Cambridge Antibody Tech Group PLC
8 May 2002
FOR IMMEDIATE RELEASE
07.00 BST, 02.00 EST Wednesday 8 May 2002
For Further Information Contact:
Cambridge Antibody Technology Weber Shandwick Square Mile (Europe)
Tel: +44 (0) 1763 263 233 Tel: +44 (0) 20 7950 2800
David Glover, Medical Director Kevin Smith
John Aston, Finance Director Graham Herring
Rowena Gardner, Head of Corporate
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
POSITIVE POSITIVE12 MONTH PHASE II RESULTS FOR CAT-152
Presentation at major congress
Melbourn, UK... Cambridge Antibody Technology (LSE: CAT; NASDAQ: CATG) today
announces the twelve month follow-up results from a Phase II clinical trial
using CAT-152 (lerdelimumab; human anti-TGFb 2 monoclonal antibody) in patients
undergoing surgery for glaucoma and cataract. CAT-152 has been designed to
prevent excessive post-operative scarring which is the major reason for long
term failure of glaucoma surgery to lower intraocular pressure.
The trial results will be presented today at the Association for Research in
Vision and Ophthalmology (ARVO) 2002 Annual Meeting in Fort Lauderdale by
consultant ophthalmic surgeon Mr David Broadway.
The Phase II clinical trial studied 56 patients who were undergoing combined
glaucoma and cataract surgery. Patients were randomised to receive either
CAT-152 (36 patients) or matching placebo (20 patients) in a series of four
subconjunctival injections that were given on the day of surgery (both
immediately pre- and post-operatively), the day after surgery and a week after
surgery. The primary objective of the trial was to assess safety and
tolerability of CAT-152 injection in this group of patients. A secondary
objective was exploration of efficacy of CAT-152 in the glaucoma component of
CAT-152 was found to be safe and well tolerated in this trial with no serious
drug-related adverse events and no severe injection site reactions reported.
There was no evidence of increased inflammation in the anterior chamber of the
Intraocular pressure (IOP) was successfully lowered by glaucoma surgery in both
patient groups. Twelve months after operation the achieved IOP was significantly
lower in CAT-152 treated patients (mean value 14.4 mmHg) compared to those
receiving placebo (mean value 16.9 mmHg) (p=0.03). The proportion of patients
achieving IOP below 22mmHg was: CAT-152 100%, placebo 85%; (p = 0.04). Comparing
the distribution of patients who achieved IOP in the ranges _14.5mmHg,
15-17.5mmHg, 18-21.5mmHg and >22mmHg revealed a significant shift to lower
pressures in patients receiving CAT-152 (p=0.05). All these results are
The proportion of patients who required topical medication to manage their IOP
was higher in the placebo group: CAT-152, 11% (4/36) compared with placebo 20%
(4/20). One of these four placebo patients subsequently underwent repeat
glaucoma surgery to control IOP. Intervention after operation with
antimetabolite injections (5-fluorouracil) was identical similar between the two
patient groups with 28% (10/36) of CAT-152 treated patients compared to 30% (6/
20) placebo patients.
Dr David Glover, CAT's Medical Director, commented "The positive outcomes after
one year for CAT-152 treated patients are very similar to those observed in our
earlier clinical trial of CAT-152 in simple glaucoma filtration surgery. And, in
comparison with the previously reported analyses after three and six months of
patient follow-up, these results demonstrate that the benefits of CAT-152
treatment have become apparent with longer term follow-up. Patients treated with
CAT-152 achieved lower IOP and fewer needed to return to topical medication.
Based upon the earlier encouraging findings, a large multi-centre European Phase
II/III clinical trial of CAT-152 in glaucoma surgery has commenced, with
additional clinical trials expected to be announced later this year."
CAT also announces today that, following receipt of a number of expressions of
initial interest from potential partners, it has commenced a process of
assessment and investigation of marketing strategies for CAT-152.
