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news.Protea Biosciences has concluded a randomized, placebo-controlled, parallel designed Phase I/II clinical trial of MS1819 recombinant Lipase in partnership with an European pharmaceutical company, Mayoly-Spindler.
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The trial was designed to investigate the safety profile of MS1819 and to get early evidence of the clinical activity of the MS1819 recombinant lipase in patients who were suffering from malabsorption syndrome due to exocrine pancreatic insufficiency resulting from chronic pancreatitis.
As per the terms of the agreement, Mayoly-Spindler has licensed marketing rights of the drug to Protea in North America.
Both the companies intend to start the Phase II trial in 2012.
Protea CEO Steve Turner said the study results are fully in accordance with their expectations.
"The completion of our first clinical trial is an important milestone for this promising drug, as well as for Protea," Turner said.