Kuros receives orphan drug designation for a novel fusion protein for the treatment of solitary bone cysts
Kuros Biosurgery AG announced that the food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to the novel bioactive substance of Kuros' bone-repair product, I-040302, for the treatment of solitary bone cysts. This is a further achievement in the development of the product after receiving ODD in Europe in 2006. It is anticipated that a clinical study involving I-040302 will be initiated this year.
Solitary (or unicameral) bone cysts are rare lesions that occur mostly in children between the ages of nine and 14 years of age and present as fractures in 75 percent of cases. The most common complication of bone cysts is persistence or re-fracture, and disturbances of the growth plate. This may result in growth arrest and limb shortening. More rarely, severe and debilitating conditions such as septic or degenerative arthritis and avascular necrosis have been reported.
The ODD is granted to development-stage, novel therapeutics that offer potential value in the treatment of rare diseases. In the United States, ODD provides a variety of incentives, including seven years of market exclusivity, should the product receive FDA approval for this indication.
The bone-repair product, I-040302, is licensed to Baxter International Inc. under a 2005 collaboration and license agreement. The product consists of a fusion protein derivative of human parathyroid hormone (PTH) combined with Baxter's TISSEEL Fibrin Sealant.
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