Cambridge Antibody - Results of Clinical Trials
06 September 1999 - 6:01PM
UK Regulatory
RNS No 9627f
CAMBRIDGE ANTIBODY TECHNOLOGY GROUP PLC
6 AUGUST 1999
FIRST CLINICAL TRIAL RESULTS FOR CAT-152 IN GLAUCOMA SURGERY
Presented at European Glaucoma Society, 4th September 1999
Melbourn, UK Cambridge Antibody Technology ("CAT") today announced the first
results from its Phase I/IIa clinical trial of CAT-152, a fully human
monoclonal antibody against TGFb2, designed to prevent post-operative scarring
in patients undergoing surgery for glaucoma.
The trial was a double-blind randomised study of CAT-152 versus placebo in 24
patients (16 on CAT-152, 8 placebo) undergoing trabeculectomy at two major UK
eye hospitals. The primary objective was to establish safety and tolerability
of CAT-152 injected at/near the site of operation. Results were presented for
all patients followed for three months post operation.
CAT-152 was shown to be safe and well tolerated in this group of patients:
there were no serious local injection site reactions and no drug-related
serious adverse events were reported. Surgery lowered intraocular pressure in
both groups, but post-operative clinical intervention was less often required
on CAT-152 (3/16), than on placebo (4/8).
Commenting on the results Dr David Glover, CAT's Medical Director, said:
"These results from our first clinical trial of CAT-152 in patients undergoing
glaucoma surgery are encouraging. CAT-152 appears safe and well tolerated,
which was our primary objective. We believe that the reduced need for
post-operative clinical intervention represents our first evidence of
anti-scarring activity in man. We will be following all these patients for a
full year and are planning to build on this result in the larger phase II
trial that is now starting."
Notes
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. Scarring is the main cause of failure of surgery
for glaucoma. There are no approved treatments to prevent this scarring. CAT
has estimated that at least 250,000 patients undergoing operations in the US
and Western Europe each year could benefit from treatment with CAT-152.
Trabeculectomy lowers IOP by improving the drainage of fluid in the eye.
Post-operative clinical intervention is necessary if intraocular pressure
rises again towards pre-operative levels. 5FU (5 fluro uracil) is a potent
anti-cancer drug that may be injected by eye surgeons to try to slow the
scarring process. The need for this usually begins from three to six weeks
after surgery as scar tissue builds up.
CAT-152
CAT-152 (formerly known as 6B1) is a fully human anti-TGFb2 monoclonal
antibody developed by CAT to specifically neutralise the cytokine TGFb2,
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.
Cambridge Antibody Technology (LSE:CAT)
CAT is a UK biotechnology company using its proprietary technologies in fully
human monoclonal antibodies for drug discovery and drug development. Based in
Melbourn, 10 miles south of Cambridge, England, CAT currently employs around
150 people. In March 1997, CAT completed its initial public offering and
listing on the London Stock Exchange, raising approximately #41 million.
CAT has a world-leading platform technology for rapidly isolating fully human
monoclonal antibodies using phage display systems. CAT has an extensive phage
display 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. Three fully human therapeutic antibodies
developed by CAT are at various stages of clinical trials.
CAT has a number of license and collaborative agreements in place with
pharmaceutical and biotechnology companies including: Eli Lilly, Pfizer, BASF
Pharma, Genentech, ICOS Corporation, Genetics Institute/BASF Pharma,
Wyeth-Ayerst, Human Genome Sciences and AstraZeneca.
END
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