Cambridge Antibody Technology Announces Preliminary Results of Second Pivotal Trabio(R) Clinical Trial
Tuesday March 22, 9:33 am ET
CAMBRIDGE, England, March 22 /PRNewswire-FirstCall/ -- Cambridge Antibody Technology (LSE: CAT - News; Nasdaq: CATG - News) today announces that in its second pivotal ('International' Phase III) clinical trial, Trabio® 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."
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 TGFB, 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 pounds Sterling in its IPO in March 1997 and 93m pounds 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 (TGFB2) -- 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, TGFB2 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. |
