CAT Annnounce CAT-152 Results
August 22 2001 - 2:00AM
UK Regulatory
RNS Number:8505I
Cambridge Antibody Tech Group PLC
22 August 2001
01/CAT/15
EMBARGOED UNTIL 07.00 BST, 02.00 EST Wednesday 22 August 2001
For Further Information Contact:
Cambridge Antibody Technology Square Mile BSMG Worldwide (Europe)
Tel: +44 (0) 1763 263 233 Tel: +44 (0) 20 7601 1000
David Chiswell, CEO Kevin Smith
David Glover, Medical Director Graham Herring
Rowena Gardner, Head 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 PHASE II CLINICAL TRIAL RESULTS USING
CAT-152 IN COMBINED CATARACT AND GLAUCOMA SURGERY: FINDINGS AT THREE MONTHS
FOLLOWING OPERATION AND TREATMENT
Melbourn, UK... Cambridge Antibody Technology (LSE: CAT; NASDAQ: CATG) today
announced the early results from a Phase II clinical trial using CAT-152
(lerdelimumab; human anti-TGFb 2 monoclonal antibody) in patients undergoing
surgery for glaucoma. CAT-152 has been designed to prevent excessive
post-operative scarring which is the major reason why glaucoma surgery can
fail to lower intraocular pressure in the long term.
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 which 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 demonstration of efficacy of CAT-152.
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
eye.
Intraocular pressure (IOP) was successfully lowered by surgery in both patient
groups. Three months after operation the achieved IOP was lower in patients
receiving CAT-152 (mean value 14.7 mmHg) compared to those receiving placebo
(mean value 15.5 mmHg). IOP of 22 mmHg or lower was achieved by 100% of
CAT-152 treated patients compared to 17 of 20 (85%) of placebo treated
patients. IOP of 18 mmHg or lower was achieved by 31 of 36 (86%) of CAT-152
treated patients compared to 14 of 20 (70%) of placebo treated patients.
Pharmacological intervention (5FU injection or topical IOP lowering
medication) was used in 10 of 36 (28%) of CAT-152 treated patients compared to
4 of 20 (20%) of placebo treated patients. The differences between groups were
not statistically significant.
The results of this trial have been accepted for presentation at the American
Academy of Ophthalmology in New Orleans, November 2001 at which time six
months follow up data will be available.
Commenting on the results, Dr David Glover, CAT's Medical Director said, "
These are early results. The safety data more than justifies proceeding with
further clinical trials. We will be following up these combined glaucoma and
cataract surgery patients for up to 3 years post operatively. The next CAT-152
clinical trial (Phase II/III) will be in simple glaucoma surgery - not
combined with cataract surgery. We expect that trial to enrol around 350
patients in six European countries and to start in the fourth quarter of this
year".
-ENDS-
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
CAT-152 is a fully 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.
Cambridge Antibody Technology (CAT)
CAT is a UK biotechnology company using its proprietary technologies in human
monoclonal antibodies for drug discovery and drug development. Based in
Melbourn, 10 miles south of Cambridge, England, CAT currently employs around
230 people.
CAT is listed on the London Stock Exchange, having raised #41m in its IPO in
March 1997. A further offering in March 2000 raised #93m. Also, CAT's ADRs are
listed on the US NASDAQ National Market.
CAT has an advanced platform technology for rapidly isolating human monoclonal
antibodies using phage display systems. CAT has an extensive phage antibody
library, currently incorporating around 100 billion distinct antibodies. This
library forms the basis for the company's strategy to develop a portfolio of
clinical development programmes and for discovering new drug leads using
functional genomics. Five human therapeutic antibodies developed by CAT are at
various stages of clinical trials.
CAT has a number of licence and collaborative agreements in place with
pharmaceutical and biotechnology companies including: Eli Lilly, Pfizer,
Genentech, ICOS, Genetics Institute, Wyeth-Ayerst, Human Genome Sciences,
Knoll Pharmaceuticals (a subsidiary of Abbott Pharmaceuticals), AstraZeneca,
Pharmacia, Oxford GlycoSciences, Genzyme, Immunex, Zyomyx and Elan.
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.
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