CATCo Regulatory News (CAT)

23 Jun 2005 07:01

Cambridge Antibody Tech Group PLC23 June 2005 FOR IMMEDIATE RELEASE 07.00 BST, 02.00 EST Thursday 23 June 2005 For further information contact: Weber Shandwick Square Mile (Europe)Cambridge Antibody Technology Tel: +44 (0) 20 7067 0700Tel: +44 (0) 1223 471 471 Kevin SmithPeter Chambre, Chief Executive Officer Yvonne AlexanderJohn Aston, Chief Financial Officer Rachel TaylorRowena Gardner, Director of CorporateCommunications 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 DATA FROM PHASE I CLINICAL TRIAL OF CAT-354 Cambridge, UK - Cambridge Antibody Technology (LSE: CAT; NASDAQ: CATG) todayannounces that preliminary results of a Phase I clinical trial of CAT-354, ahuman anti-IL13 monoclonal antibody being studied as a potential treatment forsevere asthma, showed CAT-354 to be well tolerated with no safety concernsidentified. The objective of the trial, which commenced in September 2004, was to assess thesafety, tolerability and pharmacokinetics of CAT-354. It was a double-blind,placebo-controlled, rising single dose intravenous study in 34 mild asthmaticpatients. Preliminary results showed that CAT-354 was well tolerated at alldoses and there were no identified safety concerns; pharmacokinetics were asanticipated. The trial results will be submitted to an appropriate scientificmeeting in due course. Based on these results, CAT is planning to start a clinical pharmacology studyin the fourth quarter of 2005. This is being planned as a repeat dose allergenchallenge study in patients with asthma. Patrick Round, VP Development at CAT, commented: "CAT-354 is an importantproduct candidate for CAT and this trial was the first clinical step in itsdevelopment as a potential treatment for severe asthma. We are encouraged bythese preliminary results and are now moving forward with plans for a secondclinical trial." - ENDS- Notes To Editors - Cambridge Antibody Technology (CAT): Business: - CAT is a leading biopharmaceutical company, committed to developing fully human monoclonal antibody therapeutics to treat human diseases in areas of unmet medical need - CAT has a strong financial position and expects growing revenues from HUMIRA(R). In addition, CAT has good medium term prospects from 10 further CAT-derived clinical development programmes and significant opportunities for growth in the longer term.Products: - HUMIRA, licensed to Abbott, is the first CAT-derived antibody to be approved for marketing. It was isolated and optimised in collaboration with Abbott and has been approved for marketing as a treatment for rheumatoid arthritis in 58 countries. - There are six further CAT-derived antibodies licensed to partners at various stages of clinical development, including ABT-874 (Abbott), LymphoStat-B, HGS-ETR1, HGS-ETR2 (all HGSI) and MYO-029 (Wyeth). CAT has also licensed its proprietary technologies and patents to several companies, including: Abbott, Amgen, Chugai, Dyax, Genzyme, Human Genome Sciences, Merck & Co, Micromet, Pfizer and Wyeth Research, and three antibody drug candidates are in clinical development at IP licensees. - There is one proprietary CAT human therapeutic antibody product candidate, CAT-354, in clinical development, with one further product candidate, GC-1008 (with Genzyme), in pre-clinical development. Collaborations: - CAT has a broad collaboration with Genzyme for the development and commercialisation of antibodies directed against TGFbeta, a family of proteins associated with fibrosis and scarring, and with potential application in the treatment of some cancers. - CAT has major strategic alliance with AstraZeneca to discover and develop human antibody therapeutics, principally in inflammatory disorders. This provides CAT with the opportunity to build a substantial pipeline of antibody therapeutics with a significant pharmaceutical partner. - CAT has a third co-development collaboration with Amrad.Science: - CAT has an advanced proprietary technology for rapidly isolating human monoclonal antibodies using Phage Display and Ribosome Display systems. CAT has extensive phage antibody libraries, currently incorporating more than 100 billion distinct antibodies, which form the basis for the Company's strategy to develop a portfolio of antibody-based drugs.Business Background: - Based near Cambridge, UK, CAT currently employs around 290 people. - CAT is listed on the London Stock Exchange (CAT) and on NASDAQ (CATG). - CAT raised £41m in its IPO in March 1997 and £93m in a secondary offering in March 2000. - More information can be found at www.cambridgeantibody.com IL-13 and CAT-354: - IL-13 is an interleukin (protein) which has potent immunomodulatory effects. It is primarily secreted by TH2 lymphocytes. It is believed to be a highly relevant target molecule for asthma as a result of its potential role in airways obstruction, acute exacerbations and in chronic airways remodelling. - CAT-354 is the first CAT antibody optimised using CAT's proprietary ribosome display technology to enter clinical development. - CAT-354 is the latest CAT-derived antibody to enter clinical trials. Application of the Safe Harbor of the Private Securities Litigation Reform Actof 1995: This press release contains statements about Cambridge AntibodyTechnology Group plc ("CAT") that are forward looking statements. All statementsother than statements of historical facts included in this press release may beforward looking statements within the meaning of Section 21E of the SecuritiesExchange Act of 1934. These forward looking statements are based on numerousassumptions regarding the company's present and future business strategies and the environment in which the company will operate in the future. Certain factors that could cause the company'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. We caution investors not to place undue reliance on the forward looking statements contained in this press release. These statements speak only as of the date of this press release, and we undertake no obligation to update or revise the statements. This information is provided by RNS The company news service from the London Stock Exchange