SOUTH SAN FRANCISCO, Calif.,
Jan. 28, 2016 /PRNewswire/
-- Rigel Pharmaceuticals, Inc. (NASDAQ: RIGL) today announced
that the first of two Phase 3 clinical studies of fostamatinib in
immune thrombocytopenic purpura (ITP) completed patient enrollment
this month. The results from this first study are expected in the
middle of 2016, with the results from the second study expected
shortly thereafter.
The FIT program consists of two identical studies of 75 patients
each. The patients will 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 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. For additional
information about the FIT studies, visit
http://tinyurl.com/RigelPhase3ITP.
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.
The U.S. Food and Drug Administration has granted Orphan Drug
designation to fostamatinib for the treatment of patients with
ITP. For additional information about ITP, visit
http://www.rigel.com/index.php/pipeline/fostamatinib-itp/.
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 IgA
nephropathy (IgAN); and a planned Phase 2 clinical trial for
autoimmune hemolytic anemia (AIHA) in 2016. 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, market competition, 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 Quarterly Report on Form 10-Q for
the quarter ended September 30, 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.