Protea Announces Completion of Human Clinical Trial for New Biopharmaceutical
Protea Biosciences, a leading developer of new technology for pharmaceutical research, recently announced 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
“The study results are fully in accordance with our expectations,” said 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 reatment of exocrine pancreatic insufficiency,” added 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
Protea Biosciences, Inc. 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.
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