MORGANTOWN, W. Va., May 26, 2011 (GLOBE NEWSWIRE) -- Protea Biosciences, a leading developer of new technology for pharmaceutical research, announced today that the company, in partnership with Mayoly-Spindler, a European pharmaceutical company, has successfully completed a Phase I/IIA human clinical trial for their MS1819 recombinant Lipase.
The clinical trial was a randomized, placebo-controlled, parallel design conducted at Hospital la Timone in Marseille, France. The goal of the clinical trial was primarily to assess the safety profile and secondarily, to get early evidence of the clinical activity of the MS1819 recombinant lipase in patients with malabsorption syndrome due to exocrine pancreatic insufficiency resulting from chronic pancreatitis.
"The study results are fully in accordance with our expectations," stated Steve Turner, Protea's CEO. "The completion of our first clinical trial is an important milestone for this promising drug, as well as for Protea."
Lipase is an enzyme that is produced by the pancreas to digest fat. Chronic pancreatitis is defined as long term inflammation of the pancreas, characterized by irreversible changes in pancreatic cells. Causes of exocrine pancreatitis insufficiency (EPI) include cystic fibrosis, drug/alcohol abuse, pancreatic cancer and other conditions. Chronic pancreatitis causes chronic abdominal pain, impairment of hormone and digestive enzyme functions of the pancreas, and can produce serious weight loss. A lack of pancreatic enzymes results in the inability to properly digest food leading to malnutrition. Vitamin absorption (A, D, E, and K) is also impaired.
"We are very pleased to have completed this Phase I/IIA human clinical trial. We strongly believe that such a product could have a significant improvement in the treatment of exocrine pancreatic insufficiency," stated Jean-Nicolas Vernin, Laboratoires Mayoly-Spindler's CEO.
The worldwide market for treatment of exocrine pancreatic insufficiency is estimated to be $1.2 billion. There are over 200,000 patients in the United States who suffer from symptoms of exocrine pancreatic insufficiency.
Under terms of their partnership agreement, Protea receives from Mayoly-Spindler the exclusive marketing rights for the drug in North America.
The two companies plan to commence the phase II human clinical trial in 2012.
Protea Biosciences, Inc. (www.proteabio.com) develops and commercializes new bioanalytical technologies that enable the direct analysis of the proteins, lipids and metabolites produced by living cells and organisms.
Laboratoires Mayoly-Spindler is a privately-owned French pharmaceutical company, founded in 1929, focused primarily on gastroenterology. (www.mayoly-spindler.com).