Cambridge Antibody - Re FDA Trial Permission
November 05 1997 - 10:50AM
UK Regulatory
RNS No 0730p
CAMBRIDGE ANTIBODY TECHNOLOGY GROUP PLC
5th November 1997
Cambridge Antibody Technology Group plc
CAT's collaborative partner Techniclone receives FDA
permission to begin clinical trials with TNT for
malignant glioma
One of CAT's collaborative partners
Techniclone Corporation announced earlier today that
the US Food and Drug Administration (FDA) has allowed
it to begin Phase I Clinical Trials in the US with a
radiolabelled chimaeric (part mouse/part human) TNT
antibody for the treatment of malignant glioma (the
most common primary malignant brain turmour).
The Phase I trials are designed to assess the safety
of TNT in patients who are to have surgical resection
of a recurrent brain tumour. In addition to their
treatment, partients will be given imaging doeses of
TNT to assess safety of the drug in the body.
Endpoints in the study include safety, determination
of the maximum tolerated dose and assessment of the
patient's response to the injected drug.
For further information, please contact:
Cambridge Antibody Technology 01763 263 233
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.
CAT's strategy is to capitalise on the strength of
its platform technology in order to build a diverse
portfolio of antibody-based human therapeutic
products. Clinical trials of two human monoclonal
antibodies developed by CAT have already started in
1997. Phase I/IIa Trials of CAT's anti-TGFBeta 2
monoclonal antibody in patients with early
proliferative vitreo retinopathy have recently
commenced, and earlier this year Phase I/IIa trials
of the human anti-TNFAlpha monoclonal antibody
isolated and developed by CAT in collaboration with
Knoll (BASF) were initiated by Knoll in patients with
rheumatoid arthritis.
CAT will also continue to use its platform technology
as a drug discovery tool, to seek to secure licenses
and collaborative agreements with other
pharmaceutical companies, including genomics companies,
thereby gaining further access to antibody
targets of potential therapeutic interest.
CAT has already entered into a number of licence
and collaborative agreements with pharmaceutical
and biotechnology companies. These include:
technology licences with Genentech, Pfizer and
Eli Lilly; therapeutic antibody licences with Knoll
(BASF), Knoll (BASF)/Genetics Institute and Mitsubishi
Chemical; joint ventures with Techniclone and ObeSys
(with BTG); and a licence agreement with Integra Life
Sciences.
Tumour Necrosis Therapy (TNT)
TNT is a process whereby radiolabelled antibodies
are targeted at necrotic tissue found at the core of
solid tumours. As such it has the potential to kill
growing tumour cells without attaching to
surrounding healthy tissue. TNT acts by binding to
the necrotic cells at the core of the tumour and
irradiating the tumour from the inside.
Techniclone and CAT
Techniclone, a Californian company, and CAT have
a collaborative joint venture to exploit TNT. Revenues
and costs are broadly shared (except that Techniclone
retains manufacturing rights). The programme
involved the development of both chimaeric and human
antibodies.The human antibody, which is in the pre-
clinical stage of development, is intended for
systemic application and in vivo imaging.
END
MSCAVONKBSKARAA
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