SOUTH SAN FRANCISCO,
Jan. 8, 2015 /PRNewswire/
-- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced
that Raul Rodriguez, the company's
president and chief executive officer, will present updated product
development plans and a financial update at the upcoming
33rd Annual J.P. Morgan Healthcare Conference in
San Francisco on Thursday, January 15th at 9:00 a.m. PT (see webcast details
below).
The presentation will focus on two fostamatinib clinical
programs; a Phase 3 clinical study in patients with immune
thrombocytopenic purpura (ITP) and a Phase 2 clinical study for
patients with IgA nephropathy (IgAN); as well as the Phase 2
clinical trial for R348 in patients with dry eye in ocular
graft-vs-host-disease (GvHD).
"Our primary objective this year is the advancement of our
clinical programs with fostamatinib, which are targeted for early
2016 readouts, moving the company towards a potential NDA filing,"
said Mr. Rodriguez. "Additionally, we are pursuing
partnerships for some of our active preclinical projects," he
added.
Product Development Programs Update
- The fostamatinib Phase 3 clinical program for the treatment of
ITP, called FIT, is actively enrolling patients in the United States and Europe. The
program consists of two identical studies that together will
include more than 90 sites and 150 patients. Rigel expects to
separately report top line results of the studies with the first
study reporting in the first quarter of 2016. ITP is an
autoimmune disorder of the blood, for which limited treatment
options are currently available.
- Rigel is initiating a Phase 2 clinical study of fostamatinib in
patients with IgAN, a chronic autoimmune disease of the
kidneys. Rigel expects the study, called SIGN (SYK Inhibition
for Glomerulonephritis), to enroll 75 patients with the disease and
report results in early 2016.
- Approximately 40-60% of the patients who receive stem cell
transplants for malignant hematologic disease develop ocular
GvHD. Rigel's R348, an ophthalmic JAK/SYK inhibitor, is being
evaluated in a Phase 2 study of patients with ocular GvHD to
determine if it reduces inflammation and limits the damage to the
eye tissue caused by the disease. Rigel expects results of
this study in the first quarter of 2016.
Partnerships Update
- AstraZeneca's continued efforts to develop R256, Rigel's
inhaled JAK inhibitor, as a potential treatment for asthma,
triggered a milestone payment of $5.75
million that Rigel earned in December 2014.
AstraZeneca and Rigel entered an exclusive worldwide license
agreement for the global development and commercialization of R256
in June 2012.
- Partners BerGenBio and Daiichi Sankyo are developing Rigel's
AXL kinase inhibitor and an ubiquitin ligase inhibitor,
respectively, for their potential safety and efficacy in treating
various cancers. Both of these molecules are currently in
Phase 1 clinical development.
Financial Update
- Rigel ended 2014 with approximately $143.2 million in cash, cash equivalents, and
available for sale securities. Rigel expects to end 2015 with
cash, cash equivalents, and available for sale securities in excess
of $68.0 million, which it believes
will be sufficient to fund its operations into the fourth quarter
of 2016.
- At the end of 2014, Rigel entered into an agreement to sublease
a portion of its laboratory and administrative office space through
February of 2018. This sublease provides Rigel significant
cost savings over the term of the sublease.
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 drug development
company that discovers and develops novel, small-molecule drugs for
the treatment of inflammatory and autoimmune diseases, as well as
muscle disorders. Rigel's pioneering research focuses on
intracellular signaling pathways and related targets that are
critical to disease mechanisms. Rigel currently has the following
product candidates in development: fostamatinib, an oral SYK
inhibitor, which is in Phase 3 clinical trials for ITP and
initiating a Phase 2 clinical trial for IgAN; R348, a topical
JAK/SYK inhibitor, in a Phase 2 clinical trial for dry eye in
ocular GvHD; two oncology product candidates in Phase 1 development
with partners BerGenBio AG and Daiichi Sankyo; and a
preclinical development program with AstraZeneca for R256 in
asthma.
This release contains forward-looking statements relating to,
among other things, updates on product development programs, the
timing of expected results in its clinical programs, partnerships
and financial information, including Rigel's expected cash
runway. 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, 2014. 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.