The primary objective of the study is to assess the safety of single and repeated ascending doses of BL-7010 in well-controlled celiac patients. Secondary objectives include an assessment of the systemic exposure, if any, of BL-7010 in the study patients. “The commencement of BL-7010’s Phase 1/2 study in a world-leading celiac treatment center is an important milestone in the development of one of our most promising projects,” said Dr. Kinneret Savitsky, Chief Executive Officer of BioLineRx. "Based on our pre-clinical results to date, we are very enthusiastic about this unique product, which is also generating a lot of excitement from both the scientific and medical communities.Celiac disease is an autoimmune condition that causes damage to the small intestine, and is associated with other autoimmune disorders, as well as with osteoporosis, infertility, neurological conditions and even cancer. Although 1% of the world’s population suffers from this disease, there are currently no approved celiac therapeutics, and the only treatment available today is a gluten-free diet that is exceptionally difficult and costly to maintain. In addition, there are an extremely small number of clinical-stage projects under development worldwide for celiac disease, which we see as a significant opportunity for our product." Dr. Savitsky concluded, “We anticipate 2014 to be a significant year for BioLineRx marked by several important milestones across our clinical-stage development programs, among which we are now pleased to include BL-7010.We are looking forward to the results of this Phase 1/2 safety study, expected in mid-2014, to be followed by an efficacy study that we hope to commence in the second half of 2014." About BL-7010 BL-7010 is a novel, non-absorbable, orally available polymer intended for the treatment of celiac disease.It has a high affinity for gliadins, the immunogenic proteins present in gluten that cause celiac disease. By sequestering gliadins, BL-7010 effectively masks them from enzymatic degradation and prevents the formation of immunogenic peptides that trigger the immune system. BL-7010 is excreted with gliadin from the digestive tract, preventing the absorption of gliadin into the blood. This significantly reduces the immune response triggered by gluten.
Going gluten free may not be enough to manage celiac disease
While the growing availability of gluten-free products available in stores may make it easier to manage these symptoms, is a gluten-free diet enough to make symptoms go away? Contrary to popular belief, celiac disease is more than just an upset stomach. Celiac disease is an autoimmune disease that can impair the ability of the body to absorb necessary nutrients which can lead to other health problems like anemia, weight loss, depression, osteoporosis, infertility, lymphoma and dental issues. It is often difficult to diagnose, because the symptoms can be similar to those caused by irritable bowel syndrome, Crohns disease, intestinal infections, lactose intolerance and depression, and each person experiences symptoms in a different way. Blood tests are the first step in a diagnosis of celiac disease. The Food and Drug Administration established regulations in August that defines gluten-free for product manufacturers. The label gluten-free can be placed on any products that contain less than 20 parts per million of gluten. However, even those who carefully choose their foods based on gluten-free labels also need to be aware of cross-contamination dangers, both at home and in the community. For example, if a cutting board is used to chop bread and vegetables without a thorough washing in-between, a person with celiac disease eating the vegetables could eat enough gluten to cause symptoms and/or injury to the small intestine. For many people, completely eliminating gluten from their diet isnt enough to alleviate all of their celiac disease symptoms or allow for complete healing of the intestinal damage caused by small amounts of gluten in the diet. About 60 percent of patients still experience moderate to severe symptoms of their disease while following a gluten-free diet, according to a recent study. The CeliAction Study is a clinical research study that will determine if an investigational drug is able to improve the damage in the lining of the intestine caused by even the smallest trace of gluten. The study will also evaluate whether the investigational drug improves any symptoms of celiac disease.
Gluten Free Diet Not Just for Celiac Disease
A simple diet of unprocessed fruits, vegetables, and protein sources such as legumes, fish and meat is naturally gluten free and casein free. Eating nutritious whole foods is healthier than eating processed foods. If packaged foods are purchased, reading and knowing ingredients on food labels is a must. Milk ingredients and gluten ingredients are hidden in many foods. Consult a Medical Professional Before Going Gluten Free Only a medical professional can give medical advice, and it is always best to consult a medical practitioner such as a doctor prior to making any changes in diet or exercise. Suite101.com, while making every effort to present accurate information, is not a source of medical advice. Going gluten free before consulting a doctor is not advisable for those who want a medical diagnosis. Some sources, such as the American Diabetes Association article mentioned above, say that trying a gluten free diet might help to convince a doctor (that a patient has celiac disease), but consulting a professional prior to making dietary changes is especially important if celiac disease, wheat allergy, gluten allergy, or gluten intolerance is suspected. Why? Staff at the Mayo Clinic say that cutting gluten and/or casein before being tested can invalidate the medical test results. Antibodies and intestinal damage can only be detected when a person has been eating the offending foods.