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Biolinerx Enters Clinic With Novel Treatment For Celiac Disease - Pr Newswire (Press Release)


Scott Adams

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PR Newswire (press release)

"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 ...

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pricklypear1971 Community Regular

In 'up to 32 patients'.

Thirty two?????

"The Phase 1/2 study is a two-part (single and repeated), double-blind, placebo-controlled, dose escalation study of BL-7010 in up to 32 patients. 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."

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    • xxnonamexx
      What about digestive enzymes that I hear help? I take align 5x probiotics daily.
    • Samanthaeileen1
      thank you RMJ! That is very helpful advice. Good to know we aren’t crazy if we don’t do the endoscopy. We are going to try the gluten free and see how symptoms and levels improve.    thank you Wheatwacked (love the username lol) that is also reassuring. Thankfully she has an amazing and experienced pediatrician. And yesss I forgot to mention the poop! She has the weirdest poop issues.    How long did it take y'all to start seeing improvement in symptoms? 
    • Wheatwacked
      My son was diagnosed when he was weaned in 1976 after several endoscopies.  Given your two year old's symptoms and your family history and your pediatrition advocating for the dx, I would agree.  Whether an endoscopy is positive or negative is irrelevant.   That may happen even with endoscopy.  Pick your doctors with that in mind. In the end you save the potential trauma of the endoscopy for your baby.   Mine also had really nasty poop.  His doctor started him on Nutramigen Infant because at the time it was the only product that was hypo allergenic and had complete nutrition. The improvement was immediate.
    • RMJ
      So her tissue transglutaminase antibody is almost 4x the upper end of the normal range - likely a real result. The other things you can do besides an endoscopy would be: 1.  Genetic testing.  Unfortunately a large proportion of the population has genes permissive for celiac disease, but only a small proportion of those with the genes have it. With family history it is likely she has the genes. 2.  Try a gluten free diet and see if the symptoms go away AND the antibody levels return to normal. (This is what I would do). Endoscopies aren’t always accurate in patients as young as your daughter. Unfortunately, without an endoscopy, some doctor later in her life may question whether she really has celiac disease or not, and you’ll need to be a fierce mama bear to defend the diagnosis! Be sure you have a good written record of her current pediatrician’s diagnosis. Doing a gluten challenge for an endoscopy later in life could cause a very uncomfortable level of symptoms.   Having yourself, your husband and your son tested would be a great idea.  
    • Samanthaeileen1
      here are the lab ranges.  Normal ranges for tissue transglutaminase are: <15.0 Antibody not detected > or = 15.0 Antibody detected normal for endomysial antibody is < 1.5. So she is barely positive but still positive. 
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