Compugen Announces Positive Therapeutic Effect of CGEN-15001 in Animal Model of Rheumatoid Arthritis
December 14 2010 - 7:00AM
Business Wire
Compugen Ltd. (NASDAQ: CGEN) announced today that administration
of CGEN-15001 in an animal model of rheumatoid arthritis (RA)
dramatically ameliorates the clinical symptoms of the disease.
These results, combined with earlier results in an animal model of
multiple sclerosis (MS), strongly support the therapeutic potential
of CGEN-15001 for multiple autoimmune diseases and inflammatory
conditions.
The recently completed study of CGEN-15001 utilized the
collagen-induced arthritis (CIA) animal model. This well accepted
animal model of RA manifests an autoimmune disease with clinical
and pathological similarity to human rheumatoid arthritis. Upon
treatment of mice with established RA disease, impressive
therapeutic effects of CGEN-15001 were observed. Furthermore,
CGEN-15001 showed efficacy similar to that observed through
TNF-alpha blockade with TNFR-Fc, ENBREL®, a widely used biologic
disease modifying anti-rheumatic drug (DMARD). In the study, both
ENBREL® and CGEN-15001 were administered at the same dose and
frequency.
TNF-alpha blockade therapy has revolutionized the treatment of
RA; however, neutralization of TNF in patients receiving TNF
blockers therapy leads to increased risk of infection, and
particularly, of reactivating latent tuberculosis. In addition,
significant proportions of patients do not respond to TNF blockers
and require alternative effective treatments. Thus, novel drugs for
RA that are devoid of such side effects and benefit additional
patient populations remain an unmet clinical need. Among these are
drugs targeting negative co-stimulatory pathways, which are of high
industry interest.
The CIA model of RA is the second well recognized animal model
of autoimmune disease in which CGEN-15001 has shown dramatic
therapeutic potential; previous studies with CGEN-15001
demonstrated similar beneficial effects in an animal model of
multiple sclerosis. Furthermore, in both the animal models of RA
and of MS, the significant clinical potential for this novel
molecule was underscored by the pronounced therapeutic effects
demonstrated when CGEN-15001 was administered in the presence of
established disease. These promising results in the two different
autoimmune disease models further support the development of
CGEN-15001 as a therapeutic agent for autoimmune and inflammatory
diseases, such as multiple sclerosis, rheumatoid arthritis, and
inflammatory bowel disease.
Dr. Richard Williams from the Kennedy Institute of Rheumatology,
Imperial College London UK, a leading scientist in the field of
rheumatoid arthritis who supervised the studies, stated, “These
preliminary results are very impressive, with CGEN-15001 showing
the same level of efficacy as ENBREL®. Furthermore, by testing
CGEN-15001 in established disease we are setting the bar quite
high, as not many compounds are effective in this setting.
Therefore, based on the results seen to date, this molecule
definitely should be further studied as a potential therapy for
multiple autoimmune diseases.”
Dr. Zurit Levine, Compugen’s VP of R&D, stated, “We are
extremely excited about the pronounced efficacy of CGEN-15001 in an
additional autoimmune disease as it substantially broadens the
therapeutic potential for this novel molecule and further validates
our Protein Family Members Discovery Platform. Modulating the
immune system by the use of protein therapeutics targeting
B7/CD28-like negative co-stimulatory pathways, such as CGEN-15001
and its membrane protein form, is an area of extensive research and
has substantial potential in the development of new therapies for
multiple autoimmune and inflammatory diseases, as well as cancer.
The high level of interest in this field led to Compugen’s recent
focus on the B7/CD28 protein family which has resulted thus far in
the discovery of nine novel proteins predicted to be previously
unknown members of this family. CGEN-15001 is the first of these
nine molecules to undergo in vivo validation studies, and has now
exhibited impressive therapeutic activity in well recognized animal
models of both multiple sclerosis and rheumatoid arthritis.”
About CGEN-15001
CGEN-15001 is a novel soluble Fc-fused protein comprised of the
extracellular domain of a novel B7-like negative co-stimulatory
protein, CGEN-15001T, discovered by Compugen through the Protein
Family Members Discovery Platform. In vitro studies have
demonstrated that CGEN-15001 inhibits T cell activation and
differentiation of pro-inflammatory Th1 and Th17 cell types, while
promoting regulatory Th2 responses. Administration of CGEN-15001 in
an animal model of multiple sclerosis (MS) showed dramatic
improvement of disease symptoms and complete abolishment of
spontaneous relapses. CGEN-15001 appears to exert its beneficial
effect by immunomodulation and induction of immune tolerance,
demonstrated by the inhibition of epitope spreading, the underlying
phenomenon which causes the relapsing nature of this disease.
