SOUTH SAN FRANCISCO, Calif.,
April 1, 2016 /PRNewswire/
-- Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) today
announced it has completed enrollment for both studies in the FIT
Phase 3 clinical program of fostamatinib, its oral spleen tyrosine
kinase (SYK) inhibitor, in immune thromboycytopenic purpura
(ITP). The first study in this program completed enrollment
at the end of January and the second study has now completed
enrollment. The results from the first study are expected in
the middle of 2016, with the results for the second study expected
shortly thereafter.
Earlier this year Rigel initiated a Phase 2 clinical trial in a
second autoimmune disorder of the blood, autoimmune hemolytic
anemia (AIHA). The purpose of this clinical trial is to
evaluate the safety and efficacy of fostamatinib in patients with
chronic AIHA. This disorder affects an estimated 40,000 Americans,
for whom no approved treatment options currently exist.
FIT Phase 3 Program of Fostamatinib in ITP
The FIT
program consists of two identical studies of approximately 75
patients each. The patients have been diagnosed with persistent or
chronic ITP, and have blood platelet counts consistently below
30,000 per microliter of blood. Study subjects remain on
treatment for up to 24 weeks. The primary efficacy endpoint
of this program is a stable platelet response by week 24 with
platelet counts at or above 50,000 per microliter of blood for at
least four of the final six qualifying blood draws.
Fostamatinib and ITP
In patients with ITP, the immune
system attacks and destroys the body's own blood platelets, which
play an active role in blood clotting and healing. ITP
patients can suffer extraordinary bruising, bleeding and fatigue as
a result of low platelet counts. Current therapies for ITP
include steroids, blood platelet production boosters (TPOs) and
splenectomy. Rigel believes that fostamatinib may address the
autoimmune basis of the disease.
Fostamatinib and AIHA
AIHA is a rare, serious blood
disorder where the immune system produces antibodies that result in
the destruction of the body's own red blood cells. Symptoms
can include fatigue, shortness of breath, rapid heartbeat, jaundice
or enlarged spleen. While no medical treatments are currently
approved for AIHA, physicians generally treat acute and chronic
cases of the disorder with corticosteroids, other
immuno-suppressants, or splenectomy. Research has shown that
inhibiting SYK with fostamatinib may reduce the destruction of red
blood cells.
About Rigel (www.rigel.com)
Rigel Pharmaceuticals,
Inc. is a clinical-stage biotechnology company dedicated to the
discovery and development of novel, targeted drugs in the
therapeutic areas of immunology, oncology and immuno-oncology.
Rigel's pioneering research focuses on signaling pathways that are
critical to disease mechanisms. The company's current clinical
programs include fostamatinib, an oral spleen tyrosine kinase (SYK)
inhibitor, which is in Phase 3 clinical trials for ITP; a Phase 2
clinical trial for autoimmune hemolytic anemia (AIHA); and a Phase
2 clinical trial for IgA nephropathy (IgAN). In addition, Rigel has
two oncology product candidates in Phase 1 development with
partners BerGenBio AS and Daiichi Sankyo.
This press release contains "forward-looking" statements,
including, without limitation, statements related to Rigel's
clinical development plans, including the timing, design and nature
of planned clinical trials and the timing and nature of results of
those trials, as well as the potential activity of fostamatinib
with respect to ITP. 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 "planned," "will," "may,"
"expect," and similar expressions are intended to identify these
forward-looking statements. These forward-looking statements
are based on Rigel's current expectations and inherently involve
significant risks and uncertainties. Actual results and the timing
of events could differ materially from those anticipated in such
forward looking statements as a result of these risks and
uncertainties, which include, without limitation, the availability
of resources to develop Rigel's product candidates, Rigel's need
for additional capital in the future to sufficiently fund Rigel's
operations and research, the uncertain timing of completion of and
the success of clinical trials, risks associated with and Rigel's
dependence on Rigel's corporate partnerships, as well as other
risks detailed from time to time in Rigel's reports filed with
the Securities and Exchange Commission, including its Annual
Report on Form 10-K for the year ended December 31, 2015.
Rigel does not undertake any obligation to update forward-looking
statements and expressly disclaims any obligation or undertaking to
release publicly any updates or revisions to any forward-looking
statements contained herein.
Contact: Raul Rodriguez
Phone: 650.624.1302
Email: invrel@rigel.com
Media Contact: Susan C. Rogers,
Rivily, Inc.
Phone: 650.430.3777
Email: susan@rivily.com
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SOURCE Rigel Pharmaceuticals, Inc.