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Hemogenyx Pharmaceuticals PLC Announces FDA Annual Report
Hemogenyx Pharmaceuticals Files Annual IND Report with FDA for HG-CT-1 CAR-T Therapy for AML LONDON, UK / ACCESS Newswire / April 3, 2025 /Hemogenyx Pharmaceuticals plc (LSE:HEMO) is pleased to announce that it has submitted its Annual Report to the ...
About this update from Hemogenyx Pharmaceuticals Plc
[{"type":"text","content":"Hemogenyx Pharmaceuticals Files Annual IND Report with FDA for HG-CT-1 CAR-T Therapy for AML","length":92,"tagName":"p"},{"type":"text","content":"LONDON, UK / ACCESS Newswire / April 3, 2025 / Hemogenyx Pharmaceuticals plc (LSE:HEMO) is pleased to announce that it has submitted its Annual Report to the U.S. Food and Drug Administration (FDA) under the active Investigational New Drug (IND) application for HG-CT-1, the Company's proprietary CAR-T cell therapy for the treatment of relapsed or refractory acute myeloid leukemia (R/R AML).","length":397,"tagName":"p"},{"type":"text","content":"The annual report provides a comprehensive update on the Company's activities under the IND during the first year of the clinical trial of HG-CT-1 and includes the following key elements:","length":191,"tagName":"p"},{"type":"text","content":"1. Individual Study Information:","length":32,"tagName":"p"},{"type":"text","content":"A summary of the ongoing clinical study, including its title, design, purpose and objectives, patient population, the total number of planned subjects, and the number enrolled as of the IND anniversary date (February 6, 2025). The report confirms the enrollment of the first patient and includes demographic details such as age, sex, and race.","length":343,"tagName":"p"},{"type":"text","content":"2. Quality Summary Information:","length":31,"tagName":"p"},{"type":"text","content":"Data obtained from the past year's investigations under the IND related to the stability of the HG-CT-1 drug product and the lentiviral vector used in its manufacturing.","length":173,"tagName":"p"},{"type":"text","content":"3. Update to the General Investigational Plan:","length":46,"tagName":"p"},{"type":"text","content":"A forward-looking update outlining the plan for continued patient enrollment during the upcoming year of the study.","length":115,"tagName":"p"},{"type":"text","content":"This filing marks another important step in the Company's clinical development of HG-CT-1 and reaffirms its commitment to regulatory compliance and transparent communication with stakeholders.","length":196,"tagName":"p"},{"type":"text","content":"Further updates will be provided as the trial progresses.","length":57,"tagName":"p"},{"type":"text","content":"Dr. Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals, commented:&q...