Therapeutic Antibodi - ReTransplant Clinical Program
01 October 1997 - 5:30PM
UK Regulatory
RNS No 5845a
THERAPEUTIC ANTIBODIES INC
1st October 1997
THERAPEUTIC ANTIBODIES INC.
ANNOUNCES START OF TRANSPLANT CLINICAL PROGRAM
LONDON, 1 October, 1997 - Therapeutic Antibodies Inc. (TAb)
announced today that the U.S. Food and Drug Administration
(FDA) has cleared TAb's Investigational New Drug (IND)
application for the development of CytoTAbTM in renal
transplant patients. This indication involves the prevention
of the drug-induced side effects frequently seen in the
treatment of kidney transplant rejection. As a result, TAb
will now proceed with a clinical study program in the United
States.
Many kidney transplant patients suffer acute rejection episodes
which are often treated with an antilymphocyte therapy, such as
Orthoclone OKT(registered trademark)3. This treatment may
itself be associated with side effects stemming from release
into the circulation of large quantities of Tumor Necrosis
Factor alpha (TNFa). CytoTAbTM is a highly purified polyclonal
antibody which has demonstrated its ability to neutralize TNF
in patients (New England Journal of Medicine, August, 1996).
TAb has acquired the exclusive patent rights covering the use
of antibodies for this indication through a licensing agreement
with the Nutrition Toxicology and Environmental Research
Institute Maastricht (NUTRIM) in the Netherlands.
Martin S. Brown, Chairman and CEO of TAb, said:
"We are very pleased that this IND was rapidly cleared and we
will shortly begin the clinical trials phase of development for
this particular indication. The economic implications of this
program are underlined by the fact that approximately 30,000
kidney transplant procedures are performed in the United States
and Europe annually, with a rejection rate of between 40 and 60
per cent."
Therapeutic Antibodies Inc., is an international
biopharmaceutical group specializing in research, development
and production of highly purified polyclonal antibodies for
treatment of diseases and other life-threatening conditions for
which satisfactory therapies have generally not previously
existed.
TAb's shares are listed on the London Stock Exchange. An
electronic version of this news release, as well as additional
information about Therapeutic Antibodies Inc. is available on
the Company's home page at: "http://www.tab.co.uk".
Enquiries:
Therapeutic Antibodies Inc Martin Brown
001 615-327-1027 Saul Komisar
Brunswick Stephen Breslin
0171 404-5959 Frank De Maria
END
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