BETAKINE ENTERS PHASE II TRIALS FOR AMDCeltrix Pharmaceuticals Inc. announced Monday at the Alex.Brown conference that it has begun Phase II clinical trials of itsdrug BetaKine for treating age-related macular degeneration(AMD), the leading cause of blindness in people over the age of55.
The Santa Clara, Calif., company (NASDAQ:CTRX) is targetingpatients with exudative (or wet) AMD, who comprise about 10percent of the total 600,000 AMD-affected individuals in theU.S. annually. The condition is characterized by a slowdeterioration of the area of the retina that is responsible forfine, central vision. Those affected with wet AMD usually golegally blind in 12 to 18 months.
The investigator-sponsored Phase I/II feasibility study onBetaKine (transforming growth factor-beta-2) for treating AMDwas conducted by Bert Glaser, director of The Retina Instituteof Maryland. Of the 19 AMD patients enrolled in this study,Glaser has followed 10 for six months after treatment. Seven ofthose patients have achieved stable vision, and one hasimproved.
Celtrix is also investigating BetaKine's ability to heal macularholes, a separate condition of the eye (but also age-related) inwhich "pieces of the retina get pulled loose" as the vitreoushumor (the transparent jelly that fills the eyeball) contractsand dries up. In contrast, in AMD the macular layer becomesprogressively thinner, explained Dale Stringfellow, president ofCeltrix. His company reported preliminary data from Phase IItrials on BetaKine for this indication last week at theAssociation for Research in Vision and Ophthalmology meetingin Sarasota, Fla.
(c) 1997 American Health Consultants. All rights reserved.