FDA Approves Hemogenyx's Phase I HEMO-CAR-T Trials

Hemogenyx Pharmaceuticals, a London-based biopharmaceutical firm listed on the London Stock Exchange (LSE:HEMO), has received approval from the U.S. Food and Drug Administration (FDA) to commence Phase I clinical trials for its innovative HEMO-CAR-T treatment for acute myeloid leukemia (AML). The FDA has confirmed that all concerns previously raised have been adequately addressed by the company, thus granting permission to proceed with the clinical study.
Dr. Vladislav Sandler, CEO and Co-Founder of Hemogenyx Pharmaceuticals, expressed enthusiasm over the FDA's decision and emphasized the company's commitment to advancing HEMO-CAR-T's clinical development to provide a potentially life-saving option for patients. He credited the company's team and advisors for their dedication and hard work in achieving this milestone.
AML is the most prevalent form of acute leukemia in adults, characterized by low survival rates, with less than 30% of adults surviving five years post-diagnosis. Traditionally, AML has been treated with chemotherapy; however, Hemogenyx is pioneering a new treatment approach that may offer a more effective and less harmful alternative.
CAR-T therapy, the focus of Hemogenyx's research, is a cutting-edge treatment method that involves genetically modifying a patient's T-cells to target and destroy cancer cells. The process includes extracting T-cells from the patient, modifying them in a lab with a CAR gene construct, multiplying the modified T-cells, and then infusing them back into the patient.
The announcement also included a disclosure under the Market Abuse Regulation (MAR), indicating that specific information within the announcement was considered inside information under Article 7 of Regulation No 596/2014 until its release. Dr. Sandler is identified as the responsible person for the announcement's release.
Hemogenyx Pharmaceuticals operates from its headquarters in London and has U.S. subsidiaries, Hemogenyx Pharmaceuticals LLC and Immugenyx LLC, based in New York City. The company is in the pre-clinical stage, developing novel treatments for blood and autoimmune diseases, aiming to expand the reach of bone marrow transplantation for patients with life-threatening diseases. Hemogenyx is also working on several product candidates and a platform technology to drive new product development.
The company's information is disseminated through RNS, the news service of the London Stock Exchange, which is authorized by the Financial Conduct Authority as a Primary Information Provider in the UK. 

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