Phase I/II Results With HBI's 4197X-RA
After completing interim analysis of a Phase I/II clinical trial, Houston Biotechnology Inc has reported a trend towards less lens capsule opacification in patients treated with its 4197X-RA Immunotoxin to prevent the formation of secondary cataract.
Donald Clark, vice president for development and medical affairs, said that the 50-unit dose (the level predicted to have clinical efficacy), was well-tolerated, with a safety profile similar to placebo, while a high-dose group (175 units) had more ocular inflammation than with the placebo or 50-unit dose. Inflammation resolved in four-to-seven weeks with standard anti-inflammatory treatment. The trial will have a two-year follow-up period.
Results of a Phase II trial in patients undergoing bilateral cataract surgery should help the company choose a suitable dose and endpoints to proceed with pivotal trials.
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