David Glover, Medical Director, will be hosting a conference call at 12pm (BST)
to discuss today's announcement. To participate please call +44 (0)20 8288 8246
and give the password: Cambridge Antibody. An archived audio file will be
available for one week from today on +44 (0) 20 8288 4459 with replay code:
Notes to Editors:
Glaucoma and Glaucoma Surgery
• Glaucoma is the name for a group of eye conditions in which the optic
nerve is damaged at the point where it leaves the eye. The main cause of
this damage is raised pressure inside the eye (intraocular pressure, IOP).
• Glaucoma affects 2% of people aged over 40 years, and the percentage of
people affected rises with age such that 5% of over 65's are affected,
rising to around 8% of over 75's.
• Glaucoma is a major source of blindness. Treatment is generally aimed at
lowering the pressure in the eye to prevent long term damage to eyesight.
Eye drops are the mainstay of treatment but more than 10% of patients
require surgery to control pressure.
• Trabeculectomy is the most commonly performed surgical operation for
glaucoma. Surgery lowers IOP by improving the drainage of fluid in the eye.
• Scarring is the main cause of failure of surgery for glaucoma. There are
no approved treatments to prevent this scarring. CAT has estimated that up
to 250,000 patients undergoing operations in the US and Western Europe each
year could benefit from treatment with CAT-152.
• Quite commonly surgeons will combine surgery for glaucoma with a cataract
extraction and intraocular lens implantation. Both glaucoma and cataract are
conditions that increase in prevalence with increasing age hence they may
co-exist in elderly patients.
• Patients are generally classified as failures of surgery if there is a
need to resume topical medication and/or further surgery is required.
Attainment of IOP levels such as 22mmHg or18mmHg are widely used.
• CAT-152 is a human anti-TGFb 2 monoclonal antibody developed by CAT to
specifically neutralise the cytokine TGFb 2, overactivity of which is
believed to cause scarring in and around the eye. CAT-152 is being developed
as a treatment to prevent scarring in the eye following glaucoma surgery.
• Two year follow up results from a Phase I/IIa clinical trial in 24
patients undergoing simple glaucoma surgery released in April 2001 showed
that the group of patients treated with CAT-152 at the time of surgery
achieved significantly lower intraocular pressure (IOP) than those treated
with placebo. Mean values two years after surgery were 13.6mmHg (CAT-152)
compared to 17.7mmHg (placebo) (p= 0.004). The pressure difference was
apparent despite clear trends for less use of post operative injections and
less use of topical medication in the CAT-152 group. The results were
presented at the Association for Research in Vision in Ophthalmology (ARVO)
2001 conference in Fort Lauderdale, Florida, USA.
• Three month follow-up results of a Phase II clinical trial usingCAT-152 in
combined cataract and glaucoma surgery were announced on 22 August 2001 (see
news release 01/CAT/15) and six month follow-up results were announced on 14
November 2001 (see news release 01/CAT/21).
• Efficacy is measured in terms of reduced need for intervention post
surgery, or in terms of lower IOP.
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 270
• 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 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.
• Six CAT-derived human therapeutic antibodies are at various stages of
clinical trials, with a seventh CAT-derived antibody, D2E7, having been
submitted for regulatory review by Abbott following the completion of Phase
• CAT has alliances with a large number of pharmaceutical and biotechnology
companies to discover, develop and commercialise human monoclonal
antibody-based products. CAT has also licensed its proprietary human phage
antibody libraries to several companies for target validation and drug
discovery. CAT's collaborators include: Abbott , AMRAD, Elan, Genzyme, Human
Genome Sciences, Immunex, Merck & Co, Pharmacia and Wyeth-Ayerst.
• 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
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 CAT's present and future business strategies and the
environment in which CAT will operate in the future. Certain factors that could
cause CAT'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.
This information is provided by RNS
The company news service from the London Stock Exchange