MELBOURN, England, May 8 /PRNewswire-FirstCall/ -- Cambridge Antibody Technology (Nasdaq: CATG; London: CAT) today announces the twelve-month follow-up results from a Phase II clinical trial using CAT-152 (lerdelimumab; human anti-TGFBeta2 monoclonal antibody) in patients undergoing surgery for glaucoma and cataract. CAT-152 has been designed to prevent excessive post-operative scarring which is the major reason for long-term failure of glaucoma surgery to lower intraocular pressure.
The trial results will be presented today at the Association for Research in Vision and Ophthalmology (ARVO) 2002 Annual Meeting in Fort Lauderdale by consultant ophthalmic surgeon Mr. David Broadway.
The Phase II clinical trial studied 56 patients who were undergoing combined glaucoma and cataract surgery. Patients were randomized to receive either CAT-152 (36 patients) or matching placebo (20 patients) in a series of four subconjunctival injections that were given on the day of surgery (both immediately pre- and post-operatively), the day after surgery and a week after surgery. The primary objective of the trial was to assess safety and tolerability of CAT-152 injection in this group of patients. A secondary objective was exploration of efficacy of CAT-152 in the glaucoma component of the surgery.
CAT-152 was found to be safe and well tolerated in this trial with no serious drug-related adverse events and no severe injection site reactions reported. There was no evidence of increased inflammation in the anterior chamber of the eye.
Intraocular pressure (IOP) was successfully lowered by glaucoma surgery in both patient groups. Twelve months after operation the achieved IOP was lower in CAT-152 treated patients (mean value 14.4 mmHg) compared to those receiving placebo (mean value 16.9 mmHg) (p=0.03). The proportion of patients achieving IOP below 22mmHg was: CAT-152 100%, placebo 85%; (p = 0.04). Comparing the distribution of patients who achieved IOP in the ranges less than or equal to 14.5mmHg, 15-17.5mmHg, 18-21.5mmHg and greater than or equal to 22mmHg revealed a shift to lower pressures in patients receiving CAT-152 (p=0.05). All these results are statistically significant.
The proportion of patients who required topical medication to manage their IOP was higher in the placebo group: CAT-152, 11% (4/36) compared with placebo 20% (4/20). One of these four placebo patients subsequently underwent repeat glaucoma surgery to control IOP. Intervention after operation with antimetabolite injections (5-fluorouracil) was similar between the two patient groups with 28% (10/36) of CAT-152 treated patients compared to 30% (6/20) placebo patients.
Dr. David Glover, CAT's Medical Director, commented, "The positive outcomes after one year for CAT-152 treated patients are very similar to those observed in our earlier clinical trial of CAT-152 in simple glaucoma filtration surgery. And, in comparison with the previously reported analyses after three and six months of patient follow-up, these results demonstrate that the benefits of CAT-152 treatment have become apparent with longer-term follow-up. Patients treated with CAT-152 achieved lower IOP and fewer needed to return to topical medication. Based upon the earlier encouraging findings, a large multi-center European Phase II/III clinical trial of CAT-152 in glaucoma surgery has commenced, with additional clinical trials expected to be announced later this year."
CAT also announces today that, following receipt of a number of expressions of initial interest from potential partners, it has commenced a process of assessment and investigation of marketing strategies for CAT-152... |