Furthermore, the remarkable beneficial effects observed with
CGEN-15001 in the animal model for multiple sclerosis were also
accompanied by inhibition of infiltration of reactive T lymphocytes
into the central nervous system.
About rheumatoid arthritis
Rheumatoid arthritis (RA) is a chronic autoimmune disease in
which the immune system attacks the synovium (tissue lining the
joint capsule). Autoimmune diseases are illnesses that occur when
the body's tissues are mistakenly attacked by their own immune
system. Rheumatoid arthritis is a common rheumatic disease,
affecting 1% of the population and approximately 1.3 million people
in the United States. This disease is three times more common in
women than in men and can begin at any age, but it most often
starts after 40 years of age and before 60 years of age. The
disease causes chronic inflammation of the joints and can lead to
the destruction of the cartilage, bone, and ligaments, causing
deformity of the joints. It can lead to long-term joint damage,
resulting in chronic pain, loss of function and disability.
Rheumatoid arthritis can also cause inflammation of the tissue
around the joints, as well as in other organs in the body. Because
it can affect multiple organs of the body, rheumatoid arthritis is
referred to as a systemic illness and is also known as rheumatoid
disease.
About the B7/CD28 families of positive and negative
co-stimulatory proteins
Members of the B7/CD28 families have been intensively studied
over the past decade and have brought much excitement to the field
of immune regulation. The activation and development of an adaptive
immune response is initiated by the engagement of a T-cell antigen
receptor with an antigenic peptide-MHC complex. The outcome of this
engagement is determined by both positive and negative
co-stimulatory signals, generated mainly by the interaction between
members of the B7 family ligands and their receptors, mainly
members of the CD28 family. A growing body of evidence indicates
that the dysfunction of immune regulation contributes to the
development of autoimmune diseases.
Positive and negative co-stimulatory pathways play critical
roles in immune regulation and are considered potential targets for
modulating chronic inflammation in autoimmune diseases. To date,
one soluble recombinant fusion protein that selectively blocks the
co-stimulatory signal mediated by the prototype B7/CD28 pathway has
been cleared for marketing in the U.S. for the treatment of
moderate to severe rheumatoid arthritis, and is in clinical trials
for other autoimmune indications. In addition, a number of clinical
and preclinical studies for therapeutic agents targeting these
protein families are underway at various companies.
About Compugen
Compugen is a leading drug and diagnostic product candidate
discovery company. Unlike traditional high throughput trial and
error experimental based discovery, Compugen’s discovery efforts
are based on in silico (by computer) product candidate prediction
and selection utilizing a broad and continuously growing
infrastructure of proprietary scientific understandings and
predictive platforms, algorithms, machine learning systems and
other computational biology tools to address important unmet
therapeutic and diagnostic needs - either for Compugen or its
partners. Compugen’s growing number of collaborations covering the
further development and commercialization of Compugen discovered
product candidates all provide Compugen with potential milestone
payments and royalties on product sales or other forms of revenue
sharing. These collaborations may be entered into before product
candidate discovery is undertaken pursuant to “discovery on demand”
type arrangements, or with respect to existing product candidates,
collaborations can be initiated prior to or at the proof of concept
stage, or after additional preclinical activities have been
undertaken by Compugen. In 2002, Compugen established an affiliate,
Evogene Ltd. (www.evogene.com) (TASE: EVGN.TA), to utilize certain
of the Company’s in silico predictive discovery capabilities in
agricultural biotechnology. For additional information, please
visit Compugen's corporate website at www.cgen.com.
This press release may contain "forward-looking statements"
within the meaning of the Private Securities Litigation Reform Act
of 1995. These statements include words such as “may”, “expects”,
“anticipates”, “believes”, and “intends”, and describe opinions
about future events. These forward-looking statements involve known
and unknown risks and uncertainties that may cause the actual
results, performance or achievements of Compugen to be materially
different from any future results, performance or achievements
expressed or implied by such forward-looking statements. Some of
these risks are: changes in relationships with collaborators; the
impact of competitive products and technological changes; risks
relating to the development of new products; and the ability to
implement technological improvements. These and other factors are
identified and more fully explained under the heading "Risk
Factors" in Compugen's annual reports filed with the Securities and
Exchange Commission.
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