CAT-152 results

Cambridge Antibody Tech Group PLC 14 November 2001 01/CAT/21 FOR IMMEDIATE RELEASE 07.00 GMT, 02.00 EST Wednesday 14 November 2001 For Further Information Contact: Cambridge Antibody Technology Weber Shandwick Square Mile (Europe) Tel: +44 (0) 1763 263 233 Tel: +44 (0) 20 7601 1000 David Glover, Medical Director Kevin Smith John Aston, Finance Director Graham Herring Rowena Gardner, Head of Corporate Communications BMC Communications/The Trout Group (USA) Tel: 001 212 477 9007 Brad Miles, ext 17 (media) Brandon Lewis, ext.15 (investors) CAMBRIDGE ANTIBODY TECHNOLOGY ANNOUNCES SIX MONTH FOLLOW-UP RESULTS FOR CAT-152 Follow-up results presented at major ophthalmology congress Melbourn, UK... Cambridge Antibody Technology (LSE: CAT; NASDAQ: CATG) today announces the six month follow-up results from a Phase II clinical trial using CAT-152 (lerdelimumab; human anti-TGFb 2 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 why glaucoma surgery can fail to lower intraocular pressure in the long term. The trial results will be presented today at the American Academy of Ophthalmology in New Orleans by consultant ophthalmic surgeon Dr David Broadway. The Phase II clinical trial studied 56 patients who were undergoing combined glaucoma and cataract surgery. Patients were randomised to receive either CAT-152 (36 patients) or matching placebo (20 patients) in a series of four subconjunctival injections which 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. As previously reported in August (three month data), 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 surgery in both patient groups. Six months after operation the achieved IOP was lower in patients receiving CAT-152 (mean value 14.5 mmHg) compared to those receiving placebo (mean value 16.7 mmHg). The proportion of patients achieving IOP below 22mmHg was: CAT-152 100%, placebo 80%; (p = 0.013). At lower IOP thresholds a similar trend was seen (less than 18 mmHg: CAT-152 83%, placebo 65%; less than 15mmHg: CAT-152 50%, placebo 30%). In the early post-operative period intervention with 5FU injection was used in 10 of 36 (28%) CAT-152 treated patients compared to 2 of 20 (10%) on placebo. By six months after surgery resumption of long term topical IOP lowering medication was needed in 3 of 36 (8%) CAT-152 treated patients compared to 3 of 20 (15%) on placebo. One of these three placebo patients subsequently underwent repeat trabeculectomy to control IOP. Commenting on the results, Dr David Glover, CAT's Medical Director said, 'Six months after operation we can see a clearer trend towards a better long-term outcome in those patients treated with CAT-152 than was apparent in the three month follow-up results, highlighting the importance of long-term follow-up after surgery for glaucoma.We were particularly pleased that these trial results are being presented at the highly prestigious American Academy of Ophthalmology today' -ENDS- Notes to Editors: Glaucoma and Glaucoma Surgery Glaucoma is the name for a group of eye conditions in which the optic nerve is damaged at the point where it leaves the eye. The main cause of this damage is raised pressure inside the eye (intraocular pressure, IOP). Glaucoma affects 2% of people aged over 40 years, and the percentage of people affected rises with age such that 5% of over 65's are affected, rising to around 8% of over 75's. Glaucoma is a major source of blindness. Treatment is generally aimed at lowering the pressure in the eye to prevent long term damage to eyesight. Eye drops are the mainstay of treatment but more than 10% of patients require surgery to control pressure. Trabeculectomy is the most commonly performed surgical operation for glaucoma. Surgery lowers IOP by improving the drainage of fluid in the eye. Scarring is the main cause of failure of surgery for glaucoma. There are no approved treatments to prevent this scarring. CAT has estimated that up to 250,000 patients undergoing operations in the US and Western Europe each year could benefit from treatment with CAT-152. Quite commonly surgeons will combine surgery for glaucoma with a cataract extraction and intraocular lens implantation. Both glaucoma and cataract are conditions that increase in prevalence with increasing age hence they may co-exist in elderly patients. Patients are generally classified as failures of surgery if there is a need to resume topical medication and/or further surgery is required. Attainment of IOP levels such as 22mmHg or18mmHg are widely used. CAT-152 CAT-152 is a fully human anti-TGFb 2 monoclonal antibody developed by CAT to specifically neutralise the cytokine TGFb 2, overactivity of which is believed to cause scarring in and around the eye. CAT-152 is being developed as a treatment to prevent scarring in the eye following glaucoma surgery. Two year follow up results from a phase I/IIa clinical trial in 24 patients undergoing simple glaucoma surgery released in April 2001 showed that the group of patients treated with CAT-152 at the time of surgery achieved significantly lower intraocular pressure (IOP) than those treated with placebo. Mean values two years after surgery were 13.6mmHg (CAT-152) compared to 17.7mmHg (placebo) (p= 0.004). The pressure difference was apparent despite clear trends for less use of post operative injections and less use of topical medication in the CAT-152 group. The results were presented at the Association for Research in Vision in Ophthalmology (ARVO) 2001 conference in Fort Lauderdale, Florida, USA. Three month follow-up results of a Phase II clinical trial using CAT-152 in combined cataract and glaucoma surgery were announced 22 August 2001 (see news release 01/CAT/15). Efficacy Efficacy is measured in terms of reduced need for intervention post surgery, or in terms of lower IOP. Cambridge Antibody Technology (CAT) CAT is a UK biotechnology company using its proprietary technologies in human monoclonal antibodies for drug discovery and drug development. Based near Cambridge, England, CAT currently employs around 250 people. CAT is listed on the London Stock Exchange and on NASDAQ since June 2001. CAT raised £41m in its IPO in March 1997 and £93m in a secondary offering in March 2000. CAT has an advanced platform technology for rapidly isolating human monoclonal antibodies using phage display systems. CAT has extensive phage antibody libraries, currently incorporating more than 100 billion distinct antibodies. These libraries form the basis for the Company's strategy to develop a portfolio of antibody-based drugs and to utilise antibodies as tools for target validation. Six human therapeutic antibodies developed by CAT are at various stages of clinical trials. CAT has alliances with a large number of biotechnology and pharmaceutical companies to discover develop and commercialise human monoclonal antibody-based products. CAT has also licensed its proprietary human phage antibody libraries to several companies for target validation and drug discovery. CAT's partners include: Eli Lilly, Pfizer, Abbott , Genetics Institute, Wyeth-Ayerst, Human Genome Sciences, Pharmacia, Oxford GlycoSciences, Genzyme, Immunex, Zyomyx, Elan, Merck & Co and Xerion. Application of the Safe Harbor of the Private Securities Litigation Reform Act of 1995: This press release contains statements about Cambridge Antibody Technology Group plc ('CAT') that are forward looking statements. All statements other than statements of historical facts included in this press release may be forward looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934. These forward looking statements are based on numerous assumptions regarding CAT's present and future business strategies and the environment in which CAT will operate in the future. Certain factors that could cause CAT's actual results, performance or achievements to differ materially from those in the forward looking statements include: market conditions, CAT's ability to enter into and maintain collaborative arrangements, success of product candidates in clinical trials, regulatory developments and competition.
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