SOUTH SAN FRANCISCO, Calif.,
June 12, 2018 /PRNewswire/ -- Rigel
Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced that it will
be presenting an oral presentation on the Phase 2 Stage 1 interim
results for fostamatinib in patients with warm antibody hemolytic
anemia (AIHA) at the 23rd Congress of the European
Hematology Association (EHA) being held June
14-17, 2018, in Stockholm,
Sweden.
Presentation Details:
Title: FOSTAMATINIB, A SPLEEN
TYROSINE KINASE INHIBITOR, FOR THE TREATMENT OF WARM ANTIBODY
AUTOIMMUNE HEMOLYTIC ANEMIA: PRELIMINARY RESULTS OF THE SOAR PHASE
2, MULTICENTER, OPEN-LABEL STUDY
Session Title: Anemia and quality of life
Date & Time: Friday, June 15th, 11:45am – 12:00pm
CEST
Location: Room A10
Abstract Code: S145
Fostamatinib in Autoimmune Hemolytic Anemia
(AIHA)
Rigel is evaluating the safety and efficacy of
fostamatinib in patients with warm antibody AIHA. On
January 31, 2018, the FDA granted
Orphan Drug designation to fostamatinib for the treatment of
patients with AIHA.
The Phase 2, open-label, multi-center, Simon two-stage study
completed enrollment of Stage 1 in 2017. A clinical response in
this trial was defined as achieving a hemoglobin level of greater
than 10 g/dl and at least a 2 g/dl increase from baseline. A total
of 9 of 17 (53%) evaluable patients achieved a response to
fostamatinib treatment, one a late responder in the Stage 1
extension study. The safety profile was consistent with the
existing fostamatinib safety database of over 5,000 patient-years
of exposure. Two deaths were reported during the trial
due to non-treatment related serious adverse events (SAEs) as
determined by the investigators. A third patient experienced a
non-treatment related SAE as determined by the investigator,
recovered and continued on treatment.
Stage 2 follows the same protocol as Stage 1 and will include 20
patients. Rigel currently has 17 sites open for enrollment in
the U.S. and Canada. They are planning European site openings
this year in both the U.K. and France. For more information
please visit: http://www.aihastudy.com/.
Long-term follow-up will provide additional efficacy and safety
data for fostamatinib in patients with AIHA. Rigel plans to
meet with the FDA to determine the regulatory development pathway
of fostamatinib in AIHA.
About AIHA
Autoimmune hemolytic anemia (AIHA) is a
rare, serious blood disorder in which the immune system produces
antibodies that result in the destruction of the body's own red
blood cells. AIHA affects approximately 40,000 adult patients in
the US and can be a severe, debilitating disease. To date, there
are no disease-targeted therapies approved for AIHA, despite the
unmet medical need that exists for these patients.
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
hematologic disorders, cancer and rare diseases. Rigel's pioneering
research focuses on signaling pathways that are critical to disease
mechanisms. The company's first FDA approved product is
TAVALISSE™ (fostamatinib disodium hexahydrate), an oral spleen
tyrosine kinase (SYK) inhibitor, for the treatment of adult
patients with chronic immune thrombocytopenia who have had an
insufficient response to a previous treatment. Rigel's current
clinical programs include Phase 2 studies of fostamatinib in
autoimmune hemolytic anemia and IgA nephropathy. In addition, Rigel
has product candidates in development with partners BerGenBio
AS, Daiichi Sankyo, and Aclaris Therapeutics.
Please see www.TAVALISSE.com for full Prescribing
Information.
Forward Looking Statements
This release contains forward-looking statements relating to,
among other things, Rigel's plans to open clinical trial sites,
enroll patients into trials for AIHA, and to meet with the FDA to
determine the regulatory development pathway of fostamatinib in
AHIA. 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", "expects",
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, risks and
uncertainties associated with the commercialization of TAVALISSE;
risks that the FDA or other regulatory authorities may
make adverse decisions regarding TAVALISSE; risks that TAVALISSE
clinical trials may not be predictive of real-world results or of
results in subsequent clinical trials; risks that TAVALISSE may
have unintended side effects, adverse reactions or incidents of
misuses; the availability of resources to develop Rigel's product
candidates; 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 March 31, 2018. 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: ir@rigel.com
Media Contact: Jessica Daitch
Phone: 917.816.6712
Email: jessica.daitch@syneoshealth.com
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SOURCE Rigel Pharmaceuticals, Inc.