Rigel To Present Phase 2 Results for Fostamatinib in Autoimmune Hemolytic Anemia at EHA
SOUTH SAN FRANCISCO, Calif., June 12, 2018 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced that it will be presenting an oral presentation on the Phase 2 Stage 1 interim results for fostamatinib in patients with warm antibody hemolytic anemia (AIHA) at the 23rd Congress of the European Hematology Association (EHA) being held June 14-17, 2018, in Stockholm, Sweden.
Title: FOSTAMATINIB, A SPLEEN TYROSINE KINASE INHIBITOR, FOR THE TREATMENT OF WARM ANTIBODY AUTOIMMUNE HEMOLYTIC ANEMIA: PRELIMINARY RESULTS OF THE SOAR PHASE 2, MULTICENTER, OPEN-LABEL STUDY
Session Title: Anemia and quality of life
Date & Time: Friday, June 15th, 11:45am – 12:00pm CEST
Location: Room A10
Abstract Code: S145
Fostamatinib in Autoimmune Hemolytic Anemia (AIHA)
Rigel is evaluating the safety and efficacy of fostamatinib in patients with warm antibody AIHA. On January 31, 2018, the FDA granted Orphan Drug designation to fostamatinib for the treatment of patients with AIHA.
The Phase 2, open-label, multi-center, Simon two-stage study completed enrollment of Stage 1 in 2017. A clinical response in this trial was defined as achieving a hemoglobin level of greater than 10 g/dl and at least a 2 g/dl increase from baseline. A total of 9 of 17 (53%) evaluable patients achieved a response to fostamatinib treatment, one a late responder in the Stage 1 extension study. The safety profile was consistent with the existing fostamatinib safety database of over 5,000 patient-years of exposure. Two deaths were reported during the trial due to non-treatment related serious adverse events (SAEs) as determined by the investigators. A third patient experienced a non-treatment related SAE as determined by the investigator, recovered and continued on treatment.
Stage 2 follows the same protocol as Stage 1 and will include 20 patients. Rigel currently has 17 sites open for enrollment in the U.S. and Canada. They are planning European site openings this year in both the U.K. and France. For more information please visit: http://www.aihastudy.com/.
Long-term follow-up will provide additional efficacy and safety data for fostamatinib in patients with AIHA. Rigel plans to meet with the FDA to determine the regulatory development pathway of fostamatinib in AIHA.
Autoimmune hemolytic anemia (AIHA) is a rare, serious blood disorder in which the immune system produces antibodies that result in the destruction of the body's own red blood cells. AIHA affects approximately 40,000 adult patients in the US and can be a severe, debilitating disease. To date, there are no disease-targeted therapies approved for AIHA, despite the unmet medical need that exists for these patients.
About Rigel (www.rigel.com)
Rigel Pharmaceuticals, Inc., is a biotechnology company dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with immune and hematologic disorders, cancer and rare diseases. Rigel's pioneering research focuses on signaling pathways that are critical to disease mechanisms. The company's first FDA approved product is TAVALISSE™ (fostamatinib disodium hexahydrate), an oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. Rigel's current clinical programs include Phase 2 studies of fostamatinib in autoimmune hemolytic anemia and IgA nephropathy. In addition, Rigel has product candidates in development with partners BerGenBio AS, Daiichi Sankyo, and Aclaris Therapeutics.
Please see www.TAVALISSE.com for full Prescribing Information.
Forward Looking Statements
This release contains forward-looking statements relating to, among other things, Rigel's plans to open clinical trial sites, enroll patients into trials for AIHA, and to meet with the FDA to determine the regulatory development pathway of fostamatinib in AHIA. 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 "plans", "expects", 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, risks and uncertainties associated with the commercialization of TAVALISSE; risks that the FDA or other regulatory authorities may make adverse decisions regarding TAVALISSE; risks that TAVALISSE clinical trials may not be predictive of real-world results or of results in subsequent clinical trials; risks that TAVALISSE may have unintended side effects, adverse reactions or incidents of misuses; the availability of resources to develop Rigel's product candidates; market competition; 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 period ended March 31, 2018. 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
Media Contact: Jessica Daitch
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SOURCE Rigel Pharmaceuticals, Inc.
Released June 12, 2018