Glycomed Inc. has successfully completed Phase I clinical trialsin normal volunteers for Galardin MPI, its first productintended to treat corneal ulcers, the Alameda, Calif., companysaid.
The Phase I studies showed that Galardin MPI attacked theulcers by suppressing the action of enzymes that attackcarbohydrate-protein complexes and other components of thecornea's support structure. In the studies Galardin was safe andtolerable at 50, 200, 400 and 800 micrograms per milliliter, thecompany said.
Galardin MPI has been designated an orphan drug by the FDA.
Glycomed said it expects to begin Phase II/III testing inNovember, a month ahead of schedule. Corneal ulcers affect160,000 people each year in the U.S., and there is no singletreatment available.
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