Trabio(R) Trial Results
Cambridge Antibody Tech Group PLC
22 March 2005
FOR EMBARGO
14.30 GMT, 09.30 EST Tuesday 22 March 2005
For further information contact:
Cambridge Antibody Technology Weber Shandwick Square Mile(Europe)
Tel: +44 (0) 1223 471 471 Tel: +44 (0) 20 7067 0700
Peter Chambre , Chief Executive Officer Kevin Smith
John Aston, Chief Financial Officer Yvonne Alexander
Rowena Gardner, Director 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 PRELIMINARY RESULTS OF SECOND PIVOTAL
TRABIO(R) CLINICAL TRIAL
Cambridge, UK Cambridge Antibody Technology (LSE: CAT; NASDAQ: CATG) today
announces that in its second pivotal ('International' Phase III) clinical
trial, Trabio(R) failed to meet the primary endpoint of improving the outcome of
surgery for glaucoma. This result is consistent with the result of the first
pivotal ('European' Phase II/III) clinical trial, which was announced in
November 2004.
CAT is now terminating further development of Trabio as a potential treatment
for improving the outcome of glaucoma surgery, as indicated in November 2004.
Also in November 2004, CAT announced that it would be minimising, from that
time, all future costs in connection with Trabio development.
Peter Chambre, Chief Executive Officer of CAT, comments "Given the results
announced in November from the first Trabio trial, this is an outcome for which
we have planned. We took the decision at that time to minimise all costs
associated with this programme. We will focus our resources on product
opportunities such as the AstraZeneca alliance, GC-1008 with Genzyme, and
CAT-354, our proprietary asthma candidate."
- ENDS -
Notes to Editors
Cambridge Antibody Technology (CAT):
• CAT is a biopharmaceutical company using its proprietary technologies and
capabilities in human monoclonal antibodies for drug discovery and drug
development. Based near Cambridge, England, CAT currently employs around 280
people.
• CAT is a leader in the discovery and development of human therapeutic antibodies
and 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. These libraries form the basis for the Company's strategy to develop
a portfolio of antibody-based drugs.
• Three CAT human therapeutic antibody product candidates are at various stages
of clinical development, with one further product candidate in pre-clinical
development.
• HUMIRA, the leading CAT-derived antibody, isolated and optimised in collaboration
with Abbott, has been approved for marketing as a treatment for rheumatoid
arthritis in 51 countries.
• Six further licensed CAT-derived human therapeutic antibodies are in clinical
development by licensees, with four further licensed product candidates in
pre-clinical development.
• CAT has alliances with a number of pharmaceutical and biotechnology companies
to discover, develop and commercialise human monoclonal antibody-based products.
• On 22 November 2004, CAT announced a major strategic alliance with AstraZeneca
to discover and develop human antibody therapeutics in inflammatory disorders.
• 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.
• CAT has also licensed its proprietary technologies to several companies. CAT's
licensees include: Abbott, Amgen, Chugai, Genzyme, Human Genome Sciences, Merck
& Co, Pfizer and Wyeth Research.
• CAT is listed on the London Stock Exchange and on NASDAQ. CAT raised £41m in
its IPO in March 1997 and £93m in a secondary offering in March 2000.
Trabio (lerdelimumab, CAT-152)
• Trabio is a fully human monoclonal antibody that neutralises Transforming Growth
Factor Beta 2 (TGFBeta2) - a protein produced in response to injury in the eye
and believed to be responsible for the formulation of excessive scar tissue,
which is the main reason for failure of glaucoma surgery.
• Trabio has been developed by CAT as a potential treatment for improving outcomes
in glaucoma filtration surgery (trabeculectomy). Results from early clinical
trials indicated lower pressure in the eye and a trend for reduced post-operative
intervention in patients who received Trabio, which it was hoped would translate
into reduced failure of surgery. Such evidence of clinical efficacy justified
progressing the antibody into three later stage trials.
Glaucoma
• Glaucoma is a sight-threatening eye condition where the optic nerve becomes
damaged, usually due to an increased pressure of fluid within the eye.
• Treatment usually involves the use of topical eye drops to lower pressure;
however, drug treatment may not prove effective or may not be tolerated by some
patients. Accordingly, surgical or laser procedures can be used to lower the
pressure by improving drainage. However, in response to the surgical injury,
TGFBeta2 is produced at the wound injury site resulting in the formation of scar
tissue.
• Excessive production of scar tissue at the wound site is the main reason for
failure of the surgical procedure Pivotal Clinical trials
• The first pivotal 'European' clinical trial, comparing Trabio with placebo,
began in February 2002 and was carried out in 344 patients
in six European countries. Preliminary results were announced on 9 November 2004.
• The second pivotal 'International' clinical trial, comparing Trabio with
placebo, started in October 2002 and was carried out in 393 patients in six
European countries and South Africa.
• The primary endpoint is the proportion of patients achieving treatment success
defined as an Intra Ocular Pressure (IOP) in the range 6-16 mm Hg and no other
anti-glaucoma medication, at months 6 and 12.
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 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.
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