June 22, 2010 - Protea Biosciences, Inc., a leading developer of new technology for pharmaceutical research, announced that the company, in partnership with Mayoly-Spindler, a European pharmaceutical company, has commenced a Phase I/IIA human clinical trial for a new recombinant Lipase.The clinical trial will be conducted at the Hospital "la Timone" in Marseilles, France. The goal of the clinical trial is to demonstrate safety and proof-of-concept data for the recombinant lipase as treatment for chronic pancreatitis.
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. This chronic inflammation can lead to chronic abdominal pain and/or impairment of hormone and digestive enzyme functions of the pancreas, and can produce serious weight loss. A lack of digestive enzymes made by the pancreas, results in the inability to properly digest food and absorb nutrients, resulting in malnutrition. Vitamin absorption (A, D, E, and K) is impaired.The main clinical symptoms are fat malabsorption known as steatorrhea, diarrhea, weight loss, abdominal discomfort and abdominal swelling...
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...Laboratoires Mayoly-Spindler is a privately-owned French pharmaceutical company, founded in 1929, essentially focused on gastroenterology... [PDF] Protea Biosciences' Press Release -
