Celtrix Pharmaceuticals Inc. on Tuesday started clinical trials ofBetaKine, its recombinant transforming growth factor beta-2, for athird ophthalmic disorder.A 20-patient Phase I/II feasibility study has begun using BetaKine totreat retinal edema, a disorder associated with post-surgical eyeinflammation, diabetic retinopathy and other inflammatory conditions.The treatment will be applied topically to the macula. The trial, to beconducted at The Retina Institute of Maryland, will compare safety andpotential for improving visual acuity to a placebo control."With 20 patients and a control design, we can get early stageefficacy," Sandra McNamara, Celtrix's vice president and chieffinancial officer, told BioWorld. "This is more than a safety study. It'sdesigned to test the product's utility in this application."Celtrix, of Santa Clara, Calif., licensed system and tissue-repair rightsfor BetaKine to Genzyme Corp., of Cambridge, Mass. Celtrix said it isin the final stages of completing a pivotal Phase III study for treatingmacular holes, and is under way with a Phase II study for treating age-related macular degeneration.In areas where Genzyme has rights, BetaKine has completed a PhaseI/II study for dermal wound repair and is in a Phase I study for multiplesclerosis.Celtrix said leveraging its technology over different ophthalmicapplications should reduce development costs and speed thecommercialization process. About 400,000 people per year worldwidesuffer from the three retinal conditions which are under clinicalinvestigation with BetaKine, the company said. _ Jim Shrine
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