As of March 2012, Rigel has eight novel small molecule programs in clinical or preclinical development, including Rigel's partner, AZ's Phase 3 clinical trial program (OSKIRA) with fostamatinib in patients with RA. AZ has recently announced that it expects to file for a new drug application for fostamatinib with the U.S. Food and Drug Administration in the second half of 2013.
Source: press release, 3/06/12. http://ir.rigel.com/phoenix.zhtml?c=120936&p=irol-newsArticle&ID=1669348...
James M. Gower, Chairman of the Board and CEO, commented on the Fostamatinib program for RA. He stated, "The furthest ahead is a program in phase III which is our oral Syk kinase inhibitor for RA. AstraZeneca is finishing up phase III trials this year. They have anounced they have projected to file next year."
Source: 32nd Annual Cowen and Company Health Care Conference, 3/05/12.
AZ recently reported that their Phase 3 clinical development program (OSKIRA) to investigate fostamatinib as a treatment for rheumatoid arthritis is progressing well. AZ expects the first set of data in the second half of 2012 and expects to remain on track to meet the planned US and European new drug application (NDA) filing dates in 2013. AZ also announced that in the first quarter of 2011 they had commenced a Phase 2b clinical trial (OSKIRA 4) that explores fostamatinib as a monotherapy in rheumatoid arthritis. This trial will provide important information on the profile of fostamatinib without concomitant treatment with a disease-modifying anti-rheumatic drug (DMARD).
Source: press release, 8/02/11. http://ir.rigel.com/phoenix.zhtml?c=120936&p=irol-newsArticle&ID=1591684...
Raul R. Rodriguez, President and COO, responded to a question regarding data flow for Fostamatinib. He stated, "No additional data review is planned for those ongoing studies between now and the showing of the data. So, we are not planning on having any interim looks, there isn't any interim look planned or safety looks that are planned. So, we are not likely to see that until we see the actual read-outs of the clinical trials. We do not have a specific date of when we will have or AZ does not have a specific date as to when they will issue the data on the phase III program but given that they are planning a NDA filing in 2013 you can back up from there and have some idea yourselves in terms of when that might come along. As we get closer to some of these dates we'll have a better more fine estimate of what quarter or what half year things will occur as we get a little bit closer. As things progress, I think we will have a little bit better handle on it. As things progress in terms of enrollment too, I think they will be able to give better guidance in terms of when we can expect the data."
Source: Wells Fargo Securities Healthcare Conference, 6/23/11.
SOUTH SAN FRANCISCO, Calif., Sept 29, 2010 /PRNewswire via COMTEX/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced that it has earned $25 million from AstraZeneca for the fulfillment of two major milestones in the agreement the two companies have regarding the clinical development of fostamatinib (R788), a novel oral syk inhibitor. The first milestone is for initiation of the phase 3 clinical program with fostamatinib in patients with rheumatoid arthritis (RA) that was announced by AstraZeneca earlier today. The second milestone marks the completion of the transfer of the fostamatinib long-term open label extension study from Rigel to AstraZeneca.
Source: press release, 9/29/10. http://ir.rigel.com/phoenix.zhtml?c=120936&p=irol-newsArticle&ID=1475814...
OSKIRA-1 - A Phase III, Multi-centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate
Study Start Date: September 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Source: clinical trials.gov. http://clinicaltrials.gov/ct2/show/NCT01197521?term=Fostamatinib&rank=7
|Fostamatinib disodium, (R788) (3) RA||Rheumatology||Rheumatoid Arthritis (RA)||Syk kinase inhibitor||Syk kinase|
Mechanism of action: R788, a SM-inhibitor, disrupts IgG receptor signaling in macrophages and B-cells that is known to promote swelling and the inflammatory response via syk kinase inhibition.
Phase of Development: III
Event Type: Data: Phase III trial results
Dates: 2012-12-01 - 2013-01-31