RESEARCH STUDIES: Index

MetaHIT FP7 European Research Project Research 2008 – 11 [Click Here]

EFCCA - results of first EFCCA Pan European IBD Patients Study [Click Here]

IFPMA - Clinical trials portal [Click Here]

Traficet - EN CCX282B oral investigational study in Crohn's disease [Click Here]

EFCCA Note: Patients should also consult their Physicians.

MetaHIT FP7 European Research Project Research 2008 – 11

Metagenomics of the Human Intestinal Tract - www.metahit.eu

EFCCA provided early IBD patient perspective support to this successful EC research project grant application where multi-year funding by the European Commission has enabled this innovative human metagenome project to go ahead. We are pleased to report that the later phase of the project programme will include studying the correlation between microbiota and inflammatory bowel disease.

One of the strategic objectives of the project is to place Europe in a leading position within the international community towards the characterisation of the human microbial metagenome (i.e. the combined genomes of all dominant microbes associated with the human body). Although the 4 year project is being managed from the French Agricultural Research Institute - INRA at Jouy-en -Josas, France, a wide-range of partners from both within Europe and other parts of the world will be involved in the extended programme.

MetaHIT is focusing on the intestines because of both the high density and variability of its microbial content and the major role played by the gut in the preservation of health and well being, but conversely as a trigger for a wide range of chronic diseases. Complex study/work programmes will include: association/sequencing, diagnostic metagenomic methodologies, database specification, new data mining software and the correlation between microbiota and human health status.

EFCCA welcomes this research, which will investigate the role of the metagenomes (those inside a range of gut bacteria including IBD). There is a need to have a better understanding of the relationship between Crohn's disease and ulcerative colitis (IBD) and the gut flora.

The pilot IBD study will be undertaken at the Vall d'Hebron Hospital in Barcelona, Spain later in the programme. While IBD often leads to severe weight loss, the project will also include a weight gain study associated with the increasing problems of obesity. The Obesity work will be undertaken in Denmark.

EFCCA is pleased to have the opportunity to be involved in this project, which will provide researchers with many challenges. We are grateful to INRA for allowing us to use the project logo and some pictures (© INRA/Bertrand Nicolas) to support this announcement.

Please visit the MetaHit official website at: www.metahit.eu for full details and regular updates about the 4 year (2008 - 2011) European Commission funded research project.

  [Back to the index]

Traficet – EN : Clinical Development of CCX282-B for Crohn’s Disease

CCX282-B is a first-in-class oral anti-inflammatory investigational therapeutic for the treatment of inflammatory bowel disease (IBD), which is currently in clinical development for Crohn's disease. As of October 2006, more than 200 patients have received CCX282-B in various clinical trials.

About the CCX282-B Crohn’s Disease Trial (CL004_282)

A PHASE II/III clinical trial in patients with moderate to severe Crohn’s disease (CL004_282) is ongoing in many countries and centers around the world, including Europe, where the study is ongoing in Austria, Belgium, Bulgaria, Czech Republic, Denmark, France, Germany, Hungary, The Netherlands, Poland, Sweden and the UK. The trial in which CCX282-B is being evaluated is designed to find out how effective and safe the drug is in comparison to taking placebo. Both men and women, age 18 years or older and who are experiencing worsening of their Crohn’s Disease, are eligible to enroll, subject also to the following inclusion and exclusion criteria.

Key Inclusion Criteria for this trial are:

• moderate to severe Crohn's Disease
• CDAI 250-450
• CRP >7.5
• signed written informed consent

Key Exclusion Criteria for this trial are:

• >100 cm of small bowel resected
• ileostomy, colostomy or rectal pouch
• diagnosis of ulcerative colitis or indeterminate colitis
• evidence of short bowel syndrome requiring enteral or parenteral supplementation or total parenteral nutrition
• hepatitis B, C or HIV infection
• infection in the past that required treatment with intravenous antibiotics
• serious or GI infection in the previous 12 weeks
• TNF inhibitor therapy in the previous 12 weeks; however, stable doses of other therapies, i.e., azathioprine, 6-mercaptopurine, glucocorticoids up to 20 mg prednisone-equivalent, are allowed)

The trial will enroll approximately 420 patients for a trial duration of 12 months. A list of clinical study sites can be found at: www.clinicaltrials.gov (Study Identifier: NCT00306215).

About CCX282-B

CCX282-B is an experimental drug that works by reducing the movement of certain immune cells from the blood stream into the gut wall and may help to dampen the chronic inflammatory process in Crohn’s disease, through specifically targeting a chemokine receptor CCR9, which is involved in migration of T cells to the digestive tract.
There are currently no drugs licensed for use in Crohn’s disease that have been developed to specifically block such cell movement: CCX282-B is the first drug to be evaluated in this new category. The drug, can be taken by mouth as a capsule

Clinical Trial Results To-Date

Across four Phase 1 trials, with a total of 145 subjects, CCX282-B has been well tolerated.
Earlier in 2006, ChemoCentryx completed a Phase 2 clinical trial with CCX282-B administered daily for 28 days compared to placebo. This trial was a double-blind, placebo-controlled trial to evaluate the safety, tolerability, and clinical activity of CCX282-B in subjects with active, moderate to severe Crohn's disease. The drug was well tolerated and demonstrated clinical activity compared to placebo in subjects with elevated CRP and/or CDAI scores. Results from the “Traficet-EN” trial were presented at the October 2006 United European Gastroenterology Week (UEGW) meeting in Berlin.

As shown above more information about Traficet – EN and the studies are available at: www.clinicaltrials.gov and at: www.chemocentryx.com

[Back to the index]

EFCCA Pan European IBD Patients Questionnaire 2005
For information about this survey and the results from the > 5600 completed IBD survey forms from Crohn's and colitis patient members in 7 of the EFCCA member association countries ( Denmark, Italy, The Netherlands, Portugal, Spain, Switzerland and the United Kingdom) go to the What's New page and scroll down. There you will also find related downloadable documents.

[Back to the index]

IFPMA - the International Federation of Pharmaceutical Manufacturers Associations has launched a second stage of their Clinical Trials Portal.
The Portal, which contains information on ongoing and completed clinical trials from the research-based pharmaceutical industry, is also available in German, French, Japanese and Spanish as well as English. For more info go to: www.ifpma.org/clinicaltrials

[Back to the index]