Full Press Release Details
Rigel Expects R788 Partnership After Phase 2b Clinical Trials Results
Company Expects Trial Results to Lead to Enhanced Economics, Trims
SAN FRANCISCO, Calif., February 3, 2009 Rigel Pharmaceuticals, Inc.
(Nasdaq: RIGL) today announced that it will delay further partnership
discussions regarding R788 until after results from the Phase 2b clinical trials
of R788 are available. The company
expects that these results, involving approximately 650 additional patients,
will substantially further the understanding of R788 s potential and may
therefore drive enhanced economics in a possible deal. The company expects to
have a collaboration partnership in place prior to initiating Phase 3 clinical
trials. Enrollment in the two Phase 2b clinical trials of R788, TASKi2 and
TASKi3, are ahead of schedule and the results from these clinical trials are
expected to be available in July and August 2009, respectively. In addition, analysis of the recently
completed QT/QTc safety study has confirmed that R788 does not elicit a QT/QTc
company also announced that it has cut its research programs in virology and
oncology as well as certain related development and administrative staff, which
resulted in the dismissal of 36 employees or approximately 20% of the company s
workforce. This measure is intended to maintain the company s emphasis on its
active preclinical and clinical programs, while conserving the company
resources. The company is still assessing the restructuring and other charges
associated with this measure, which is expected to be predominantly recorded in
the first quarter of 2009. As of December 31, 2008, the company had $134.5
million in cash, cash equivalents and available-for-sale securities, which the
company believes is enough for it to maintain its current development
priorities through the second quarter of 2010.
have decided that postponing the partnership for R788, pending the forthcoming
clinical trial results, will better position us to secure an optimal
partnership arrangement for R788, said James M. Gower, Chairman and Chief
Executive Officer. As for the program
cuts, Mr. Gower said, Rigel has been blessed with a prolific research
organization whose members are dedicated and talented professionals. However, we have come to the point in time,
where we can no longer continue to support all of the programs we have
generated. The company needs to focus on
moving our most advanced projects forward, including, in the case of R788,
potentially into Phase 3 clinical trials.
on the Phase 2b, TASKi2 and TASKi3,
for the TASKi2 clinical trial of R788 in
patients with rheumatoid arthritis (RA) who have previously failed to respond
to methotrexate treatment was completed in December 2008, with 457
patients randomized. The smaller TASKi3 clinical trial of R788 is on track to complete
enrollment in April 2009 with an expected enrollment of 195 patients with
RA who have previously failed to respond to at least one marketed biologic
treatment. Both clinical trials are
multi-center, randomized, double-blind, and placebo controlled.
primary objectives for TASKi2 and TASKi3 are to measure the efficacy of R788 at 6 months and
3 months, respectively, as determined by ACR20 scores (American College of
Rheumatology responder rates showing a minimum of 20% improvement in RA
symptoms and pain). Secondary objectives
will include comparing higher ACR response rates (ACR 50 and ACR 70), as well
as DAS28 rates (Disease
Activity Score including a 28-joint inspection), in addition to various safety
will also include measurement of changes in bone morphology using magnetic
resonance imaging (MRI) scans as a secondary measure. In addition, Rigel will continue to develop
R788 in various lymphomas and is currently conducting a clinical trial in
Results in QTc Study for R788
recently completed double-blind, double-dummy, randomized, positive and placebo
controlled parallel study of the effects of R788 on QT/QTc intervals in healthy
subjects showed a favorable result.
Under a protocol pre-reviewed by the Food and Drug Administration, a
total of 208 healthy volunteers were divided into four dosage groups and given
in a parallel design either placebo, a standard dose of 100mg bid of R788, a
super dose of 300mg bid of R788, or moxifloxacin, (known to elevate QT/QTc
intervals in normal healthy adults). All
participants were dosed for four days and were evaluated for changes from the
time-matched baseline QT/QTc intervals using extractions from continuous Holter
monitors. There were no significant
effects on the QT/QTc intervals of participants in either the 100mg bid or the
300mg bid R788 dosage groups. As
expected, the study found that participants in the moxifloxacin group
experienced QT/QTc elevations.
Call and Webcast Information:
Rigel will host a conference
call today at 8:30 am EST (5:30 am PST) to discuss the company s business plans
and programs. To access the live call, please dial
800-299-7098 (domestic) or 617-801-9715 (international) 10 minutes prior to the
start time and use the passcode 29850656. A replay of the call will be
available, in podcast format, at approximately 9:30 a.m. EST on February 3,
2009 until February 10, 2009. To access the replay, please dial
888-286-8010 (domestic) or 617-801-6888 (international) and use the passcode
98995701. The conference call will also be webcast live and can be accessed
from Rigel s website at 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 downloads that may be necessary.
Rigel (www.Rigel.com)
Rigel is a clinical-stage
drug development company that discovers and develops novel, small-molecule
drugs for the treatment of inflammatory/autoimmune diseases and metabolic
diseases. Our 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 our product candidates. Rigel has product
development programs in inflammatory/autoimmune diseases such as rheumatoid
arthritis, thrombocytopenia and asthma, as well as in cancer.
press release contains forward-looking statements, including, but not limited
to, statements related to the potential efficacy of R788, enrollment rate in
clinical trials of R788, Rigel s plans to pursue clinical development of its
product candidates, including R788, the market opportunity for its product
candidates, expansion of and changes in its product portfolio, Rigel s plans to
pursue collaboration partnerships for product candidates, the estimated charge
related to the workforce reduction, the sufficiency of Rigel s cash and cash