Rigel
Pharmaceuticals, Inc. (Nasdaq: RIGL) announced today that it has initiated
enrollment and dosing in a Phase II study to evaluate the efficacy and
safety of its lead product candidate, R788, an oral syk kinase inhibitor,
for the treatment of patients with refractory immune thrombocytopenic
purpura (ITP). ITP is a blood disorder in which the immune system attacks
and destroys platelets in the blood resulting in an abnormally low platelet
count, which can result in easy bruising, bleeding gums, and internal
bleeding.
"R788 has an exciting and novel mechanism of action that targets IgG
signaling, and therefore may treat an underlying cause of the disease,"
said Elliott B. Grossbard, M.D., senior vice president of medical
development of Rigel. "Existing therapies for ITP have significant side
effects and often lack long-term effectiveness."
This single-center, ascending dose proof-of-concept study will evaluate
several doses of R788. The study is expected to enroll patients in the U.S.
who have chronic refractory ITP. The primary endpoint of this study is
improved platelet counts. The study will also measure the safety of R788 in
these patients.
About ITP and R788
Approximately 200,000 people in the U.S. suffer from ITP. Current
first- line treatment for ITP consists primarily of steroids, which are
initially effective in 50-75% of cases, but then show a decline in efficacy
over time. Failure of first-line medical therapy can lead to removal of the
spleen, which poses the risk of other significant complications. Sustained
remission with chronic ITP is infrequent, making the need for new therapies
necessary.
R788 is a novel, oral syk kinase inhibitor that blocks the activation
of mast cells, macrophages and B cells that promote swelling and an
inflammatory response by inhibiting IgG signaling. Usually, IgG antibodies
mediate the destruction of platelets in ITP. Rigel's R788 targets IgG
signaling and so addresses an underlying autoimmune cause of the disease,
rather than stimulating platelet production. In preclinical studies, Rigel
has shown R788 to improve platelet counts in mice treated with
anti-platelet antibodies thus mitigating the disease in an ITP mouse model.
Rigel filed an IND for R788 for the treatment of ITP earlier this year.
In addition to ITP, Rigel is studying R788 in a Phase II study for the
treatment of rheumatoid arthritis.
About Rigel
Rigel is a clinical-stage drug development company that discovers and
develops novel, small-molecule drugs for the treatment of inflammatory
diseases, cancer and viral diseases. Our goal is to file one new
investigative new drug (IND) application in a significant indication each
year. We have achieved this goal since 2002. Our pioneering research
focuses on intracellular signaling pathways and related targets that are
critical to disease mechanisms. Rigel's productivity has resulted in
strategic collaborations with large pharmaceutical partners to develop and
market our product candidates. We have product development programs in
inflammatory/autoimmune diseases such as rheumatoid arthritis,
thrombocytopenia, and asthma and allergy, as well as in cancer.
This press release contains "forward-looking" statements, including
statements related to Rigel's plans with respect to clinical development of
product candidates, the market opportunity for its product candidates, and
expansion of its product portfolio. Any statements contained in this press
release that are not statements of historical fact may be deemed to be
forward-looking statements. Words such as "plans," "intends," "promising,"
"expects," "anticipates" and similar expressions are intended to identify
these forward-looking statements. There are a number of important factors
that could cause Rigel's results to differ materially from those indicated
by these forward-looking statements, including risks associated with the
timing and success of clinical trials and the commercialization of product
candidates, as well as other risks detailed from time to time in Rigel's
SEC reports, including its Form 10-Q for the quarter ended September 30,
2006. Rigel does not undertake any obligation to update forward-looking
statements.
Rigel Pharmaceuticals, Inc.
rigel
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