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Rigel to Focus on Extensive Clinical Pipeline at Upcoming J.P. Morgan Presentation



    Rigel to Focus on Extensive Clinical Pipeline at Upcoming J.P. Morgan
                                 Presentation

R348 for Chronic Dry Eye Initiates Clinical Trial

PR Newswire

SOUTH SAN FRANCISCO, Calif., Jan. 3, 2013

SOUTH SAN FRANCISCO, Calif., Jan. 3, 2013 /PRNewswire/ -- Rigel
Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced that James M. Gower, the
company's chairman and chief executive officer, will present an update on the
company's product portfolio at the J.P. Morgan Healthcare Conference in San
Francisco on January 7, 2013 at 1:30pm Pacific time (see webcast details
below).  In December 2012, Rigel initiated a Phase 1 clinical study of R348, a
topical JAK/SYK inhibitor, as a potential therapeutic for chronic dry eye and
expects to initiate a Phase 2 clinical study in mid 2013. With the addition of
R348, Rigel currently has four programs in clinical development, including
fostamatinib, which is completing its Phase 3 program with partner
AstraZeneca.

"Rigel has created a substantial clinical portfolio with key products now in
Phase 3 and Phase 2 clinical trials," said Mr. Gower. "We expect 2013 to be a
transformational year for Rigel as several of these studies produce clinical
results in succession."

The following is additional information about some of the programs Rigel will
discuss at the J.P. Morgan Conference:

Fostamatinib
Rigel's partner, AstraZeneca, reported that the Phase 3 trials of fostamatinib
in the OSKIRA (Oral SYK Inhibition in Rheumatoid Arthritis) program are
proceeding on course.  The program includes three pivotal studies assessing
the efficacy and safety of fostamatinib in patients with rheumatoid arthritis
(RA). OSKIRA-1 and OSKIRA-2 are independent 12-month studies examining the
effect of fostamatinib on RA patients with inadequate responses to DMARDs,
including methotrexate.  OSKIRA-3 is a 6-month study assessing the effect of
fostamatinib on RA patients who have previously responded inadequately to a
single anti-TNF therapy.  In addition, AstraZeneca is conducting a long-term
extension study looking at the ongoing safety and tolerability of the
investigational drug (OSKIRA-X).

The OSKIRA Phase 3 studies are expected to report top line results in the
first half of 2013.  AstraZeneca expects to submit regulatory filings in the
US and EU for fostamatinib use in combination with a DMARD, based on the
OSKIRA Phase 3 program, in the second half of 2013.

R343, Inhaled SYK Inhibitor
In September 2012, Rigel announced the initiation of SITAR (SYK Inhibition for
Treatment of Asthma with R343) the Phase 2 multi-center, multiple-dose,
double-blind study.  Approximately 270 patients with allergic asthma will be
given R343 or placebo in a dry powder inhaler device and the primary endpoint
will measure each patient's change in FEV1 (the maximum amount of air a person
can forcefully exhale in one second) from baseline to dosing completion. Prior
research conducted on the mechanism of action of R343 suggests that this
single agent may provide therapeutic benefits to counter both acute/early and
chronic/late inflammation mechanisms associated with a wide range of allergic
asthma symptoms. 

Rigel expects results of SITAR in mid 2013. 

R333, Topical Dermatological JAK/SYK Inhibitor
Also in September 2012, Rigel announced the initiation of SKINDLE (SYK Kinase
Inhibition for Discoid Lupus Erythematosus (DLE)). This Phase 2 double-blind,
multi-center study in patients with active discoid skin lesions from DLE or
Systemic Lupus Erythematosus (SLE) will evaluate the primary effectiveness of
R333, a topical JAK/SYK inhibitor, versus placebo following 28 days of
treatment.  Current treatment options for the approximately 300,000 Americans
with this autoimmune disorder of the skin are few, and have toxicities that
further limit their use. 

Rigel expects results of SKINDLE in mid 2013.   

R348, Topical Ophthalmic JAK/SYK Inhibitor
Chronic dry eye, or Keratoconjunctivitis Sicca, is a relatively common
inflammatory condition affecting the lacrimal glands of the eye.  Adults with
this condition may also suffer from SLE, Sjogren's syndrome, RA or other
autoimmune disorders. Chronic dry eye is an irritating and painful syndrome
that, if not well controlled, may be destructive to the cornea.

Since both JAK and SYK are important components in the body's immune and
inflammatory responses, R348's combined JAK/SYK inhibition is expected to
offer relief directly to the eye. A First in Human Phase 1 clinical trial of
R348 eye drops was initiated in patients with chronic dry eye disease in
December 2012.  Rigel expects to move into Phase 2 clinical trials with R348
in mid 2013.

Muscle Programs
In addition to the immunology programs mentioned above, Rigel's R&D teams are
making strides in developing potential small molecule therapeutics for a
variety of muscle wasting and muscle endurance disorders, including those
associated with conditions like peripheral arterial disease, ventilator
atrophy, chronic heart failure, chronic obstructive pulmonary disease and type
2 diabetes mellitus. Preclinical studies with an AMPK Signaling Activator and
a muscle atrophy inhibitor are underway.

Webcast Details
To access the live audio webcast of Rigel's presentation at the J.P. Morgan
Conference or the subsequent archived recording, log on to
http://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. (Nasdaq: RIGL) 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's
productivity has resulted in strategic collaborations with large
pharmaceutical partners to develop and market its product candidates. Current
product development programs include fostamatinib, an oral SYK inhibitor that
is in Phase 3 clinical trials for rheumatoid arthritis with its partner
AstraZeneca; R343, an inhaled SYK inhibitor for asthma and R333, a topical
JAK/SYK inhibitor for discoid lupus – both of which have commenced Phase 2
clinical trials; and, R348, a topical SYK inhibitor in a Phase 1 clinical
trial for the treatment of chronic dry eye. Visit www.rigel.com for more
information.

This press release contains "forward-looking" statements, including, without
limitation, statements related to the progress of the development of
fostamatinib, partnered with AstraZeneca, the timing of certain regulatory
filings for fostamatinib, as well as statements related to dates for the
progress in development of other product candidates, including the expected
timing of commencing clinical trials and obtaining results from ongoing
clinical 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 "potential," "will," "expect," and similar expressions are
intended to identify these forward-looking statements. These forward-looking
statements are based upon Rigel's current expectations and involve risks and
uncertainties. There are a number of important factors that could cause
Rigel's results to differ materially from those indicated by these
forward-looking statements, including, without limitation, the timing and
success of clinical trials and the potential problems that may arise in the
development and approval process, market competition, risks associated with
Rigel's corporate partnerships, as well as other risks detailed from time to
time in Rigel's reports with the Securities and Exchange Commission, including
its Quarterly Report on Form 10-Q for the quarter ended September 30, 2012.
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, Alchemy Consulting, Inc.
Phone: 650.430.3777
Email: susan@alchemyemail.com

SOURCE Rigel Pharmaceuticals, Inc.

Website: http://www.rigel.com
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