Celtrix Pharmaceuticals Inc. announced Monday that it hasbegun a pivotal Phase III clinical trial using BetaKine to treatmacular holes, a potentially blinding ophthalmic disorder.
Celtrix of Santa Clara, Calif., reported the results of Phase IIstudies on BetaKine -- recombinant transforming growth factorbeta-2 -- in mid-November at the annual meeting of theAmerican Academy of Ophthalmology in Chicago. Those datademonstrated that BetaKine is most effective in restoring visionto people with macular holes in the retina if those individualsare treated early. The study included 93 patients.
The company also reported at the meeting one year follow-updata on a second Phase II trial of 90 patients. In this trial, 97percent of the patients receiving high-dose BetaKine (1,300nanograms) during the standard surgical procedure, termedvitrectomy, had a flattening of the macular hole, comparedwith 47 percent in the placebo group.
Moreover, 79 percent of patients in the high-dose groupshowed two-line improvement, as measured on a standard eyechart, and 72 percent showed a three-line improvement. Only30 percent of those in the placebo group showed three-lineimprovement.
"The tissue repair and vision improvement was more thandouble the outcome seen with patients receiving vitrectomywith the placebo," commented Dale Stringfellow, president andchief executive officer of Celtrix (NASDAQ:CTRX). He added thatthe Phase III studies will employ "virtually the same placebo-controlled treatment protocol and an equivalent dose ofBetaKine."
Approximately 120 patients with macular holes will beenrolled in the Phase III trials, which are being conducted atThe Retina Institute of Maryland, The Bascom Palmer EyeInstitute at the University of Miami School of Medicine andAssociated Retinal Consultants, located near Detroit.
-- Jennifer Van Brunt Senior Editor
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