Tiziana Life Sciences Ltd announced that the US Food and Drugs Administration (FDA) has accepted its request to enroll a second patient onto the ongoing clinical treatment of secondary progressive multiple sclerosis (SPMS).
Tiziana, a biotechnology company that enables immunotherapies via novel routes of drug delivery, is evaluating nasally administered foralumab for SPMS.
Clinical data from the first patient, having completed three of six months, revealed the treatment was well tolerated by the patient with a favourable clinical response.
“This patient has not shown signs of treatment intolerance or toxicities and appears to be responding well to treatment, [while] the brain imaging data is showing a reduction in microglial cell activation,” said chief executive Dr Kunwar Shailubhai.
The FDA has allowed continued enrolment under the Individual Patient Expanded Access Programme.
Treatment for this second patient with the foralumab, a fully human anti-CD3 monoclonal antibody, is expected to begin this month, with clinical data after three months available from April, it said.
"New treatments for progressive MS are urgently needed, [so] intranasal foralumab could revolutionise treatment for this disabling form of disease," said Tanuja Chitnis, doctor of medicine (MD), and principal investigator of Neurology at Harvard Medical.
Shailubhai said Tiziana intends to initiate several new trials across areas of large unmet need in 2022, including MS, Crohn's Disease, and Type One diabetes.