Full Press Release Details
Sciences Announces Updated Clinical and PET Scan Findings for Intranasal Foralumab in Two New Multiple Sclerosis Patients
NEW YORK, January 08, 2024 -- Tiziana Life Sciences Ltd. (Nasdaq:
TLSA) ("Tiziana" or the "Company"), a biotechnology company developing breakthrough neuro-immunomodulation therapies,
today announced positive findings have been seen in a total of six out of eight Intermediate Size Patient Population Expanded Access (EA)
patients. These patients have shown improvements in fatigue scores measured by the Modified Fatigue Impact Scale (MFIS). PET scan findings
showing a reduction in microglial activation was also seen in the six patients with MFIS score improvement at the three-month evaluation
period. PET scan findings for two additional EA patients (10 total) are planned to be available in late January.
Tarun Singhal, M.B.B.S., M.D., Director
of PET Imaging Program in Neurologic Diseases at Brigham and Women's Hospital, a founding member of Mass General Brigham Healthcare
System, and Associate Professor of Neurology at Harvard Medical School, commented, "Upon review of the baseline and three-month
[F-18] PBR06 PET scans of the two new na-SPMS EA patients, a qualitative reduction in microglial activity was seen in one of two new patients.
When combined with my assessment of the first six EA patients at three-months, a total of six out of the eight suggested a reduction in
qualitative microglial PET signal. These findings are promising from an imaging standpoint and further studies are needed to confirm them
using additional quantitative approaches."
"The EA patient having a qualitative improvement in their PET
scan also improved in their Modified Fatigue Impact Scale," stated Dr. Tanuja Chitnis, M.D., Principal Investigator and Professor
of Neurology at Harvard Medical School and senior neurologist at Brigham and Women's Hospital. "Six out of the eight na-SPMS
EA patients studied so far have seen measurable clinical improvement in their fatigue. I am excited to lead the effort to replicate these
findings in the ongoing Phase 2 dose-ranging, randomized, placebo-controlled clinical trial."
Gabriele Cerrone, Chairman, acting CEO and founder of Tiziana Life
Sciences noted "We've seen continued clinical and qualitative PET scan improvement over time in patients with na-SPMS where
intranasal foralumab targets inflammation in the brain. It is my expectation that we will rapidly progress our ongoing Phase 2 trial of
intranasal foralumab, given the encouraging results seen so far under the EA IND
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.
The non-active SPMS intranasal foralumab Phase 2 trial dosed its first patient in December of 2023. Immunomodulation by nasal anti-CD3
mAb represents a novel avenue for treatment of neuroinflammatory and neurodegenerative human diseases.1,2
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. Actual results may
differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties
related to market conditions and other factors described more fully in the section entitled Risk Factors' in Tiziana's
Annual Report on Form 20-F for the year ended December 31, 2022, and other periodic reports filed with the Securities and Exchange Commission.
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
For further inquiries:
Tiziana Life Sciences Ltd
Paul Spencer, Business Development and
+44 (0) 207 495 2379
email: info@tizianalifesciences.com
LifeSci Advisors, LLC