SOUTH SAN FRANCISCO, Calif.,
Jan. 10, 2014 /PRNewswire/ -- Rigel
Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced that
James M. Gower, the company's
chairman and chief executive officer, will present updated product
development plans and a financial update at the upcoming
32nd Annual J.P. Morgan Healthcare Conference in
San Francisco on Thursday, January 16th at 9:00 a.m. PT (see webcast details below).
Information will be included about two fostamatinib clinical
programs commencing in the first half of the year, a Phase 3
clinical study in patients with immune thrombocytopenic purpura
(ITP) and a Phase 2 clinical study aimed at treating IgA
nephropathy. Additionally, Rigel announced that it has earned a
milestone payment of $5.75 million
from AstraZeneca for the continued development of R256 in
asthma.
"Rigel has four proprietary projects starting clinical studies
in the next few months, including our Phase 3 program with
fostamatinib in ITP, and we expect results from our Phase 2 study
with R348 in dry eye later this year," said Mr. Gower. "Our
scientific strength gives breadth to our pipeline and 2014 will be
another busy year as we aim to develop treatments for patients who
in some indications have few therapeutic options."
Information about some of the programs Rigel will discuss at the
Conference follows.
Fostamatinib
In the past several years, Rigel has
amassed a significant amount of data on the mechanism of action,
tolerability, safety and efficacy of fostamatinib, its proprietary
oral SYK inhibitor. In September
2013, the company announced that it would evaluate this drug
candidate in patients with ITP, an autoimmune disease of the blood,
which affects an estimated 100,000 Americans. Results of Rigel's
Phase 2 clinical study, published in Blood (volume 113,
number 14), showed that fostamatinib significantly increased
the platelet counts of patients including some who had failed
currently available TPO agents and may offer a treatment approach
that targets the underlying cause of this disease. Rigel
plans to commence a Phase 3 study in this patient population in the
first half of the year.
Immunoglobulin A Nephropathy (IgAN) is an autoimmune disease
that severely affects the functioning of the kidneys. An
estimated 12,000 Americans are diagnosed with this type of
glomerulonephritis each year, with 25% of its victims eventually
requiring dialysis and/or kidney transplantation over time. IgAN is
characterized by the deposition of IgA immune complexes in the
glomeruli of the kidneys leading to an inflammatory response and
subsequent tissue damage that ultimately disrupts the normal
filtering function of the kidneys. By inhibiting SYK in kidney
cells, fostamatinib may block the signaling of IgA immune complex
receptors and arrest or slow destruction of the glomeruli. Rigel
expects to enter a Phase 2 study of fostamatinib in patients with
IgA nephropathy in the spring of 2014.
R348, JAK/SYK Inhibitor for Dry Eye
Approximately 4
million people in the U.S. suffer with dry eye disease, including
an estimated 25% of the patients with rheumatoid arthritis and
systemic lupus eryathematosus. Rigel initiated a Phase 2
clinical study to evaluate the safety and potential efficacy of
R348, a topical ophthalmic JAK/SYK inhibitor, aimed at reducing the
inflammation responsible for the painful symptoms of this
disease. Results of that study are expected in the second
half of 2014.
Additionally, according to an article published by the American
Academy of Ophthalmology, a significant number (22-80%) of patients
with acute or chronic graft vs. host disease (GvHD) develop a
secondary incidence of dry eye (keratoconjunctivitis
sicca). In general, these patients are severely ill and
have a great medical need for a topical therapy that may better
manage their symptoms. In the second quarter of 2014, Rigel
will initiate a Phase 2 study of R348 in patients with dry eye as a
result of primary GvHD.
R118, AMPK Activator for Intermittent
Claudication
Intermittent claudication (IC) refers to the
muscle pain associated with peripheral artery disease (PAD) caused
by either atherosclerosis or inflammation. Patients with IC
have difficulty with simple activities, like walking, and current
therapies do not provide sufficient relief. IC affects more
than 5% of the population age 65 or older, but anyone with PAD may
also suffer the effects of IC. Preclinical evaluation
of R118, an AMPK activator, has shown it to be a central regulator
of lipid and metabolic activity and capable of increasing muscle
endurance. Rigel plans to initiate a Phase 1 trial of R118 in
patients with IC in the first half of 2014.
Partnerships
In addition to the five clinical programs
noted above, Rigel also has products in varying stages of
preclinical and clinical development with three pharmaceutical
partners.
In June 2012, Rigel and
AstraZeneca announced an exclusive worldwide license agreement for
the global development and commercialization of R256, Rigel's
inhaled JAK inhibitor as a potential treatment for asthma.
AstraZeneca is responsible for the development of R256. It's
continued efforts to bring R256 into first-in-human studies
triggered the $5.75 million milestone
payment to Rigel.
Partners BerGenBio and Daiichi Sankyo are developing Rigel's Axl
Kinase inhibitor and a 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 2013 with approximately
$212 million in cash, cash
equivalents, and available for sale securities. Rigel expects
to end 2014 with cash, cash equivalents, and available for sale
securities in excess of $132 million,
which is sufficient to fund its operations through the second
quarter of 2016.
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. The Company currently has five
product candidates in development: fostamatinib, an oral SYK
inhibitor expected to enter Phase 3 clinical trials for ITP and a
Phase 2 clinical trial for IgA nephropathy in the first half of
2014; R348, a topical JAK/SYK inhibitor currently in Phase 2
clinical trials for dry eye; R118, an AMPK activator entering Phase
1 in early 2014; and two oncology product candidates in Phase 1
development with partners BerGenBio and Daiichi Sankyo.
This press release contains "forward-looking" statements,
including, without limitation, statements related to development
plans, the timing of planned clinical trials and results, milestone
payments, and Rigel's ability to fund and maintain its current
development plans into 2016. 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, 2013. 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
SOURCE Rigel Pharmaceuticals, Inc.