SOUTH SAN FRANCISCO, Calif.,
Jan. 7, 2016 /PRNewswire/
-- Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) today announced
that Raul Rodriguez, the company's
president and chief executive officer, will present a review of
products in development and a financial overview at the upcoming
34th Annual J.P. Morgan Healthcare Conference in
San Francisco on Thursday, January 14 at 9:30 a.m. Pacific Time (see webcast details
below).
Rigel's presentation will include a fostamatinib program update,
including the anticipated completion of the Phase 3 clinical
studies in patients with immune thrombocytopenic purpura (ITP), the
Phase 2 study in IgA nephropathy (IgAN) and plans for a Phase 2
study in autoimmune hemolytic anemia (AIHA).
"There is a great deal to look forward to in 2016 as we prepare
for the Phase 3 study readouts with fostamatinib in ITP," said Mr.
Rodriguez. "We also expect Phase 2 study readouts with
fostamatinib in IgAN and AIHA following the ITP Phase 3 readouts,"
he added.
Product Development Update
- Rigel expects the first of two Phase 3 studies with
fostamatinib for the treatment of ITP to complete enrollment this
month. Rigel expects to report results from this study in the
middle of this year. Results from the second Phase 3 study
are expected shortly thereafter. ITP is an autoimmune disorder of
the blood that is recognized by the FDA as an Orphan Disease, for
which there are limited treatment options.
The physicians who treat this disease and the patients themselves
are hopeful for new therapeutics, particularly since only a
minority of patients respond to any single therapy. Rigel
believes that fostamatinib, which has been extensively studied and
has amassed more than 5,000 patient years of safety and
tolerability data thus far, may be an especially attractive option
for some ITP patients.
- Rigel plans to initiate a Phase 2 proof-of-concept study of
fostamatinib in patients with AIHA in the first quarter of
2016. AIHA is a rare blood disorder that essentially destroys
the body's red blood cells. Research has shown that inhibiting
spleen tyrosine kinase (SYK) with fostamatinib may alleviate this
destructive cascade.
This is an exciting new opportunity for Rigel and fostamatinib. To
date, there are no approved treatments for AIHA, despite the
tremendous medical need that exists for these patients. In
addition, there may be a synergistic benefit for fostamatinib in
ITP and AIHA, since both diseases are autoimmune blood disorders
where a specific blood component (platelets or red blood cells,
respectively) is destroyed and the same hematology community
generally treats both diseases.
- The Phase 2 study of fostamatinib in IgAN, an autoimmune
disease of the kidneys, continues to enroll patients in various
centers throughout Asia, the U.S.
and Europe. The study is on track
to report top line results the second half of 2016. Rigel
plans to seek a pharmaceutical partner with a strong Asian market
presence to collaborate in the design and conduct of follow-on
Phase 3 studies, as well as take responsibility for subsequent
commercialization in that territory.
- Rigel has identified a lead molecule from its IRAK program and
plans to initiate clinical studies by the end of 2016. The program
may provide opportunities in both the oncology and immunology
areas, including acute myeloid leukemia (AML) and its precursor
disease, myelodysplastic syndrome (MDS). Rigel is currently
targeting AML and MDS with different mechanisms of action in
various preclinical projects.
- Leveraging its extensive immunology expertise, Rigel is
continuing to explore novel immuno-oncology approaches to treating
various oncology indications. The first of these resulted in a
collaboration with Bristol-Myers Squibb for TGF beta receptor
kinase inhibitors. Several other projects are currently
underway.
Financial Update
Rigel ended 2015 with approximately $127.0 million in cash, cash equivalents, and
available for sale securities, which it believes will be sufficient
to fund its operations into the third quarter of 2017.
Webcast details
To access the live audio webcast or the subsequent archived
recording, log on to www.rigel.com. Please connect to Rigel's
website several minutes prior to the start of the live webcast to
ensure adequate time for any software download that may be
necessary.
About Rigel (www.rigel.com)
Rigel Pharmaceuticals, Inc. is a clinical-stage
biotechnology company focused on the discovery and development of
novel, small-molecule drugs for the treatment of immune diseases
and cancers. Rigel's pioneering research focuses on signaling
pathways that are critical to disease mechanisms. Rigel currently
has the following product candidates in development: 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; R348, a
topical ophthalmic JAK/SYK inhibitor, in a Phase 2 clinical trial
for dry eye in ocular graft-versus-host disease (GvHD); two
oncology product candidates in Phase 1 development with
partners BerGenBio AS and Daiichi Sankyo; and three
preclinical programs with partners AstraZeneca for R256
in asthma, Bristol-Myers Squibb for TGF beta inhibitors
in immuno-oncology, and Aclaris Therapeutics for certain
JAK inhibitors in dermatology.
Forward Looking Statements
This release contains forward-looking statements relating to,
among other things, the progress, timely execution and timing of
reporting topline data of Phase 3 clinical studies with
fostamatinib in ITP, the Phase 2 clinical study with fostamatinib
in IgAN, the planned Phase 2 clinical study of fostamatinib in
AIHA; the management and advancement of Rigel's other clinical
programs; Rigel's belief that fostamatinib may be an attractive
alternative for patients with ITP; Rigel's ability to successfully
seek a pharmaceutical partner to collaborate in the design and
conduct of follow-on Phase 3 studies, as well as to commercialize
in Asia, the timing, amount and
sufficiency of Rigel's cash, cash equivalents, and available for
sale securities; Rigel's ability to extend the value of Rigel's
pipeline into fields that are beyond its therapeutic focus, the
evaluation of fostamatinib for new treatment indications; and
Rigel's product pipeline and development programs. 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 three months
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
Logo - http://photos.prnewswire.com/prnh/20030226/RIGLLOGO
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/rigel-reviews-recent-progress-and-announces-presentation-at-the-34th-annual-jp-morgan-healthcare-conference-in-san-francisco-300200813.html
SOURCE Rigel Pharmaceuticals, Inc.