Trial Testing Immunotherapy as Gout Treatment

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An early-stage clinical trial aims to test an immunotherapy treatment that may effectively treat severe gout without unwanted immune responses.

The trial is being conducted by Selecta Biosciences, a biotechnology company.

The biologic therapy combines a form of uricase with polyethylene glycol. Uricase is an enzyme found in some animal species that oxidizes uric acid to make it more soluble. However, uricase also causes an immune system reaction. To combat this, the researchers combined it with polyethylene glycol, which does not cause immune reactions and improves the actions of biologic drugs.

The combination agent, called pegsiticase, is delivered via the company’s synthetic vaccine particle system in a therapy currently code-named SEL-212. In the synthetic vaccine particle system, biodegradable nanoparticles are generated to direct the immune system and suppress immune responses to specific antigens.

With this trial, the company is aiming to determine safe and effective treatment doses. Each participant will receive a single dose of pegsiticase through intravenous infusion. The doses will vary in strength so the researchers can assess the efficacy of different doses. To determine safety, the researchers will track any adverse reactions in the 30 days after the treatment. Additionally, they will measure changes in uric acid levels and formation of anti-drug antibodies that indicate an adverse immune reaction.

The trial will take place in two locations: Altoona, Pa. and Dallas. They are recruiting 25 participants who have high uric acid levels.

10 June 2015. An early-stage clinical trial is recruiting patients to test the safety of a treatment for severe gout that harnesses the immune system, but still avoids unwanted immune responses. The trial is conducted by the biotechnology company Selecta Biosciences at two sites in the U.S.: Altoona, Pennsylvania and Dallas, Texas.

Gout is a complex form of arthritis, marked by sudden and severe episodes of pain, with tenderness and redness in the joints, particularly at the base of the big toe. Men tend to be affected more than women, but women become more susceptible to gout after menopause. Gout occurs when uric acid builds up and forms needle-like crystals called tophi in the joints or surrounding tissue, causing the pain and inflammation. The company cites data estimating gout affecting 4.7 million people in the U.S.

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