FDA's Office of Orphan Products Development has awarded CeltrixPharmaceuticals Inc. $600,000 to support Phase III trials of BetaKinefor treatment of macular holes.
The two-year research grant will be paid in increments of $300,000each year.
FDA granted the growth factor-beta-2 product orphan status inJanuary. There are approximately 10,000 cases of macular holes(non-traumatic wounds of the eye) each year in the U.S. The woundsoccur in the central region of the retina, causing loss of fine visionand often leading to blindness in the affected eye.
Celtrix (NASDAQ:CTRX) reported preliminary Phase II trial results onBetaKine in May at the annual meeting of the Association forResearch in Vision and Ophthalmology. The 90-patient studycompared two doses of BetaKine and placebo. It found that afterthree months of healing, the macular hole had closed in 96 percent ofthe eyes receiving the higher dose of BetaKine and 93 percent ofeyes receiving the lower dose, while macular holes closed in only 55percent of patients receiving placebo.
In addition, substantial vision was restored in 76 percent of patientsreceiving the higher dose of BetaKine. Celtrix said it plans to beginPhase III testing by the end of this year.
According to Celtrix, vitrectomy (extraction of the vitreous chamberof the eye) is the standard surgical procedure for treating macularholes; it results in some retinal repair in 40 to 60 percent of eyes.BetaKine is applied directly to the damaged retina during vitrectomy.
The drug is also in clinicals for the treatment of age-related maculardegeneration and venous stasis ulcers. In addition, Celtrix of SantaClara, Calif., is pursing development of BetaKine for treatment ofcorneal wound healing, retinal (macular) edema and systemic,degenerative diseases such as multiple sclerosis, muscle wasting andosteoporosis.
FDA's Office of Orphan Products Development issues grants solely tosupport clinical trials of orphan products; that is, products fordiseases and conditions affecting fewer than 200,000 people in theU.S. These products include drugs, biologics, medical devices andfoods for medical purposes.
A total of 20 grants were awarded for fiscal year 1993, primarily touniversities and research institutes. Kabi Pharmacia Inc. andTherapeutic Antibodies Inc. were the only other companies toreceive awards. Kabi is studying IGF-I for treatment of Gh receptordeficient children, and Therapeutic Antibodies is conducting a clinicaltrial of polyspecific crotalid antivenin.
FDA issues a request for grant applications once a year. A request forfiscal 1994 grants was announced in the Sept. 28 Federal Register.The agency intends to award approximately $1.5 million for no morethan four grants of up to $200,000 each in direct costs per year, plusapplicable indirect costs for up to two years.
-- Brenda Sandburg News Editor
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