Celtrix Pharmaceuticals Inc. announced Tuesday that FDA hasgranted orphan drug status to its transforming growth factor-beta-2, tradenamed BetaKine, for treating macular holes.Orphan drug designation confers seven-year exclusivemarketing rights to companies that are first to the market withdrugs that address disease populations of 200,000 or less.
Bruce Pharriss, chief executive officer of the Santa Clara, Calif.,company (NASDAQ:CTRX), told BioWorld that Celtrix will beginPhase III trials of BetaKine with 60 to 90 patients for themacular hole indication in the second quarter of 1993. "Thetrial should take six to 12 months to complete," he said. "Weplan to file a product license application before the end ofcalendar year 1994."
Macular holes are non-traumatic wounds of the eye that occurin the retina and can damage vision, sometimes leading to legalblindness. Approximately 10,000 cases of macular holes arerecorded each year in the U.S. The malady is treated with asurgical procedure known as a vitrectomy, which can stopprogression of retinal damage in 40 percent to 60 percent ofcases.
But according to Pharriss, when a vitrectomy is accompaniedby application of BetaKine to the macular hole, the success raterises. "This product doubles the effect of surgery," he said. "Inour Phase II studies, we're seeing responses in 85-90 percentof patients when we use BetaKine in conjunction with surgery."
Celtrix's stock closed Tuesday at $10, up 25 cents a share.
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