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CAMBRIDGE
ANTIBODY TECHNOLOGY (CAT) ANNOUNCES CLINICAL TRIALS UPDATE
Cambridge, UK …
Cambridge Antibody Technology Group plc (LSE: CAT; NASDAQ: CATG) today announces
the completion of enrolment in the Phase III pivotal International clinical
trial of TrabioTM, a human anti-TGFb monoclonal antibody, in patients undergoing
first time surgery for glaucoma (trabeculectomy). A total of 393 patients in six
European countries and South Africa were randomised in the double-blind trial
which compares Trabio with placebo. Data from this trial are expected in early
2005 when all patients will have completed at least one year of follow-up post
surgery.
CAT also reports the announcement by its licensee Human Genome Sciences, Inc
(NASDAQ: HGSI) that it has begun dosing patients in a Phase II clinical trial of
LymphoStat-BTM, a human monoclonal antibody which modulates the activities of
B-lymphocytes, for the treatment of rheumatoid arthritis. The double-blind,
placebo-controlled multi-centre Phase II trial will evaluate safety, optimal
dosing and efficacy of LymphoStat-B in approximately 230 patients with active
rheumatoid arthritis who have failed prior therapy.
LymphoStat-B was isolated at CAT in collaboration with HGSI and licensed to HGSI
in 2001.
-ENDS -
Notes to Editors
Cambridge Antibody Technology (CAT):
- CAT is a UK-based
biotechnology 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 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.
- Three CAT human therapeutic
antibody products are now in clinical development, with two further product
candidates in pre-clinical development.
- HUMIRA (TM), the leading
CAT-derived antibody, isolated and optimised in collaboration with Abbott
has been approved by the US Food and Drug Administration for marketing in
the US and by the European Commission for marketing in the EU as a treatment
for rheumatoid arthritis.
- Five further licensed
CAT-derived human therapeutic antibodies in clinical development, with three
further licensed product candidates in pre-clinical development.
- CAT has a major co-development
collaboration with Genzyme and alliances with a number of pharmaceutical and
biotechnology companies to discover, develop and commercialise human
monoclonal antibody-based products.
- CAT has also licensed its
proprietary technologies to several companies. CAT’s licensees include:
Abbott, Amgen, Chugai, Human Genome Sciences, Merck & Co, Pfizer and
Wyeth Research.
- 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.
TrabioTM (lerdelimumab)
- Trabio is a human anti-TGFb
monoclonal antibody with anti-scarring effects being developed for improving
outcomes in glaucoma filtration surgery (trabeculectomy). There are three
ongoing clinical trials of Trabio.
- Enrolment is complete in the
European Phase II/III clinical trial of Trabio, with 344 patients enrolled
in six countries. Data from this trial are expected to be available towards
the end of 2004 when all patients will have completed at least one year of
follow-up post surgery.
- A head-to-head comparison of
Trabio with 5-Flurouracil (5-FU) in patients undergoing trabeculectory is
underway in the US. Patient recruitment is ongoing.
- Enrolment in the International
Phase III clinical trial was commenced in October 2002. Patients have been
enrolled in seven countries: Hungary, Ireland, Italy, Netherlands, Poland,
South Africa, Spain.
- Trabio is a trademark of
Cambridge Antibody Technology Limited
LymphoStat-BTM (belimumab)
- LymphoStat-B is a human
monoclonal antibody that specifically recognises and inhibits the biological
activity of B-lymphocyte stimulator (BlyS). BLyS is a naturally
occurring protein, discovered by HGSI, that is required for the development
of B-lymphocyte cells into mature plasma B cells. Plasma B cells produce
antibodies.
- Laboratory studies have
indicated that higher than normal levels of BLyS may contribute to the
pathogenesis of autoimmune diseases, such as rheumatoid arthritis and
systemic lupus erythematosus. Autoimmune diseases are diseases in which the
body is attacked by its own immune system.
- LymphoStat-B is also in Phase
II clinical trials for systemic lupus erythematosus.
- LymphoStat-B is a trademark of
Human Genome Sciences, Inc
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.
For further information contact:
Cambridge Antibody Technology
Tel: +44 (0) 1223 471 471
Peter Chambré, Chief Executive Officer
John Aston, Chief Financial Officer
Rowena Gardner, Director of Corporate Communications
Weber Shandwick Square Mile (Europe)
Tel: +44 (0) 20 7067 0700
Kevin Smith
Rachel Lankester
BMC Communications/The Trout Group (USA)
Tel: +1 212 477 9007
Brad Miles, ext 17 (media)
Brandon Lewis, ext 15 (investors)
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