Celtrix Pharmaceuticals Inc. decided Monday to discontinuedevelopment of BetaKine for ophthalmic indications following thedrug's failure in a Phase II trial for age-related macular degeneration,the second setback for BetaKine in the treatment of eye disorders.
The first disappointment occurred last October when Phase III trialsfor repairing macular holes in the retina failed to show efficacy. TheSanta Clara, Calif.-based company's stock (NASDAQ:CTRX)plummeted 63 percent on the news Oct. 31 to $2.44 per share.
Celtrix Monday lost $1.19, closing at $1.75 per share, a 40 percentdrop.
Ray Cummings, vice president of business development, said endingthe BetaKine ophthalmic program will not have any immediate effecton the staff. The company trimmed its work force by one-third Nov.17 following the interim analysis of data from the macular holestudies.
The November restructuring was designed to cut Celtrix's burn rateto $13.5 million a year. Cummings said the company has achievedthat goal. As of Dec. 31, Celtrix had $23.6 million in cash.
BetaKine is a recombinant form of transforming growth factor beta-2, a protein involved in the growth and behavior of cells on alocalized basis.
Celtrix licensed BetaKine to Genzyme Corp., and is collaboratingwith the Cambridge, Mass.-based company on development of thedrug for non-ophthalmic indications, such as wound healing andmultiple sclerosis.
A Genzyme spokeswoman said the BetaKine ophthalmic studies willnot affect its on-going trials. Genzyme has BetaKine in Phase II trialsfor leg ulcers and Phase I studies for multiple sclerosis.
Cummings said Celtrix will focus its internal resources onSomatoKine, an insulin-like growth factor-1 coupled with a bindingprotein that is involved in muscle and bone formation.
Celtrix is developing SomatoKine for treatment of muscle wastingand has a collaboration with the Japanese pharmaceutical company,Green Cross Corp., for development of the drug for osteoporosis inJapan.
Celtrix is discussing partnerships with other corporations to continueSomatoKine's development for muscle wasting and for osteoporosisoutside Japan, according to Cummings.
The decision to end the BetaKine ophthalmic program was madeafter an interim analysis of Phase II data showed "no clinicalbenefit."
BetaKine was administered to the macular region of the eye inpatients undergoing standard vitrectomy. The aim of the 90-patientstudy was to slow or halt the progression of age-related maculardegeneration by using BetaKine to inhibit the formation of abnormalblood vessels growing under the retina. The disease affects about600,000 people in the U.S. each year and leads to blindness.
In the macular hole study, BetaKine was being used to improvetissue repair in connection with vitrectomy. n
-- Charles Craig
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