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CHIRON SUSPENDS EPIDERMAL GROWTH FACTOR PHASE III TRIALS

Executive Summary

CHIRON SUSPENDS EPIDERMAL GROWTH FACTOR PHASE III TRIALS in corneal defects due to a "significant number" of premature patient withdrawals, the Emeryville, Calif.-based biotech firm announced Jan. 19. "A significant number of patients in these trials reported pain in the eye following administration of the current ophthalmic formulation of EGF (epidermal growth factor)," Chiron said. Because of the premature patient withdrawals, Chiron added, the study results "have precluded a meaningful evaluation . . . of the effectiveness of EGF for the treatment of corneal defects." The double-blind placebo trial involved about 34 patients, Chiron said. The suspension of Phase III trials will not allow Chiron to meet its early 1988 target date for an NDA filing, the company noted. Chiron said it could not project a new filing date "until the issues presented by these trials are addressed." Chiron said it is "looking at both the concentration of EGF and the components of the delivery formulation." Recombinant EGF is Chiron's lead therapeutic product in development. The biotech firm has an R&D agreement with J&J's Ethicon subsidiary covering development and marketing of a line of wound healing products stemming from Chiron's growth factor research, including EGF. However, the corneal defect indication is not one of the uses covered in the Ethicon agreement, which is primarily focused on uses synergistic with the J&J subsidiary's sutures business. "While these findings are disappointing in the light of the promising results observed in the initial clinical trials with EGF for corneal defects, we continue to believe that EGF has an important role to play as a useful wound healing agent for ophthalmic use," Chiron Ophthalmics President William Link commented. "Clinical trials for other ophthalmic indications are ongoing and further investigations will now be initiated with other formulations of EGF, in an attempt to overcome these problems related to its use in corneal defects." In addition to treatment of non-healing corneal defects, Chiron is also studying EGF in corneal transplants and ophthalmic burns.
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