Tiziana Life Sciences Ltd (NASDAQ:TLSA) has reported further positive results from a patient with non-active secondary progressive multiple sclerosis (SPMS) being treated with the company’s intranasal foralumab (formerly NI-0401).
After receiving intranasal foralumab treatment for six months, the second patient (EA2) with SPMS has shown additional clinical improvements as measured by the Expanded Disability Status Scale (EDSS), a standard clinical assessment, the company said.
"Coupled with our PET imaging data demonstrating inhibition of microglial activation, I am truly excited and encouraged by the clinical benefits shown so far for the first two expanded access patients receiving intranasal foralumab for SPMS," commented Gabriele Cerrone, executive chairman and interim chief executive officer of Tiziana in a statement.
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On September 12, 2022, the second patient had walked 100 meters without a cane or need for rest. Prior to this, on June 8, 2022, the patient required a cane to walk 100 meters.
This corresponds with a clinically meaningful improvement in the EDSS score of 0.5. The patient's pyramidal score remained stable and did not worsen over time. The patient has received a total of 10.5 treatment cycles of foralumab to date, Tiziana noted.
"I am pleased, but not surprised to see additional clinical improvement in the second patient. SPMS represents an advanced stage of multiple sclerosis with few treatment options and creates a severe burden on patients," said Dr Howard L Weiner, co-director of the Ann Romney Center for Neurologic Diseases at Brigham and Women's Hospital (BWH) and chairman of Tiziana's Scientific Advisory Board.
Dr Tanuja Chitnis, professor of neurology and the principal investigator of the clinical study at BWH, noted that patients with non-active SPMS normally do not improve over a six-month time course.
“I am very encouraged by these results and look forward to seeing this patient's PET imaging to determine if there is a continued reduction in microglial activation to correlate with the improvement we are observing in the patient's clinical exam," she said.
Cerrone said the program is “a top priority” for Tiziana, adding that the company expects to enroll four additional patients with SPMS at BWH in the fourth quarter of 2022.
Foralumab, the only entirely human anti-CD3 mAb, has shown reduced release of cytokines after IV administration in healthy volunteers and in patients with Crohn's disease.
In a humanized mouse model (NOD/SCID IL2gammac-/-), it was shown that while targeting the T-cell receptor, orally administered foralumab modulates immune responses of the T-cells and enhances regulatory T-cells (Tregs), thereby providing therapeutic benefit in treating inflammatory and autoimmune diseases without the occurrence of potential adverse events usually associated with parenteral mAb therapy.
Once-a-day treatment for 10 consecutive days with intranasal foralumab was both well tolerated and produced clinical responses in COVID-19 patients. Based on these studies, the intranasal and oral administration of Foralumab offers the potential to become a well-tolerated immunotherapy for autoimmune and inflammatory diseases by the induction of Tregs.
Tiziana Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy.
Contact the author at jon.hopkins@proactiveinvestors.com