Creative BioMolecules Inc. said Thursday it will receive about $12million from its OP-1 partner to support work leading to the filing ofa premarket approval (PMA) application for the protein.
The $12 million from Stryker Corp., of Kalamazoo, Mich., also willgo toward expanding orthopedic indications for OP-1, whichcurrently is in a pivotal study for non-union fractures, or those thatdon't knit back together. Patient accrual is complete in the study andthe partners are expecting a PMA filing in late 1997.
Through the collaboration Stryker has rights to OP-1 in allorthopedic reconstruction applications. Last fall Stryker expanded thepivotal study to include a supplemental treatment arm in which theprotein is being studied in all long-bone non-union fractures.Additionally, Stryker is studying OP-1 in Europe for acute fractures,foot fractures, fibula defects and an undisclosed target.
Creative BioMolecules, of Hopkinton, Mass., has rights to OP-1 inother indications, and has programs in renal disorders, dentaltherapeutics, central nervous system disorders and osteoporosis.
The protein, in a paste-like formulation, is packed into the defect site,where it induces bone formation. Standard treatment now in non-union fractures is autografting, in which bone is taken from the hipand placed into the defect site to promote growth of new bone cells.
The pivotal study in non-union fractures is comparing use of OP-1 toautografting. Stryker is not disclosing specific details of the study.
Creative BioMolecules' stock (NASDAQ:CMBI) gained 25 centsThursday to close at $9.88. n
-- Jim Shrine
(c) 1997 American Health Consultants. All rights reserved.