Cambridge Antibody - Clinical Trials - Replacement
August 08 1997 - 5:39AM
UK Regulatory
RNS No 4827p
CAMBRIDGE ANTIBODY TECHNOLOGY GROUP PLC
8th August 1997
The issuer has made the following alteration to the
Cambridge Antibody Technology Group PLC
announcement released today.
PLEASE NOTE THE FOLLOWING RELEASE REPLACES THE ONE
PUT OUT EARLIER. THE COMPOUND THAT HAS RECEIVED APPROVAL
IS TGFBeta2 NOT TGFa2 AS IT APPEARED ON THE SCREEN
Cambridge Antibody Technology Group plc
Approval to start clinical trials for
human anti-TGFbeta2 monoclonal antibody
Cambridge Antibody Technology Group plc ("CAT") announces
that it has received approval from the UK Medicines
Control Agency to commence a Phase I/IIa clinical trial
with its anti-TGFbeta2 antibody in patients with early
proliferative vitreo retinopathy. The antibody will be
administered by direct intravitreal injection at the time
of surgery.
Patient enrolment is expected to commence next month at
three major ophthalmology centres in the UK. Up to 45
patients will be enrolled in the trial. The trial is
designed as a placebo controlled rising single dose study
primarily to establish safety and to identify doses for
subsequent efficacy studies.
This will be the first clinical trial initiated by CAT.
Trials of the human anti TNF monoclonal antibody
developed by Knoll (BASF) in conjunction with CAT were
initiated by Knoll earlier this year in patients with
rheumatoid arthritis. Patient recruitment into that
trial is proceeding as planned.
Dr David Chiswell, CAT's Chief Executive Officer, said:
"The proposed use of the anti-TGFb2 antibody
addresses a significant medical need. It is a step
forward for CAT to move into the clinical phase of
product development, and pleasing to achieve this
within the timescale we set at the time of our
listing on the London Stock Exchange in March 1997."
For further information, please contact:
Cambridge Antibody Technology 01763 263233
David Chiswell Chief Executive Officer
John Aston Finance Director
Ludgate Communications 0171 253 2252
Andrew Nicolls
Nicola How
Notes to Editors
CAT
CAT's business is based on a world leading platform
technology for the rapid isolation of human monoclonal
antibodies. This technology has applications both in the
development of antibody-based human therapeutic products
and as a drug discovery tool, particularly in the context
of functional genomics.
TGFbeta2
TGFbeta2 is a multifunctional cytokine that appears in three
isoforms in mammals: TGFbeta1, TGFbeta2 and TGFbeta3. In the
human eye the TGFbeta2 isoform predominates. Of the many
biological activities associated with TGFbeta, much interest
has focused on its role in tissue repair mechanisms.
TGFbeta induces the deposition of extracellular matrix.
Over production of TGFbeta can lead to excessive
extracellular matrix production which is the hallmark of
tissue fibrosis.
Anti TGFbeta2 - opthalmic indications
CAT is developing the human anti-TGFbeta2 monoclonal
antibody for a number of ophthalmic indications; for the
prevention of the recurrence of proliferative vitreo
retinopathy ("PVR") following PVR surgery, for the
prevention of PVR following surgery for retinal
detachment and as an adjunct to glaucoma drainage surgery
to prevent fibrosis at the operated site.
PVR is characterised by the formation of fibrous tissue
in, and in front of, the retina following trauma, retinal
detachment, or in the late stages of diabetic
retinopathy. There is no approved treatment for PVR.
Surgery may be attempted but unfortunately the condition
almost inevitably progresses leading to traction on the
retina causing it to be pulled from its attachment and
thus result in permanent loss of vision or blindness. In
North America and Western Europe combined, CAT has
estimated that surgery to try to prevent the recurrence
of, or to remove, PVR, and/or to re-attach a detached
retina is undertaken on 100,000 patients per year.
CAT's strategy is first to establish the principle of
using anti-TGFbeta2 antibodies in acute indications where a
single dose/course of treatment may be sufficient. If
this principle is established, further clinical studies
will be undertaken to extend their use with the longer
term objective of addressing other ophthalmic conditions
where fibrosis can lead to permanent blindness.
END
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