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Hadassah-Developed Autoimmune Disease Drug Proves Safe in Phase I Clinical Trial

Thursday, Aug 6 2015

A drug developed at the Hadassah Medical Organization to help modulate the effects of autoimmune diseases such as rheumatoid arthritis has proven safe in a Phase I clinical trial at Hadassah. Manufactured by Protalix BioTherapeutics of Carmiel, Israel, the drug, PRX-106, proved to activate T cells, which have a central role in maintaining a well-functioning immune system.

"The results are very exciting and encouraging,” reports Prof. Yaron Ilan of Hadassah’s Internal Medicine Department A and a specialist in immunology and liver disease. “PRX-106 has the potential to be an effective agent for numerous immune-mediated disorders."

This Phase I trial tested the safety and tolerability of PRX-106 in healthy volunteers. With three separate cohorts receiving different doses of the protein compound for five consecutive days, the results demonstrated that oral administration of PRX-106 is safe and well tolerated in all three doses. In addition, researchers observed that PRX-106 triggered the action of various subsets of T cells, some of which are correlated with an anti-inflammatory response.

Preclinical studies with PRX-106 proved to alleviate both immune-mediated hepatitis and colitis in a mouse model, enhancing serum levels of regulatory T-cells and significantly improving clinical arthritis parameters, such as joint inflammation, swelling, and tissue degradation.

PRX-106 uses plant cells as a natural capsule for this protein compound. Protaliz anticipates that it will initiate the next phase of clinical trials with patients at the end of the year.

Comments

From: Gila on September 10, 2015
Would this drug also be one that could be effective in treating Crohn's Disease patients? As is now true of the RA drugs that work with T cells and the autoimmune system? Which I now inject....the oral/pill form sounds much more tolerable considering my Dr. says I will need to continue my therapy for life!
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