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Cytocom Inc. (NASDAQ:CBLI), a leading biopharmaceutical company creating next-generation immune therapies that focus on immune restoration and homeostasis, today provided an update regarding its portfolio of clinical programs.
"We are excited and believe that we are well positioned to further the development of our clinical-stage pipeline and showcase the power of our expanded post-merger drug development capabilities," stated Michael K. Handley, President and CEO of Cytocom. "We are strategically focused on immune-modulating treatments designed to address anemia and neutropenia, emergent viruses, cancer, and autoimmune diseases."
Mr. Handley continued, "The coming months will be busy. We are completing the necessary steps to begin enrolling patients by year-end 2021 in a Phase 3 clinical trial for our lead drug candidate, CYTO-201, for the treatment of Crohn's disease. Building on our legacy Cytocom pipeline are the Cleveland BioLabs assets, specifically entolimod, an immune-stimulatory agent. We are eager to explore new indications for entolimod and remain excited about the potential for toll-like receptor 5 agonists in treating neutropenia and anemia in cancer patients. Our team is working to put together development plans in hematology and we are in talks with a renowned medical facility to begin a clinical study using entolimod in the coming months."
Mr. Handley concluded, "In addition, we plan to follow in the first half of 2022 with a clinical trial exploring CYTO-401 as an adjunct to standard of care therapy to extend the duration of disease remission in patients with pancreatic cancer. We are also completing the necessary steps to activate clinical trial sites and begin enrolling patients in clinical trials exploring CYTO-205 in patients with acute and post-acute COVID-19. This could be a particularly compelling opportunity given the pernicious nature of the SARS-CoV-2 virus, which, despite growing vaccination rates, continues to impact millions of people worldwide. What's more, the medical community has specifically expressed interest on a "long haulers" study."
CYTO-201 and Crohn's Disease
Cytocom's lead investigational drug candidate, CYTO-201, is being studied for the treatment of pediatric patients with Crohn's disease, an inflammatory bowel disease that causes chronic inflammation of the gastrointestinal (or digestive) tract, causing symptoms such as persistent diarrhea, abdominal pain and rectal bleeding. Studies show that because the signs and symptoms of the disease are unpredictable, patients living with the disease endure significant burdens, not only physical, but also emotional and economic.
On July 27, 2021, Cytocom completed a successful end of Phase 2 meeting with the U.S. Food and Drug Administration (FDA) regarding a clinical development plan for a Phase 3 clinical trial evaluating CYTO-201 in pediatric Crohn's patients. Cytocom is partnering with ICON plc, a global contract research organization (CRO), to manage the trial, and expects to begin enrolling patients by year-end 2021.
Posted In: CBLI
