SOUTH SAN FRANCISCO, Calif., Nov. 1, 2018 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), today announced that two-year safety and efficacy data from its FIT Phase 3 extension study (FIT3) for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment has been accepted for an oral presentation at the 60th American Society of Hematology (ASH) Annual Meeting & Exposition to be held December 1-4, 2018, in San Diego, CA. Additionally, data from the open-label extension period of the SOAR Phase 2 clinical study in patients with warm antibody autoimmune hemolytic anemia (AIHA) and data from the exploratory analyses of the relationship between anti-platelet antibodies in adult patients with ITP and their response to fostamatinib1 have been accepted for two separate poster presentations.
Fostamatinib disodium hexahydrate is an oral drug designed to inhibit spleen tyrosine kinase (SYK), a key signaling component of the body's immune process that is believed to lead to platelet destruction in ITP and red blood cell destruction in AIHA. Fostamatinib is commercially available in the U.S. under the brand name TAVALISSE™ (fostamatinib disodium hexahydrate) tablets, which is the first and only SYK inhibitor indicated for the treatment of thrombocytopenia in adult patients with chronic ITP who have had an insufficient response to a previous treatment. Fostamatinib1 is currently being investigated in AIHA, 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, and for which there are no approved therapies.
Oral Presentation
Abstract #736
Two-Year Safety and Efficacy Outcomes with Fostamatinib in Adult Patients with Immune Thrombocytopenia (ITP): Open-Label Extension to Phase 3 Trial Program
Session Name: 311. Disorders of Platelet Number or Function: Advances in the Treatment of ITP
Presenter: Anne-Marie Duliege, MD, Executive Vice President and Chief Medical Officer
Date: Monday, December 3, 2018
Presentation Time: 3:30 PM PST
Location: San Diego Convention Center, Room 31B
Poster Presentations
Abstract #3612
Fostamatinib1, a Spleen Tyrosine Kinase Inhibitor, for the Treatment of Warm Antibody Autoimmune Hemolytic Anemia: Initial Results of the Multicenter, Open-Label Extension Period of the SOAR Phase 2 Study
Session Name: 101. Red Cells and Erythropoiesis, Structure and Function, Metabolism, and Survival, Excluding Iron: Poster III
Date: Monday, December 3, 2018
Presentation Time: 6:00 PM - 8:00 PM PST
Location: San Diego Convention Center, Hall GH
Abstract #3766
Prediction of Response to Fostamatinib based on the Presence of Plasma Platelet Autoantibodies in Adult Patients with Immune Thrombocytopenia (ITP) – Exploratory Analyses from Phase 3 Studies
Session Name: 311. Disorders of Platelet Number or Function: Poster III
Date: Monday, December 3, 2018
Presentation Time: 6:00 PM - 8:00 PM PST
Location: San Diego Convention Center, Hall GH
The conference abstracts can be accessed here.
To learn more about Rigel Pharmaceuticals and TAVALISSE™ visit booth #1449 during ASH 2018.
About ITP
In patients with ITP, the immune system attacks and destroys the body's own blood platelets, which play an active role in blood clotting and healing. Common symptoms of ITP are excessive bruising and bleeding. People suffering with chronic ITP may live with an increased risk of severe bleeding events that can result in serious medical complications or even death. Current therapies for ITP include steroids, blood platelet production boosters (TPOs) and splenectomy. However, not all patients respond to existing therapies. As a result, there remains a significant medical need for additional treatment options for patients with ITP.
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 TAVALISSE
Indication
TAVALISSE™ (fostamatinib disodium hexahydrate) tablets is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.
Important Safety Information
Warnings and Precautions
Drug Interactions
Adverse Reactions
Please see www.TAVALISSE.com for full Prescribing Information.
To report side effects of prescription drugs to the FDA, visit www.fda.gov/medwatch or call 1-800-FDA-1088 (800-332-1088).
TAVALISSE is a trademark of Rigel Pharmaceuticals, Inc.
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 clinical programs include an upcoming Phase 3 study of fostamatinib1 in autoimmune hemolytic anemia and an ongoing Phase 1 study of R8351, a proprietary molecule from its interleukin receptor associated kinase (IRAK) program. In addition, Rigel has product candidates in development with partners BerGenBio AS, Daiichi Sankyo, and Aclaris Therapeutics.
1 The product for this use or indication is investigational and has not been proven safe or effective by any regulatory authority.
Contact: David Burke
Phone: 650.624.1232
Email: dburke@rigel.com
Media Contact: Jessica Daitch
Phone: 917.816.6712
Email: jessica.daitch@syneoshealth.com
SOURCE Rigel Pharmaceuticals, Inc.