of childbearing age than in any other group. That’s why MS therapy manufacturers are more and more often required to make post-marketing commitments to conduct studies of the effects of products when used during pregnancy. The drug pregnancy registries are observational studies conducted by pharmaceutical companies to track the effects of certain prescription drugs on pregnancy outcomes when mothers have been exposed to drugs. Data collected on babies born to women taking a particular medicine are compared with babies of women not taking the medicine. These studies provide important information the effect medicines have on fetal development.

The purpose of this Multi-National pregnancy exposure registry in multiple sclerosis is to monitor, evaluate, and assess major and minor teratogenic effects in women exposed to a particular drug during pregnancy in routine clinical practice. The enrollment period for this pregnancy registry is 6 years. During this time we will obtain prospectively and systematically collected data on the potential pregnancy outcome and fetal effects associated with exposure to drugs during pregnancy.

Multiple Sclerosis (MS) is a chronic, immune-mediated disease of the central nervous system. It is caused by damage to the myelin, which forms the protective covering around nerve cells. When this covering is damaged, nerve impulses are slowed down or stopped. No one knows what causes MS. Globally, the median estimated incidence of MS is 2.5 per 100,000. Over 2 million people around the world have MS, including about 200000 Russians and about 20000 Ukrainians.

OCT is launching preparation activities for a multi-center phase I/II study in patients with myelosuppression caused by chemotherapy.

Myelosuppression is a process, under which the production of blood cells decreases. Normal blood contains many cells. These include white blood cells aimed at fighting infections and red blood cells, the function of which is to carry oxygen.

Myelosuppression is usually caused during cancer treatment, namely, chemotherapy. Many drugs used for chemotherapy may suppress the bone marrow for some time. X rays in therapy may also destroy. Myelosuppression can also be caused by cancer cells. Usually, the peak of myelosuppression occurs on day 7-14, and restoration – on day 21-28 after chemotherapy start.

The current study will be conducted in five groups of patients having neutropenia at a time of myelotoxic chemotherapy of breast cancer. 

OCT have broad experience in oncology studies, among which there are several big breast cancer trials. OCT also conducted a study in severe neutropenia in women with breast cancer. There were 9 sites in Russia and 5 sites in Bulgaria. This multinational study involved Russia, Poland, Latvia, Romania, Serbia, Hungary and Bulgaria. OCT team enrolled 156 patients in 2 countries in 6 months versus 123 patients in 5 other countries.

OCT experience in turns into such good aspects for the current trial as selecting qualified and experienced sites for the study with high recruitment rates.

At the same time, early-stage studies (namely, phase I and phase I/II) are considered to be the most risky in terms of possible effects (both positive and negative), especially if speaking about oncology studies. Often, such studies are conducted for patients in cohorts: the first cohort take the medicinal product in one dose, then, in case of no serious adverse reactions, the second cohort take the medicine in a slightly higher dose, etc. Safety boards can be organized in such studies in order to evaluate the impact of the drug on a patient before moving forward. SAE and SUSAR events, if any, are thoroughly monitored, controlled and tracked during such trials.