Tiziana Life Sciences PLC (NASDAQ:TLSA) said the US Food and Drug Administration (FDA) has given permission for the enrollment of additional Secondary Progressive Multiple Sclerosis (SPMS) patients for treatment with intranasal foralumab.
The company said its collaborators at the Brigham and Women's Hospital (BWH) Boston MA have received a 'Study May Proceed Letter' from the FDA to initiate treatment in up to an additional eight SPMS patients as part of an Intermediate-Size Patient Population Expanded Access Investigational New Drug (IND).
Safety, tolerability, and clinical responses from the first two SPMS patients were submitted to the regulator to seek permission to treat up to a further eight SPMS patients with the goal of obtaining more clinical data to assess robustness of the clinical responses.
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The foralumab dose will remain at 50 micrograms (mcg) three times a week (MWF), which is the same dose administered previously to the first two SPMS patients. The dosing regimen in this IND also has a provision for dose escalation up to 100 mcg three times a week (MWF) as an option to improve clinical benefit, if needed, Tiziana noted.
"Treatment with intranasal foralumab is a novel physiological approach to stimulate the mucosal immune system to induce disease-modifying benefits in the CNS [central nervous system] by dampening microglial inflammation,” said Howard Weiner, M.D., Director of the Multiple Sclerosis Program at the BWH and chairman of Tiziana's Scientific Advisory Board.
“The first validation of our innovative approach came from our recently reported results showing positive clinical benefits and microglial modulation in a patient with secondary progressive multiple sclerosis who was treated for six months with nasal Foralumab3. This now opens the door to treat other neurologic diseases which have microglial inflammation - such as Alzheimer's disease - with intranasal foralumab. "
The treatment plan will be submitted to the Institutional Review Board (IRB) of BWH prior to initiation of patient enrollment and initiation of the study, which is anticipated to be in July this year.
While the primary objectives are safety, tolerability and patient benefits, additional measures will assess clinical and immune responses, including imaging by positron emission tomography (PET), specifically to assess inhibition of microglial activation, Tiziana explained.
Dr Tanuja Chitnis, M.D., professor at the BWH and a member of Tiziana's Scientific Advisory Board said: "Therapies to slow progression in multiple sclerosis are much needed. We are grateful to have the opportunity to offer intranasal foralumab to progressive MS patients."
Tiziana Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy. The company'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.
The company's technology for alternative routes of immunotherapy has been patented with several applications pending and is expected to allow for broad pipeline applications.
Contact the author at jon.hopkins@proactiveinvestors.com