SOUTH SAN FRANCISCO, Calif.,
June 22, 2017 /PRNewswire/
-- Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) today
announced that data from its FIT Phase 3 clinical program
evaluating the safety and efficacy of TAVALISSE™ (fostamatinib
disodium) in patients with chronic or persistent immune
thrombocytopenia (ITP) will be presented on Saturday, June 24, 2017, from 12:30 - 12:45pm (CEST) at the European Hematology
Association 22nd Annual Congress (EHA) in Madrid, Spain. Earlier this week, Rigel
announced the FDA has set an expected action date of April 17, 2018, to complete its review of
fostamatinib under the Prescription Drug User Fee Act (PDUFA).
The FDA previously granted Orphan Drug designation to
fostamatinib for the treatment of patients with ITP.
The oral presentation, entitled "Treatment of Primary Adult
Chronic Immune Thrombocytopenia (CITP) with Fostamatinib, an Oral
SYK Inhibitor: Results of Two Randomized, Placebo-Controlled Phase
3 Studies," is authored by James B.
Bussel, M.D., professor of Pediatrics, Pediatrics in
Obstetrics and Gynecology, and Pediatrics in Medicine at Weill
Cornell Medical College and the principal study investigator on the
FIT Phase 3 program, and colleagues.
The details are as follows:
Session Title: Acquired and inherited platelet disorders
Oral Presentation: "Treatment of Primary Adult Chronic Immune
Thrombocytopenia (CITP) with Fostamatinib, an Oral SYK Inhibitor:
Results of Two Randomized, Placebo-Controlled Phase 3 Studies"
Date: Saturday, June 24, 2017
Time: 12:30 - 12:45pm CEST
Location: IFEMA - Feria de Madrid: Avda. del Partenón, 5,
28042 Madrid, Spain, Room N101
Final Abstract Code: S435
About the FIT Phase 3 Clinical Program
The recently
accepted NDA is supported by data from the Phase 3 clinical program
for fostamatinib in ITP, which was comprised of three studies, two
randomized placebo-controlled studies (Studies 047 and 048) and an
open-label extension study (Study 049). Together with an initial
proof of concept study, the NDA included 163 ITP patients. Across
all indications, fostamatinib has been evaluated in over 4,600
subjects. Data from all studies, including preclinical
evaluation and drug manufacturing data, were included in the NDA
submission.
About 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. Common symptoms of
ITP are excessive bruising and bleeding. People suffering
with chronic ITP may live with increased risk of severe bleeding
events that can result in serious medical complication, or even
death. Current therapies for ITP include steroids, blood
platelet production boosters (TPO-RAs) and splenectomy. However,
not all patients are adequately treated with existing therapies. As
a result, there remains a significant medical need for additional
treatment options for patients with ITP.
About TAVALISSE™ (fostamatinib disodium)
TAVALISSE™ is
an oral investigational drug candidate designed to inhibit SYK
kinase, a key signaling member in the immune process that leads to
platelet destruction in ITP. Unlike other therapies that modulate
the immune system in different ways or stimulate platelet
production, fostamatinib may address an underlying autoimmune cause
of ITP by impeding platelet destruction.
About Rigel (www.rigel.com)
Rigel Pharmaceuticals, Inc. is a biotechnology company dedicated to
discovering, developing and providing novel small molecule drugs
that significantly improve the lives of patients with immune and
hematological disorders, cancer and rare diseases. Rigel's
pioneering research focuses on signaling pathways that are critical
to disease mechanisms. The company's current clinical programs
include clinical trials of fostamatinib, an oral spleen tyrosine
kinase (SYK) inhibitor, in a number of indications. Rigel has
submitted an NDA to the FDA for fostamatinib in patients with
chronic or persistent immune thrombocytopenia (ITP). In addition,
Rigel has product candidates in development with partners BerGenBio
AS, Daiichi Sankyo and Aclaris Therapeutics.
Forward Looking Statements
This release contains
forward-looking statements relating to, among other things, the
timing of a response from the FDA to our NDA submission. 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 "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 FDA may interpret Rigel's
findings differently, which could result in the FDA not
approving any submitted NDA; 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; 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
period ended March 31, 2017. 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: Jessica Daitch
Phone: 917.816.6712
Email: jessica.daitch@inventivhealth.com
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SOURCE Rigel Pharmaceuticals, Inc.