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June 27, 2014

Med Page Today reports that atacicept did not meet primary endpoints in the Phase II/III trial. Flare rates were not significantly less in the group of patients treated at a lower 75 mg dose; while the rate was significantly lower for patients receiving a higher 150 mg dose, two deaths due to infections might have been associated with the drug.

The time to first flare (length of time person was in the study before experiencing a flare) was significantly longer among those treated with the 150 mg dose but not those who received the lower dose. Enrollment in the 150 mg dose arm was terminated prematurely due to the two deaths. Investigators feel the drug at the higher dose may still have benefit but further study is needed to determine if there is a role for atacicept in treating lupus.

Atacicept is a biologic agent that targets two B-cell factors being studied in patients with moderate-to-severe lupus. The study was reported on in Annals of the Rheumatic Diseases.- See more at: Lupus Research Institute.

June 11, 2014

The LRI launches Industry Council to facilitate active collaboration among companies, research leaders, and patient advocates to overcome common obstacles in developing new treatments for #lupus.

Learn more about the collaboration :http://www.lupusresearchinstitute.org/lupus-news/2014/06/10/lupus-research-institute-launches-industry-council-accelerate-new-treatments

December 17, 2012

Invion submitting Investigational Drug Application Early 2013

The Australian company Invion met with the U.S. Food and Drug Administration to discuss the roadmap for their drug INV103, and the FDA agreed to its proposed indication of systemic lupus erythematosus. The company will be submitting an Investigational New Drug Application early in 2013

INV103 is based on a naturally occurring protein, chaperonin10, which is present in all cells. It is thought to function as a natural regulator of the immune system. Administering the protein can help regulate inflammation,and can potentially be used to treat inflammatory diseases such as lupus.

See more at: Lupus Research Institute

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