Apitope, the drug discovery and development company focused on treating
the underlying cause of autoimmune diseases, today announces that the
consortium, led by Apitope, which includes GSK Vaccines, Quintiles and
KWS Biotest Limited, has been awarded prestigious Framework Programme 7
(FP7) Health Innovation funding by the European Commission to develop
its Graves' disease therapeutic vaccine, including a Phase I
first-in-man study in Graves' disease patients.
Graves' disease is an immune system disorder that eventually results in
the overproduction of thyroid hormones (hyperthyroidism). While a number
of disorders may result in hyperthyroidism, Graves' disease is the most
common cause affecting 2% of the female population. Symptoms of
hyperthyroidism can include increased heart rate, muscle weakness,
disturbed sleep, and irritability. Patients may also develop bulging
eyes (proptosis). The disease affects multiple systems of the body,
including the skin, heart, circulation and nervous system.
Apitope's antigen-specific disease modifying peptide therapy uses
epitopes designed to shut down the abnormal immune responses to the
causative agent in a highly selective manner, re-instating the normal
immune balance, thereby avoiding global immune suppression. As a result,
the peptides taken into clinical evaluation by Apitope offer the
potential to have limited side effects and a good probability of
Dr. Keith Martin, CEO of Apitope stated: "Graves' Disease is a disease
with serious implications particularly for those with Graves'
orbitopathy who are at risk of blindness. Current treatments for this
disease may result in abnormally low thyroid activity levels, requiring
further medications, and do not treat the fundamental cause of Graves'
disease nor reduce the long term cardiac risks. This funding will allow
a team of experts to develop a much needed therapy that may address the
cause of this serious condition rather than simply treating the symptoms
and removing the need for other medications."
Professor Neil Williams, CSO of KWS BioTest said: "This is a really
exciting approach to the treatment of an important human disease, which
builds on the successes that Apitope has seen in its MS programme. We
are looking forward to applying our expertise in the preclinical
immunology and inflammation areas to help drive the project forwards
into the clinic. The award of the EU grant helps to cement the close
drug discovery partnershp in the consortium."
Apitope International NV, based in Belgium and the UK, is a world-class
drug developer of immunotherapies for the treatment of autoimmune and
allergic diseases, including multiple sclerosis, factor VIII
intolerance, uveitis and Graves' disease. The Company has a patented
discovery platform which enables selection of disease-modifying peptide
therapies for the autoimmune/allergic disease of interest; and has
already generated a pipeline of seven programmes in clinical and
preclinical development, of which the lead programme in multiple
sclerosis is partnered with Merck Serono. The discovery engine selects
Apitopes™ - Antigen Processing Independent epiTOPES. Apitopes are
soluble, synthetic peptides from the human sequence which can
selectively suppress abnormal immune responses and reinstate the normal
immune balance. Stakeholders in the Company include the Wellcome Trust,
LRM, Vesalius Biocapital and the US MS charity, Fast Forward. For more
information on the Company, please visit: www.apitope.com.
Quintiles will act in a comprehensive clinical trial services capacity
for this Apitope-led Consortium. Quintiles (NYSE: Q) is the world's
largest provider of biopharmaceutical development and commercial
outsourcing services with a network of more than 28,000 employees
conducting business in approximately 100 countries. Quintiles has helped
develop or commercialize all of the top-50 best-selling drugs on the
market. Quintiles applies the breadth and depth of its service offerings
along with extensive therapeutic, scientific and analytics expertise to
help our customers navigate an increasingly complex healthcare
environment as they seek to improve efficiency and effectiveness in the
delivery of better healthcare outcomes. To learn more about Quintiles,
please visit www.quintiles.com.
About KWS Biotest
KWS BioTest Ltd is a UK based CRO specialising in offering preclinical
services to pharmaceutical and biotechnology companies ranging from
target validation, lead identification and candidate selection through
to efficacy studies and PK/PD. The company specialises in inflammation,
immunology and infection and works with its customers as a partner in
discovery. Offering a wide range of validated assay models, but also
being able to develop new systems that suit the needs of specific
projects enables KWS to act be a truly flexible service provider. For
more information on the company visit: www.kwsbiotest.com
About Graves' disease
Graves' disease (GD) is an autoimmune disorder caused by auto-reactive T
and B lymphocytes targeting the primary auto-antigen, the Thyroid
Stimulating Hormone Receptor (TSHR).
TSHR is a G-protein-coupled receptor on thyroid follicular cells in the
thyroid gland that stimulates the production of thyroxine (T4) and
triiodothyronine (T3) via a cAMP signal cascade upon binding of its
ligand, the thyroid-stimulating hormone. Upon internalization,
degradation and presentation of the TSHR by APCs, T cells become
activated and interact with auto reactive B cells, which in turn produce
stimulating agonistic auto-antibodies directed against this receptor.
The thyroid-stimulating immunoglobulins bind to the same receptor pocket
as the thyroid-stimulating hormone, activating the TSHR mediated signal
transduction and leading to the production of excess thyroid hormone
from the thyroid gland and thyroid growth.
An overactive thyroid gland can be related with hyperthyroid symptoms
such as increased heart rate, muscle weakness, disturbed sleep, and
irritability. It can also affect the eyes, causing bulging eyes
(proptosis). It affects multiple systems of the body, including the
skin, heart, circulation and nervous system.
There is a strong hereditary component linked to GD; when one identical
twin has Graves' disease, the other twin will have it 25% of the time.
It affects up to 2% of the female population, sometimes appears after
childbirth, and is five to ten times as common in women as in men.
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