Hadassah

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.

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