Tiziana Life Sciences has announced that a second multiple sclerosis patient who received the company’s intranasal foralumab for three months as part of an expanded access program at Brigham and Women’s Hospital (BWH) has showed significant improvement. According to Tiziana, PET imaging demonstrated inhibition of microglial activation, and the patient also showed improvement in a timed 25-foot walk test and a neurologic examination.
In March 2022, the company reported that six months of treatment with the nasal formulation inhibited microglial cell activation throughout the brain of a patient with secondary progressive multiple sclerosis (SPMS) at BWH. The next month, Tiziana said that the FDA would allow the company to treat an additional eight patients with secondary progressive multiple sclerosis (SPMS) under its Intermediate-Size Patient Population Expanded Access IND. The first two patients are also continuing intranasal foralumab therapy, the company said, with the first patient now in the 13th month of treatment.
BWH Director of PET Imaging Program in Neurologic Diseases Tarun Singhal said, “Our current analyses suggest a consistency of response to intranasal foralumab, across the first two SPMS patients. We were also able to harmonize data across scanners and institutions, which has yielded very encouraging results. We look forward to our continued investigations of foralumab in SPMS patients, using additional PET analytical approaches.”
Howard Weiner, Director of BWH’s Multiple Sclerosis Program and chair of the Tiziana scientific advisory board, added, “We are very pleased by both the biological and clinical improvement observed in the second patient after treatment with intranasal foralumab for three months, which provides confirmation that the intranasal dosing modulates the systemic immune response and in turn dampens brain inflammation. It is encouraging to see the consistency of response between the first and second patient and that the treatment was well tolerated.”
Tiziana Life Sciences CEO and Chief Scientific Officer Kunwar Shailubhai said, “We are excited about the positive clinical responses seen in two out of two SPMS patients treated so far. Clinical data from both patients further validate our novel intranasal therapy with foralumab, which seems to overcome the blood-brain barrier to allow therapeutic action of the drug.”
Read the Tiziana Life Sciences press release.
