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Rigel Announces Collaboration with CONNECT to Conduct a Phase 2 Trial of Olutasidenib in Glioma
SOUTH SAN FRANCISCO, Calif., Jan. 4, 2024 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced a collaboration with CONNECT, an
About this update from Rigel Pharmaceuticals, Inc.
[{"type":"text","content":"SOUTH SAN FRANCISCO, Calif., Jan. 4, 2024 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced a collaboration with CONNECT, an international collaborative network of pediatric cancer centers, to conduct a Phase 2 clinical trial to evaluate REZLIDHIA® (olutasidenib) in combination with temozolomide as maintenance therapy in newly diagnosed pediatric and young adult patients with high-grade glioma (HGG) harboring an isocitrate dehydrogenase-1 (IDH1) mutation.\nUnder the collaboration, CONNECT will include olutasidenib in CONNECT's TarGeT-D, a molecularly guided Phase 2 umbrella clinical trial for HGG. The Rigel-sponsored arm will study post-radiotherapy administration of olutasidenib in combination with temozolomide followed by olutasidenib monotherapy as maintenance treatment in newly diagnosed pediatric and young adult patients (less than 39 years old) with IDH1 mutation positive HGG, including diffuse intrinsic pontine glioma (DIPG), an aggressive brain tumor with limited treatment options. Rigel will provide funding up to $3 million and study material over the four-year collaboration.\n\"We are excited to collaborate with CONNECT to evaluate olutasidenib in high grade glioma,\" said Raul Rodriguez, Rigel's president and CEO. \"We believe olutasidenib has potential in a variety of cancers where mIDH1 plays an important role and we look forward to generating new data in this disease state, which has a high unmet need. This collaboration builds on our hematology-oncology pipeline expansion strategy and enables us to explore the potential of olutasidenib in a focused and efficient manner.\"\nThis open label Phase 2 trial will be overseen by Drs. Santosh Valvi and Nicholas Gottardo, Perth Children's Hospital, Dr. Michael J Fisher, Children's Hospital of Philadelphia, and Dr. Maryam Fouladi, Nationwide Children's Hospital, and aims to enroll approximately 60 patients. The primary objective of the olutasidenib arm of the trial is to estimate progression-free survival. The study will also characterize the safety, tolerability, and pharmacokinetics of olutasidenib in pediatric and young adult patients. The study is estimated to begin enrolling patients in the first half of 2024 and will fulfill Rigel's post-marketing pediatric study requirement related to the FDA approval of REZLIDHIA in relapsed or refractory (R...