New studies demonstrate efficacy of novel Lipoxin analog in laboratory models of Crohn's disease

Berlex announced today that new laboratory results demonstrate that its modified version of the naturally occurring lipoxin molecule exerts potent anti-inflammatory and immunomodulatory effects in Crohn's disease in vivo models and may provide a promising new oral treatment.

"Our goal is to advance new therapeutic options that focus on restoring normal immune function rather than suppressing the immune system," said Joachim-Friedrich Kapp, M.D., head of global specialty therapeutics business unit for the German parent company of Berlex. "The lipoxin analog is another step in our development program to broaden the therapeutic options for Crohn's patients."

The laboratory findings appear in this week's edition of the Proceedings of the National Academy of Sciences.

"Over the past decade, we have led a global effort to explore the anti- inflammatory and immunomodulatory role of lipoxins in immune diseases," said Daniel Perez, M.D., president of Berlex Biosciences, the company's research center in Richmond, CA. "John Parkinson, Ph.D., and his collaborators at academic institutions around the world have expanded our understanding of the role of lipoxin -- a naturally occurring molecule in the body -- and the therapeutic potential of chemically modified versions of this natural molecule in many different inflammatory conditions."

The team used a colitis model that mimics Crohn's disease and responds to current Crohn's therapies such as 5-aminosalicyclic acid, corticosteroids and anti-TNF-alpha antibodies. Improvements in colitis symptoms -- weight loss, colon injury and mucosal inflammation -- for the oral lipoxin analog were similar to published findings for injectible anti-cytokine therapies and equal to oral prednisolone in a head-to-head pre-clinical comparison. The lipoxin analog both prevented and treated colitis -- suggesting potential use in induction of remission and/or maintenance therapy in Crohn's disease.

Evolving research suggests that the primary defect in Crohn's disease may be a breakdown in the layers of mucosal barrier protecting the gastrointestinal tract. Analyses of the lipoxin analog's mechanism of action revealed a novel role for lipoxins in blocking the cellular cascade of dysfunctional immune responses that leads to inflammation in the mucosal lining of the gastrointestinal tract.

"We are committed to expanding the therapeutic options available to the more than 1 million Crohn's disease patients worldwide," said Kapp. "Our lead candidate, LEUKINE(R) (sargramostim), is being evaluated in a comprehensive, worldwide clinical trials program as a potential new treatment for Crohn's disease. It is exciting to have a follow-on therapeutic in pre-clinical development which seeks to exploit a natural pathway for reversing inflammation by blocking the overactive secondary, or adaptive, immune responses found in Crohn's disease."