Full Press Release Details
Life Sciences Announces Continued Clinical Improvements in the Second Patient with Secondary Progressive Multiple Sclerosis (SPMS) After
Six Months of Dosing with Intranasal Foralumab
NEW YORK, Sept. 20, 2022 - Tiziana
Life Sciences Ltd. (Nasdaq: TLSA) ("Tiziana" or the "Company"), a biotechnology company developing breakthrough
immunomodulation therapies via novel routes of drug delivery, today announced that the second patient ("EA2") with non-active
secondary progressive multiple sclerosis (SPMS) receiving intranasal foralumab has shown additional clinical improvements as measured
by the Expanded Disability Status Scale (EDSS), a standard clinical assessment.
On September 12th, 2022, this 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. This patient has received a total of 10.5 treatment cycles of foralumab to date.
"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. "This program is a top priority for us, and we expect to enroll four additional patients with
SPMS at Brigham and Women's Hospital (BWH) in Q4 2022."
Howard L. Weiner, M.D., Co-Director of the Ann
Romney Center for Neurologic Diseases at BWH and Chairman of Tiziana's Scientific Advisory Board, stated, "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."
Chitnis, M.D., Professor of Neurology and the Principal investigator of the clinical study at
BWH said, "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."
Foralumab (formerly NI-0401), 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 IL2 c-/-), 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.
About Tiziana Life Sciences
Tiziana Life Sciences is a clinical-stage
biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes
of immunotherapy. Tiziana'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. Tiziana's technology for alternative routes of immunotherapy has been patented
with several applications pending and is expected to allow for broad pipeline applications.
For further inquiries:
Tiziana Life Sciences Ltd
Hana Malik, Business Development and Investor
+44 (0) 207 495 2379
email: info@tizianalifesciences.com
LifeSci Advisors, LLC