Company Oxford Glycosciences PLC
TIDMOGS
Headline Re Agreement
Released 07:01 19 Sep 2002
Number 3693B
For further information please contact:
Oxford GlycoSciences Plc
Xxxxx Xxxxxxxx, Chief Executive Officer
Website: xxx.xxx.xxx
Tel: x00 (0) 0000 000000
Financial Dynamics
UK Media and Investors
Xxxxxxx Xxxxx-Xxxxxx
Xxxxx Xxxxxxx Tel:
x00 (0) 00 0000 0000
US Media and Investors
Xxxxxx Xxxx-Xxxxxxxxxxx
Xxxxxxx Xxxxx-Xxxxx
Tel: x0 - 000 000 0000
For Immediate Release
OGS and FDA to Evaluate Protein Markers
Predictive of Drug Toxicity
Oxford, UK, 19 September 2002 -- Oxford GlycoSciences Plc (LSE: OGS, Nasdaq:
OGSI) today announced that it has entered a Cooperative Research and
Development Agreement (CRADA) with the Center for Drug Evaluation and
Research of the US Food and Drug Administration (FDA). The research
collaboration will aim to identify serum protein biomarkers that could be
useful across species during drug development for early prediction and
evaluation of drug‑induced toxicities to minimize risk of serious
adverse events in clinical trials as well as after drug approval.
Under the terms of the CRADA, titled "Development of Improved Biomarkers
for Early Detection of Myocardial Injury, Vascular Injury, and Liver
Injury", FDA researchers will initiate a programme to develop specific
models of drug-induced histopathologic injury to the myocardium, the
vasculature, and the liver and will produce biological samples suitable
for proteomics analysis. The investigators at OGS will use industrial
scale proteomics technology to analyse those samples and identify serum
markers indicative of specific toxic responses.
Xxxxx Xxxxxxxx, Ph.D., Chief Executive Officer of OGS, commented:
"Drug-induced toxicity is an increasing concern of regulatory authorities
and the pharmaceutical industry in general. For example, drug-induced
damage to the liver is the most common type of toxicity that results in a
treatment being withdrawn from clinical trials or from further marketing.
Similarly, cardiotoxicity is a frequent occurrence in patients undergoing
cancer chemotherapy. However, the currently available biomarkers for these
common types of drug-induced toxicities have limited sensitivity or
predictive value."
He added: "We believe that this research collaboration with the FDA offers
great potential for discovering better biomarkers that may have a
significant impact on the research and development of safer drugs."
Xxxxx Xxxxxxx, Ph.D., Director of the Division of Applied Pharmacology
Research at the Center for Drug Evaluation and Research at the FDA,
commented: "We have been relying on the same set of clinical chemistry
endpoints for routine animal toxicity testing and clinical trial safety
monitoring for over 25 years. The proteomic tools available today are
empowering us to tap into the wealth of genome sequence information to
discover and carefully investigate associations of thousands of proteins
with drug-induced toxicities that are now not easily monitored."
About OGS
OGS has developed a patented technology platform in the emerging field of
proteomics, the comprehensive study of proteins, integrating proteomics
with genomics to create an innovative drug discovery platform. OGS'
proteomics collaborations with major pharmaceutical and biotechnology
companies include Bayer, Pioneer Hi-Bred/DuPont, GlaxoSmithKline and
Pfizer. OGS has drug discovery and development alliances with Medarex,
NeoGenesis and BioInvent and technology development collaborations with
Applera, Cambridge Antibody Technology, Packard BioScience and The
Institute for Systems Biology. OGS has also entered into a joint venture,
Confirmant Limited, to develop the Protein Atlas of the Human Genome.
OGS has drug research discovery programmes in central nervous system,
cancer, infectious disease and glycosphingolipid storage disorders (GSLDs).
In July 2002, OGS' lead compound, ZavescaTM, received a positive opinion
from the Committee for Proprietary Medicinal Products, recommending
approval of the drug in Europe for the treatment of mild to moderate type
1 Gaucher disease in patients for whom enzyme replacement therapy is
unsuitable. Zavesca is undergoing further clinical investigations in
several GLSDs.
About CRADAs
A CRADA is a written agreement between a private company and a government
agency to work together on a project. By entering into a CRADA, the
Federal government and non-Federal partners can optimise their resources
and cost-effectively perform research by sharing the costs of this
research. The collaborating partner agrees to provide funds, personnel,
services, facilities, equipment or other resources needed to conduct a
specific research or development effort while the Federal government
agrees to provide similar resources but not funds directly to the partner.
This release contains forward-looking statements, such as the commercial
potential and success of XXX' collaborations and drug candidates. Factors
that could cause actual results to vary significantly from those expressed
or implied by these and other forward-looking statements include the
success of OGS' research and development strategies, the validity of
its technologies and intellectual property position and strategies,
the medical conclusions on which Zavesca (INN:miglustat) is based and
uncertainties related to the regulatory process.
END
