Full Press Release Details
Life Sciences Announces FDA IND Clearance of Intranasal Foralumab for the Treatment of Alzheimer's Disease
NEW YORK, August 15, 2023 -- 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 U.S. Food and Drug Administration (FDA) has cleared the Investigational New
Drug (IND) application for intranasal foralumab to be studied in Alzheimer's disease. Foralumab could be a potentially groundbreaking
treatment for Alzheimer's disease, given it targets the disease's underlying pathology by addressing the resulting neuroinflammation
caused by the accumulation of toxic proteins in the brain.
Gabriele Cerrone, Chairman, acting CEO and founder of Tiziana Life
Sciences, stated, "The IND clearance is a significant milestone for Tiziana that highlights the strength and the therapeutic potential
of foralumab. We are deeply committed to advancing the field of neurodegenerative diseases and bringing much-needed relief to patients
suffering from Alzheimer's with a novel therapeutic approach. We are thrilled to have reached this critical juncture and are eager to
move forward with the necessary trials to evaluate the effectiveness of foralumab in Alzheimer's disease in combination with an
FDA approved therapy or as a single agent."
Professor Howard L. Weiner, the Robert L. Kroc Professor of Neurology
at the Harvard Medical School, Director and Founder of the Partners Multiple Sclerosis Center and Co-Director of the Center for Neurologic
Diseases at Brigham and Women's Hospital, a founding member of Mass General Brigham Healthcare System, added "The IND clearance
is a significant step forward in the fight against Alzheimer's disease. Foralumab shows great promise in targeting the pathological hallmarks
of the disease, and I am optimistic about its potential to offer a breakthrough treatment option for patients suffering from this devastating
condition. I look forward to witnessing the progress of this important therapy."
Activated T cells play an important role
in the inflammatory process. Foralumab, the only fully human anti-CD3 monoclonal antibody (mAb), binds to the T cell receptor and dampens
inflammation by modulating T cell function, thereby suppressing effector features in multiple immune cell subsets. This effect has been
demonstrated in patients with COVID and with multiple sclerosis, as well as in healthy normal subjects. Intranasal foralumab Phase 2 trials
are expected to start in the third quarter of 2023 in patients with non-active SPMS. Immunomodulation by nasal anti-CD3 mAb represents
a novel avenue for treatment of inflammatory human diseases.1
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 approach has the potential to provide an improvement in efficacy as well as safety
and tolerability compared to intravenous (IV) delivery. Tiziana's lead candidate, intranasal foralumab, which is the only fully
human anti-CD3 mAb, 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.
Forward-Looking Statements
Certain statements made in this announcement
are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company's current
expectations, estimates, and projections about its industry; its beliefs; and assumptions. Words such as anticipates,' expects,' intends,'
plans,' believes,' seeks,' estimates,' and similar expressions are intended to identify forward-looking statements. These statements
are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are
beyond the Company's control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted
in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance
on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking
statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake
any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated
events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.
For further inquiries:
Tiziana Life Sciences Ltd
Paul Spencer, Business Development and Investor