Trabio(R) Trial Results
10 November 2004 - 1:37AM
UK Regulatory
RNS Number:0316F
Cambridge Antibody Tech Group PLC
09 November 2004
04/CAT/12
FOR IMMEDIATE RELEASE
14.30 GMT, 9.30 EST Tuesday 9 November 2004
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 Sarah MacLeod
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 TRABIO(R) PHASE
II/III CLINICAL TRIAL
Cambridge, UK Cambridge Antibody Technology (LSE: CAT; NASDAQ: CATG) today
announces preliminary results from its first pivotal ('European' Phase II/III)
clinical trial of Trabio(R). The trial, which started in February 2002, was
carried out in 344 patients in six European countries. On the basis of a
preliminary analysis, Trabio has failed to meet the primary endpoint of
improving the outcome of surgery for glaucoma compared to placebo. The
preliminary analysis by itself does not support the filing of a Biologics
Licence Application (BLA) in 2005. Data from a second pivotal ('International'
Phase III) clinical trial of Trabio are expected in early 2005.
CAT will provide further information with its Preliminary Results announcement
on 22 November 2004.
- 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 270
people.
CAT is a leader in the discovery and development of human therapeutic antibodies
and has an advanced proprietary platform 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.
Four CAT human therapeutic antibody products are now at various stages of
clinical development, with one further product candidate in pre-clinical
development.
HUMIRA(TM), 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. In
particular, 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. This collaboration has so far given rise
to one antibody product candidate at clinical development stage, and one at
pre-clinical development stage.
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
Primary endpoint
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.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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