05.Oct.2012

Alcoholism and Chronic fatigue syndrome are two local phase I clinical studies

CFS also known as chronic fatigue syndrome or myalgic encephalomyelitis (ME) is a problem throughout the whole world and is often not properly diagnosed, and can occur at any age even as early in children as 5 years old.

OCT is very content with the progression of a couple of Phase I clinical studies which are currently being conducted in Russia. CFS also known as chronic fatigue syndrome or myalgic encephalomyelitis (ME) is a problem throughout the whole world and is often not properly diagnosed, and can occur at any age even as early in children as 5 years old. The main symptom of CFS is severe fatigue or exhaustion following mental or physical activity of some sort. There are also other symptoms which are present in CFS such as muscular pain, sore throat, insomnia, stomach pain, painful lymph nodes, sensitivity to light, and short term memory loss. These will not all be present in all cases of CFS, but sometimes there will be multiple ones for certain individuals who have very severe cases. The other Phase I clinical study is being conducted on an anti-alcoholic medicine. Alcoholism is a very dangerous disease worldwide which cause about 2.5 million deaths annually. Among young people aged from 15-29 more than 320,000 die from alcohol related causes, which results in almost 10% of the total deaths in this age bracket.

OCT is running two similar designs Phase I clinical studies one which is related to CFS and the other is related to the anti-alcoholic medicine. Both of these clinical trials are being locally run here in Russia at the same site. The one associated with fatigue has a total patient populationenrollment of 32, while the one related to alcohol has 24 patients enrolled. The clinical trial associated with CFS is investigating the safety and tolerability of the new molecule for chronic fatigue syndrome (CFS) in healthy volunteers. The alcohol related clinical trial is also running their design in the same manner in which the CFS is in terms of measuring safety and tolerability in healthy volunteers. The first 2 groups were enrolled for both of these Phase I clinical studies and finished the study protocol in May and July, the 3rd group recently finished the therapy and will finish the follow-up in September. The latest group will only be enrolled in September and then will begin the clinical study.

OCT has not had previous experience in both of these therapeutic areas of study in the past, which is why OCT was so excited for this clinical study with this Sponsor. This is the first project with this Sponsor conducting this clinical study in Russia, but OCT hopes that this will become a consistent client for future clinical trials or other services which OCT provides.