BioWorld International Correspondent
LONDON - Cambridge Antibody Technology Group plc announced positive 12-month follow-up results in a UK Phase II trial of CAT-152 to prevent eye scarring in patients who had surgery for glaucoma and cataract.
CAT, based in Melbourn, developed the product on its own, but last week CAT said there have been expressions of interest from potential partners and it is now considering the marketing strategy for CAT-152 (lerdelimumab), an anti-TGF beta 2 human monoclonal antibody. Overactivity of TGF beta 2 causes scarring, which is the main reason glaucoma surgery can fail.
David Glover, CAT's medical director, noted that potential partners have been watching CAT-152's progress. "We previously said our priority was to do the trial. Now that we've got the data, we can spend some time thinking [about] who is the correct partner, and the correct strategy for commercializing [CAT] 152," he told a teleconference audience.
The results were presented at the Association for Research in Vision and Ophthalmology 2002 annual meeting in Fort Lauderdale, Fla., last week.
The trial involved 56 patients undergoing combined glaucoma and cataract surgery who were randomized to receive CAT-152 (36 patients) or placebo (20 patients). Intraocular pressure (IOP) was successfully lowered by the glaucoma surgery in both patient groups, but 12 months after treatment the IOP was lower in CAT-152-treated patients (mean value 14.4 mmHg) than in placebo patients (mean value 16.9 mmHg).
"There was a statistically significant difference in favor of CAT-152 for IOP," Glover said. "More patients are at a favorable pressure level, fewer needed topical medication [to reduce IOP], and most important of all, safety was confirmed." Despite patients on placebo being more likely to use topical medication, the mean pressure was higher in the placebo group.
The results after one year for CAT-152-treated patients were similar to those in an earlier trial of CAT-152 in glaucoma surgery alone. Glover also noted that the results demonstrated that the benefits of CAT-152 treatment have become apparent with longer-term follow up. "The best time to judge if CAT-152 works effectively is at one year."
Based on the earlier findings, a large multicenter European Phase II/III trial in glaucoma surgery already has begun. Glover said CAT is in discussions with the FDA to set up a U.S. trial. "The FDA is interested in the endpoint and would like to see results consistent over a period of time," Glover said.