Celiac Disease and Gluten-Free Diet Support
- Questions? Join our forum: Nearly 1 MILLION POSTS, and over 62,000 MEMBERS!
Follow / Share
|Get Email Alerts|
- Safe Gluten-Free Food List (Safe Ingredients)
- Unsafe Gluten-Free Food List (Unsafe Ingredients)
- Gluten-Free Alcoholic Beverages
- Celiac Disease Symptoms
- The Gluten-Free Diet 101 - A Beginner's Guide to Going Gluten-Free
- Interpretation of Celiac Disease Blood Test Results
- Is Buckwheat Flour Really Gluten-Free?
BL-710 Wins Designation as EU Medical Device for Celiac Treatment
Celiac.com 02/04/2016 - BL-7010, a non-absorbable, orally available co-polymer for the treatment of celiac disease, has received designation as Class IIb medical device in the European Union, according to manufacturer BioLineRx Ltd.
This designation clears path for BioLine’s BL-7010 program, and allows the company to plan the next steps in the development of a commercial version of BL-7010.
BL-7010 shows a high affinity for gliadins, the proteins in gluten that trigger celiac disease. BL-710 works by sequestering gliadins, effectively masking them from enzymatic breakdown, and blocks the formation of immunogenic peptides that trigger the adverse immune reactions in people with celiac disease. This results in a significantly reduced immune response triggered by gluten. Together with the gluten, BL-7010 passes harmlessly through the digestive tract and is not absorbed into the blood.
The safety and efficacy of BL-7010 have been demonstrated in a number of pre-clinical studies, including a Phase 1/2 study completed in November 2014.
In prepared comments, BioLineRX CEO Kinneret Savitsky, Ph.D., said that the company is "excited to receive confirmation for the medical device designation pathway in Europe for our BL-7010 program," and is now planning the next steps in the development of this product, including the next clinical efficacy study which we expect to commence in mid-2016."
The company also continues to "evaluate the potential of BL-7010 as a food supplement," said Dr. Savitsky.
Read more at: PRNewswire.
Celiac.com welcomes your comments below (registration is NOT required).
Could Egg Yolks Hold the Key to Celiac Disease Treatment?
There are numerous pills, enzymes, and other products in development that are all designed to provide moderate protection against accidental gluten exposure to people with celiac disease to gluten-intolerance.... [READ MORE]
How Close Are New Celiac Disease Treatments?
Of course, a strict gluten free diet is still the only safe and effective treatment for celiac disease.... [READ MORE]
The Top Ten Physical Complaints from Celiac Patients
Most people with celiac disease suffer from classic symptoms like weight-loss and diarrhea before diagnosis, right? Wrong.... [READ MORE]
Can Steroids Help Treat Celiac Disease?
A research team recently examined the effects of prednisolone and a gluten-free diet on mucosal epithelial cell regeneration and apoptosis in celiac disease.... [READ MORE]
Jefferson Adams is a freelance writer living in San Francisco. His poems, essays and photographs have appeared in Antioch Review, Blue Mesa Review, CALIBAN, Hayden's Ferry Review, Huffington Post, the Mississippi Review, and Slate among others.
He is a member of both the National Writers Union, the International Federation of Journalists, and covers San Francisco Health News for Examiner.com.View all articles by Jefferson Adams
In Celiac.com's Forum Now:
Celiac.com Celiac Disease & Gluten-Free Diet Forum - All Activity