SOUTH SAN FRANCISCO, Calif.,
Dec. 8, 2017 /PRNewswire/
-- Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) today
announced that the one-year efficacy and safety results from its
FIT Phase 3 clinical program of fostamatinib for chronic or
persistent immune thrombocytopenia (ITP) will be featured in an
oral presentation at the 2017 American Society of Hematology Annual
Meeting being held in Atlanta, GA
from December 9 to December 12,
2017.
During the presentation, James B.
Bussel, M.D., professor emeritus of pediatrics at Weill
Cornell Medicine and the principal study investigator on the FIT
Phase 3 program who has served as a member of an
advisory/scientific board for Rigel Pharmaceuticals, will share an
overview of the FIT clinical program.
Oral Presentation Details:
TITLE: Long-Term Maintenance of Platelet Responses in Adult
Patients with Persistent/Chronic Immune Thrombocytopenia Treated
with Fostamatinib: 1-Year Efficacy and Safety Results
Session Name: 311. Disorders of Platelet Number or Function: ITP:
clinical aspects
Session Date: Saturday, December 9,
2017
Session Time: 7:30 AM - 9:00 AM EST
Presentation Time: 8:15 AM EST
Location: Georgia World Congress Center, Bldg B, Lvl 3, B304-B305 (Atlanta, GA)
About Fostamatinib in ITP
Fostamatinib, an
oral spleen tyrosine kinase (SYK) inhibitor, is an investigational
drug for adult patients with chronic or persistent immune
thrombocytopenia (ITP). The New Drug Application (NDA) for
fostamatinib for adult patients with chronic or persistent ITP,
which was previously granted Orphan Drug designation, is currently
under review by the U.S. Food and Drug Administration with a
Prescription Drug User Fee Act (PDUFA) goal date of April 17, 2018. The conditionally approved
proprietary name for fostamatinib (as confirmed by the FDA) is
TAVALISSETM.
The NDA is supported by data from the FIT Phase 3 clinical
program, 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 (TPOs) 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 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 and the FDA has accepted for review, an NDA 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 enrollment and results of on-going clinical trials and
the results of the FDA's review of Rigel's NDA for fostamatinib in
patients with chronic or persistent 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 FDA may interpret Rigel's findings
differently, which could result in
the FDA not approving the
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; market
competition; 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 September 30, 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.