Glycomed Inc. announced Thursday that it has started PhaseII/III clinical trials on its carbohydrate-based drug GalardinMPI for treating corneal ulcers. The FDA granted Galardinorphan drug status last January.
Corneal ulcers affect about 160,000 Americans annually andcan cause blindness in people who don't respond to currenttherapies. Galardin is a matrix metalloproteinase inhibitor,which promotes healing by blocking the activity of a "majorclass of enzymes active in destroying tissues," Brian Atwood,Glycomed's senior vice president of operations, told BioWorld."Bacteria make metalloproteinases, metastasizing tumor cellsproduce them, and neutrophils produce them," he said.
Atwood claims that Galardin is the only product available fortreating corneal ulcers, although "a few other products(including epidermal growth factor and fibronectin, weretouted in the past), but very few or none are actually in clinicaldevelopment."
The Phase II/III trials will enroll a total of 800 patients withmild, moderate and severe ulcers, including patients withinfected ulcers or sterile ulcers associated with rheumatoidarthritis.
"The company intends to finish Phase II/III clinical testing ofGalardin MPI as treatment for all corneal ulcers by the end of1993 and to complete the data analysis for an NDA submissionin mid-1994," said Alan Timms, the Alameda, Calif., company'spresident and chief executive officer. -- Jennifer Van Brunt
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