Tiziana Receives FDA Expanded Access in Alzheimer’s Disease Study
Biotechnology company, Tiziana Life Sciences (Nasdaq: TLSA) has received approval from the FDA for an Expanded Access (EA) Investigational New Drug (IND) for its intranasal foralumab candidate. Tiziana is evaluating intranasal foralumab as a treatment for moderate Alzheimer’s disease. The company expects to treat the first patient in its study next month.
Tiziana believes that foralumab could be a potentially groundbreaking treatment for Alzheimer’s disease. The drug targets the disease’s underlying pathology by addressing the resulting neuroinflammation caused by the accumulation of toxic proteins in the brain.
Commenting on the trial, Principal Investigator, Howard L. Weiner, M.D., Chairman of Tiziana’s Scientific Advisory Board and co-director of the Ann Romney Center for Neurologic Diseases at Brigham and Women’s Hospital, a founding member of Mass General Brigham healthcare system, said, “Given that nasal foralumab dampens microglial inflammation in subjects with advanced progressive MS and microglial activation is a prominent feature of Alzheimer’s disease, Tiziana is hopeful that nasal foralumab will help slow the progression of cognitive decline in this first patient.
“We will work closely with FDA to evaluate the treatment responses in this patient with moderate AD, while we initiate our Phase 2 study Alzheimer’s Disease in patients with early symptomatic disease.”
Expanded access INDs provide a pathway for patients to gain access to investigational drugs, biologics, and medical devices used to diagnose, monitor, or treat patients with serious diseases or conditions for which there are no comparable or satisfactory therapy options available outside of clinical trials.
About Tiziana Life Sciences
Tiziana Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy. Tiziana’s innovative nasal approach has the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous (IV) delivery. Tiziana’s lead candidate, intranasal foralumab, which is the only fully human anti-CD3 mAb, has demonstrated a favorable safety profile and clinical response in patients in studies to date. Tiziana’s technology for alternative routes of immunotherapy has been patented with several applications pending and is expected to allow for broad pipeline applications. For more information please visit our website: www.tizianalifesciences.com
