Patient Enrollment Resumed in the Investigator-initiated Phase 1/2 Clinical Trial of Seclidemstat in Combination with Azacitidine to Treat Hematologic Cancers Company Implemented Significant...
HOUSTON, Jan. 03, 2024 (GLOBE NEWSWIRE) -- Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX) announces that the hematologic cancer Phase 1/2 clinical trial being conducted at the University of Texas MD...
HONG KONG, Dec. 15, 2023 /PRNewswire/ -- Akeso published two phase Ib clinical results of its innovative CD47 monoclonal antibody ligufalimab (AK117) in combination with azacitidine in patients with newly diagnosed higher-risk myelodysplastic syndrome (HR-MDS) and treatment-naïve acute myeloid leukemia (AML) at the 65th American Society of Hematology (ASH) Annual Meeting.
“ Observed 79% Objective Response Rate (ORR) in frontline HR-MDS patients, primarily with TP53 mutations; initial complete response (CR)/marrow complete response (mCR) rate of 64% “ “ Observed 27%...
ImmunoGen Presents Findings from Phase 1b/2 Study of Pivekimab Sunirine at ASH
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Syros Pharmaceuticals (NASDAQ: SYRS), a biopharmaceutical company committed to advancing new standards of care for the frontline treatment of hematologic malignancies, today announced strong and encouraging initial data from its ongoing SELECT-AML-1 Phase 2 trial evaluating tamibarotene, an oral, selective, retinoic acid receptor alpha (RAR?) agonist, in combination with venetoclax and azacitidine in newly diagnosed, unfit patients with acute myeloid leukemia (AML) and RARA gene overexpression.
HONG KONG, Sept. 27, 2023 /PRNewswire/ -- Akeso, Inc. (the Company, Akeso, 9926.HK) announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application for AK117, a next generation CD47 monoclonal antibody in combination with azacitidine for treatment of patients with newly diagnosed higher-risk myelodysplastic syndromes (MDS). The upcoming study, known as a randomized, double-blind, global multi-center Phase II study, is set to be conducted in the United States.
FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Phase 3 ENHANCE study in higher-risk myelodysplastic syndromes (MDS) has been discontinued due to futility based on a planned analysis. The safety data seen in this study is consistent with the known magrolimab profile and adverse events that are typical in this patient population. Gilead recommends discontinuing treatment with magrolimab in patients with MDS. Magrolimab is a potential first-in-class, anti-CD47 immunotherapy with a clinical development program spanning ten potential indications including ongoing trials in solid tumors and two pivotal trials: ENHANCE-2 study in acute myeloid leukemia (AML) with TP53 mutations and ENHANCE-3 in first-line, unfit AML.
Intas Pharmaceuticals Limited on FDA Import Alert List
TOKUSHIMA, Japan--(BUSINESS WIRE)--150 patients have been enrolled at the multi-clinical centers in US to the Phase 3 randomized trial of DFP-10917 vs non-intensive reinduction (LoDAC, Azacytidine, Decitabine, Venetoclax combo-regimens) or intensive reinduction (high and intermediate dose of Cytarabine regimens) in the 2nd, 3rd, or 4th salvage of AML and the 1st interim analysis of this study shall be done for NDA approval to the FDA in US soon after confirmation of the superiority of DFP-10917 arm. The endpoint is CR rate for primary and the Overall Survival for secondary. DFP-10917 (Radgocitabine) was granted as Orphan Drug Designation (ODD) by the FDA in US.