Full Press Release Details
Life Sciences Announces Near- Term Strategic Focus on Intranasal Foralumab for Diseases of the Central Nervous System (CNS)
conference call via webcast at 10 am ET -
NEW YORK, November 10, 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 a corporate update, including its near-term focus on developing intranasal
foralumab for inflammatory diseases of the Central Nervous System (CNS) such as non-active secondary-progressive Multiple Sclerosis (SPMS),
Alzheimer's disease and amyotrophic lateral sclerosis (ALS).
Gabriele Cerrone, Executive Chairman and interim Chief Executive Officer
of Tiziana, remarked, "We look forward to leveraging the exciting clinical and preclinical results from our very promising formulation
of intranasal foralumab that we have generated so far in CNS-based autoimmune diseases to guide our pipeline investment. Our near-term
strategic focus to prioritize resources for the clinical development of this unique therapeutic candidate will allow Tiziana to focus
on areas of greatest potential success, be highly efficient in our development timelines and maximize shareholder value while still maintaining
optionality for our other research programs, including milciclib in oncology. We aim to become a leading company pioneering intranasal
therapies for CNS-based diseases and have sufficient capital to fund our programs until the first quarter of 2024."
To date, Tiziana's fully human anti-CD3 monoclonal antibody,
foralumab, administered intranasally through Tiziana's proprietary drug delivery technology, has shown benefit in several different
pre-clinical models of CNS-based inflammatory disease. These studies confirmed the uptake of the drug in the cervical lymph nodes of these
animal models - an area rich in lymphocytes that is a key site of action to target since it then spurs the production of T-cells
and reduces inflammation.
Matthew W. Davis, M.D., RPh, Chief Medical Officer of Tiziana, added,
"Tiziana along with our academic partners collectively believe that many inflammatory CNS disease pathologies could benefit from
intranasally administered foralumab and, as such, are focusing our efforts in this area due to the positive clinical and pre-clinical
findings we've seen to date across several CNS inflammatory diseases. We embark on this journey with our partners at Brigham and
Women's Hospital and look forward to studying intranasal foralumab to address a range of underserved inflammatory CNS conditions."
Tiziana expects to announce the result of
the six-month PET scan on patient EA2 and the nine-month PET scan on patient EA1 also in the first quarter of 2023. Additionally, Tiziana
recently announced the completion of enrollment for the first cohort of its intermediate-size patient population (four patients) to continue
to evaluate the safety and activity of intranasal foralumab in non-active SPMS patients, as part of its Expanded Access Program (EAP).
During the first quarter of 2023, the Company then plans to perform three-month PET scans on patients EA3 through EA6 anticipating the
results to be available in Q2 2023.
Separately, in the fourth quarter of 2022,
Tiziana expects to request a "Type C" meeting with FDA to discuss its Phase 2 program for evaluating foralumab in non-active
SPMS patients and receive feedback from FDA by the end of the first quarter of 2023.
Conference Call Webcast Information
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About Tiziana Life Sciences
Tiziana Life Sciences is a clinical-stage
biopharmaceutical company developing breakthrough immunomodulation therapies using transformational drug delivery technologies with a
focus on its lead candidate, intranasal foralumab, as a treatment for diseases of the central nervous system (CNS). 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 intranasal foralumab is the only fully human anti-CD3 mAb and has 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
Source: Tiziana Life Sciences Ltd.