SOUTH SAN FRANCISCO, Calif., Feb. 3 RigelPharmaceuticals, Inc. (Nasdaq: RIGL) today announced that it will delayfurther partnership discussions regarding R788 until after results from thePhase 2b clinical trials of R788 are available. The company expects thatthese results, involving approximately 650 additional patients, willsubstantially further the understanding of R788's potential and may thereforedrive enhanced economics in a possible deal. The company expects to have acollaboration partnership in place prior to initiating Phase 3 clinicaltrials. Enrollment in the two Phase 2b clinical trials of R788, TASKi2 andTASKi3, are ahead of schedule and the results from these clinical trials areexpected to be available in July and August 2009, respectively. In addition,analysis of the recently completed QT/QTc safety study has confirmed that R788does not elicit a QT/QTc signal.
The company also announced that it has cut its research programs invirology and oncology as well as certain related development andadministrative staff, which resulted in the dismissal of 36 employees orapproximately 20% of the company's workforce. This measure is intended tomaintain the company's emphasis on its active preclinical and clinicalprograms, while conserving the company resources. The company is stillassessing 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, cashequivalents and available-for-sale securities, which the company believes isenough for it to maintain its current development priorities through thesecond quarter of 2010.
"We have decided that postponing the partnership for R788, pending theforthcoming clinical trial results, will better position us to secure anoptimal partnership arrangement for R788," said James M. Gower, Chairman andChief Executive Officer. As for the program cuts, Mr. Gower said, "Rigel hasbeen blessed with a prolific research organization whose members are dedicatedand talented professionals. However, we have come to the point in time, wherewe 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."
Update on the Phase 2b, TASKi2 and TASKi3, Clinical Trials:
Enrollment for the TASKi2 clinical trial of R788 in patients withrheumatoid arthritis (RA) who have previously failed to respond tomethotrexate treatment was completed in December 2008, with 457 patientsrandomized. The smaller TASKi3 clinical trial of R788 is on track to completeenrollment in April 2009 with an expected enrollment of 195 patients with RAwho have previously failed to respond to at least one marketed biologictreatment. Both clinical trials are multi-center, randomized, double-blind,and placebo controlled.
The primary objectives for TASKi2 and TASKi3 are to measure the efficacyof 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 includecomparing higher ACR response rates (ACR 50 and ACR 70), as well as DAS28rates (Disease Activity Score including a 28-joint inspection), in addition tovarious safety measures. TASKi3 will also include measurement of changes inbone morphology using magnetic resonance imaging (MRI) scans as a secondarymeasure. In addition, Rigel will continue to develop R788 in variouslymphomas and is currently conducting a clinical trial in T-cell lymphoma.
Favorable Results in QTc Study for R788
The recently completed double-blind, double-dummy, randomized, positiveand placebo controlled parallel study of the effects of R788 on QT/QTcintervals in healthy subjects showed a favorable result. Under a protocolpre-reviewed by the Food and Drug Administration, a total of 208 healthyvolunteers were divided into four dosage groups and given in a parallel designeither placebo, a standard dose of 100mg bid of R788, a super dose of 300mgbid of R788, or moxifloxacin, (known to elevate QT/QTc intervals in normalhealthy adults). All participants were dosed for four days and were evaluatedfor changes from the time-matched baseline QT/QTc intervals using extractionsfrom continuous Holter monitors. There were no significant effects on theQT/QTc intervals of participants in either the 100mg bid or the 300mg bid R788dosage groups. As expected, the study found that participants in themoxifloxacin group experienced QT/QTc elevations.
Conference Call and Webcast Information:
Rigel will host a conference call today at 8:30 am EST (5:30 am PST) todiscuss the company's business plans and programs. To access the live call,please dial 800-299-7098 (domestic) or 617-801-9715 (international) 10 minutesprior to the start time and use the passcode 29850656. A replay of the callwill be available, in podcast format, at approximately 9:30 a.m. EST onFebruary 3, 2009 until February 10, 2009. To access the replay, please dial888-286-8010 (domestic) or 617-801-6888 (international) and use the passcode98995701. The conference call will also be webcast live and can be accessedfrom Rigel's website at http://www.rigel.com. Please connect to Rigel'swebsite several minutes prior to the start of the live webcast to ensureadequate time for any software downloads that may be necessary.
About Rigel (www.Rigel.com)
Rigel is a clinical-stage drug development company that discovers anddevelops novel, small-molecule drugs for the treatment ofinflammatory/autoimmune diseases and metabolic diseases. Our pioneeringresearch focuses on intracellular signaling pathways and related targets thatare critical to disease mechanisms. Rigel's productivity has resulted instrategic collaborations with large pharmaceutical partners to develop andmarket our product candidates. Rigel has product development programs ininflammatory/autoimmune diseases such as rheumatoid arthritis,thrombocytopenia and asthma, as well as in cancer.
This press release contains forward-looking statements, including, but notlimited to, statements related to the potential efficacy of R788, enrollmentrate in clinical trials of R788, Rigel's plans to pursue clinical developmentof its product candidates, including R788, the market opportunity for itsproduct candidates, expansion of and changes in its product portfolio, Rigel'splans to pursue collaboration partnerships for product candidates, theestimated charge related to the workforce reduction, the sufficiency ofRigel's cash and cash equivalents to fund current and projected developmentand operating plans, and Rigel's cash and cash equivalent balance at December31, 2009. These forward-looking statements are based on the company's currentexpectations and inherently involve significant risks and uncertainties.Rigel's actual results and the timing of events could differ materially fromthose anticipated in such forward looking statements as a result of theserisks and uncertainties, which include, without limitation, risks related tothe development of Rigel's product candidates, including risks related to thetiming and success of clinical trials, and potential problems that may arisein the clinical testing and approval process, and risks related to Rigel'sneed for additional capital. These and other risk factors are discussed under"Risk Factors" in Rigel's SEC reports, including its Form 10-Q for the quarterended September 30, 2008. Rigel undertakes no duty or obligation to update anyforward-looking statements contained in this release as a result of newinformation, future events or changes in its expectations.Contact: Raul Rodriguez Phone: 650.624.1302 Email: [email protected]
Media Contact: Susan C. Rogers, Alchemy Consulting, Inc. Phone: 650.430.3777 Email: [email protected]
SOURCE Rigel Pharmaceuticals, Inc.