Statera Biopharma Inc. (NASDAQ: STAB) has announced that the US FDA has lifted the clinical hold on its Entolimod R&D activity in acute radiation syndrome. Based on Statera’s response, the agency acknowledged that the company had addressed past regulatory matters.
FDA’s clinical hold on Enolimod study lifted
We are pleased that the FDA’s clinical hold questions have been successfully addressed, allowing us to continue our clinical work in ARS and explore new indications for Entolimod in hematology, specifically the treatment of neutropenia and anemia in cancer patients. We look forward to accelerating the development of Entolimod as part of our mission to introduce a new generation of immunotherapies targeting serious medical needs,” stated the company’s CEO and President Michael Handley.
Statera wants to examine ongoing development needs and medical requirements for Entolimod based on results demonstrating safety and efficacy in acute radiation syndrome.
Furthermore, Statera is launching an oncology and hematology development program based on the promise that toll-like receptor five agonists like Entolimod have demonstrated in the treatment of anemia and neutropenia in cancer patients. Talks are underway with a prestigious American academic institution to begin the first research of Entolimod in this new research area next year.
Statera offers a range of toll-like receptor agonists.
The company is developing proprietary immunotherapies that target anemia/neutropenia, autoimmune cancers, and emerging cancers through a novel platform meant to restore homeostasis and rebalance the body’s immune system. With TLR4 and TLR9 antagonists and TLR5 agonists Entolimod and GP532, Statera offers one of the broadest platforms of toll-like receptor (TLR) agonists in the biopharmaceutical sector. TLRs are a protein family that plays an important function in the body’s immune system.
Also, the company is working on medicines that will directly elicit a powerful and long-lasting response of antigen-specific killer T-cells and antibodies in patients, thereby triggering critical immune defenses against autoimmune, inflammatory, viral, and cancer disorders. In addition to expanding into fibromyalgia and multiple sclerosis, Statera has clinical studies for Crohn’s disease (STAT-201), pancreatic cancer (STAT-401), hematological (Entolimod), and COVID-19 (STAT-205).
