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Rigel To Present Phase 2 Results for Fostamatinib in Autoimmune Hemolytic Anemia at EHA

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Wednesday, June 13, 2018

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SOUTH SAN FRANCISCO, Calif. - Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) 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.

Presentation Details:
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.

About 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 
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.

Contacts:
Raul Rodriguez

Phone: 650.624.1302
Email: ir@rigel.com

Media Contact: Jessica Daitch
Phone: 917.816.6712
Email: jessica.daitch@syneoshealth.com

Source: Rigel Pharmaceuticals, Inc.
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