Tiziana Enrolls Second Patient in Ongoing Intranasal Foralumab Evaluation for Secondary Progressive Multiple Sclerosis
- Clinical data from the first patient, after completing 3 out of 6 months, suggest that the treatment was well tolerated with a favorable clinical response
- FDA allows for continued enrollment under the Individual Patient Expanded Access Program
NEW YORK, Jan. 10, 2022 (GLOBE NEWSWIRE) -- Tiziana Life Sciences (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company enabling breakthrough immunotherapies via novel routes of drug delivery, is pleased to announce that the U.S. Food and Drug Administration (FDA) allowed enrollment of a second patient in the ongoing clinical treatment of secondary progressive multiple sclerosis (SPMS) with intranasally administered foralumab, a fully human anti-CD3 monoclonal antibody, at the Brigham and Women’s Hospital (BWH), Harvard University, Boston, MA.
Dr. Kunwar Shailubhai, Chief Executive Officer of Tiziana noted, “We have been systematically building a database of evidence to support both the safety and clinical potential of intranasal and oral forms of foralumab in close collaboration with the FDA, and during 2022 plan to initiate several new trials across areas of large unmet need, including MS, Crohn’s Disease, and Type 1 Diabetes. Today’s update marks important progress in the advancement of our MS program, and supports our novel approach to provide local, rather than systemic delivery of antibodies.”
The first patient treated under this program completed 3 out of 6 months of dosing. Interim data suggest that the treatment was well-tolerated with a favorable clinical response. As part of the regulatory process, three-month safety data were submitted to the FDA, seeking permission to treat an additional patient under an Individual Patient Expanded Access Investigational New Drug Application (IND), which has been allowed. Treatment of the second patient is expected to begin during January 2022 with interim clinical data after 3 out of 6 months of treatment expected in April 2022. The treatment plan will remain unchanged as per the original IND. The Investigators at BWH will be monitoring detailed safety, neurological, and Positron Emission Tomography (PET) to evaluate microglial activation in this patient. Modification of immunological and neurodegenerative markers will also be included as part of the standard investigation to be conducted by BWH.
The ongoing treatment of the first patient continues, and six months of dosing is expected to be completed by the end of March 2022. To date, this patient has not shown signs of treatment intolerance or toxicities and appears to be responding well to treatment. The brain imaging data, as analyzed by PET, show reduction in microglial cell activation. Published PET studies have shown an increase in activated microglial cells in patients with SPMS, and that their increased presence in the brain is associated with higher scores on the Expanded Disability Status Scale (EDSS), a scale that is widely usd to assess cognitive disability1. Consistent with these findings, Tysabri® (natalizumab) (NASDAQ: BIIB), an approved drug for treatment of MS, is also believed to act via reduction in microglial activation.
Howard Weiner, M.D., Director of the Multiple Sclerosis Program at BWH and Chairman of Tiziana’s Scientific Advisory Board, commented, “The potential for intranasally administered foralumab to suppress microglial activation is a promising and novel approach to provide a potentially safe treatment of SPMS that currently has no effective treatment. We are extremely pleased with the tolerability of the treatment seen to date as well as with the positive clinical responses observed after completion of three months of dosing in the first patient, and we look forward to clinical data after completion of six months of treatment.”
Tanuja Chitnis, M.D., Principal Investigator and Professor of Neurology at Harvard Medical School and senior neurologist at BWH and Massachusetts General Hospital added, “New treatments for progressive MS are urgently needed. Intranasal foralumab could revolutionize treatment for this disabling form of disease.”
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, oral and inhalation approaches in development have the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous (IV) delivery. Tiziana’s two lead candidates, intranasal foralumab, the only fully human anti-CD3 mAb, and milciclib, a pan-CDK inhibitor, have both 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 further enquiries:
1. Politis M, et al., Increased PK11195 PET binding in the cortex of patients with MS correlates with disability. Neurology. 2012; 79(6): 523-30
IDEA SHOWCASE RECEPTION AND PITCH EVENT - Open to all Badge Holders
Solutions Showcase - Battle for the ROI
Digital Innovation & Transformation Legal Trends