Full-Service Clinical Trials in Central and Eastern Europe

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 received regulatory approval for two phase I trials in healthy volunteers

CTA for phase II study in gout was performed in Russia

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.

OCT launches a multicentre phase IIA/III study of a novel biological agent to treat anemia in chronic kidney disease including 120 subjects in Russia. Total 8 sites will be initiated. Our medical writers are in the process of study documents design and study is being prepared for startup. We have everything necessary to get this study started quickly and efficiently including a skilled research team, experienced investigators and an extensive recruitment list. A central laboratory will be used to evaluate the safety and efficacy of the study drug.

Chronic kidney disease is a progressive loss of kidney function during a period of months or years that can be caused by a number of conditions, such as diabetes and high blood pressure. It is a highly prevalent condition worldwide with numbers expected to rise over the next decade. CKD affects more than 20 million people in Russia and millions more in the rest of the world.

Anemia is a frequent complication of chronic kidney disease. Studies have shown that anemia is associated with an increased risk of mortality and cardiovascular morbidity in CKD patients. The optimal treatment of anemia in patients with CKD is of increasing importance, since early and adequate treatment of anemia may have a positive impact on mortality in this patient population.
In nature, the amount of oxygen in the blood determines how fast red cells are produced. Low oxygen level in kidney cells stimulates the genes inside their center to synthesize the hormone (erythropoietin) necessary to turn on the bone marrow so it can produce red blood cells. As the kidney becomes diseased, mechanisms that form scar tissue take over, and cells responsible for manufacturing erythropoietin die. Usually anemia starts in the third stage of kidney disease worsening as kidney disease progresses. In most cases, the cause of anemia in kidney disease is the result of decreased production of erythropoietin. Once the diagnosis of anemia in chronic kidney disease is made, the therapy includes injections of the synthetic form of erythropoietin.

OCTs wide network of investigative sites specialized in the nephrology therapy area, and close relationships with these sites provides us with confidence that study is to be completed on time and within the budget.