TIZIANA LIFE SCIENCES LTD Tiziana Life Sciences announced 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. 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 used to assess cognitive disability1.
Consistent with these findings, Tysabri® (natalizumab), an approved drug for treatment of MS, is also believed to act via reduction in microglial activation.
