RCS - Tiziana Life Science - TLSA Enrolls Second Patient in Ongoing SPMS Trial
10/01/2022 13:05
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RNS Number : 9298X Tiziana Life Sciences PLC 10 January 2022
Tiziana Enrolls Second Patient in Ongoing Intranasal Foralumab Evaluation for
Secondary Progressive Multiple Sclerosis
- Clinical data from the first patient, after completing 3 out of 6
months, suggest that the treatment was well tolerated with a favorable
clinical response
- FDA allows for continued enrollment under the Individual Patient
Expanded Access Program
New York, January 10, 2022 - Tiziana Life Sciences (Nasdaq: TLSA) ("Tiziana"
or the "Company"), a biotechnology company enabling breakthrough
immunotherapies via novel routes of drug delivery, is pleased to announce that
the U.S. Food and Drug Administration (FDA) allowed enrollment of a second
patient in the ongoing clinical treatment of secondary progressive multiple
sclerosis (SPMS) with intranasally administered foralumab, a fully human
anti-CD3 monoclonal antibody, at the Brigham and Women's Hospital (BWH),
Harvard University, Boston, MA.
Dr. Kunwar Shailubhai, Chief Executive Officer of Tiziana noted, "We have been
systematically building a database of evidence to support both the safety and
clinical potential of intranasal and oral forms of foralumab in close
collaboration with the FDA, and during 2022 plan to initiate several new
trials across areas of large unmet need, including MS, Crohn's Disease, and
Type 1 Diabetes. Today's update marks important progress in the advancement of
our MS program, and supports our novel approach to provide local, rather than
systemic delivery of antibodies."
The first patient treated under this program completed 3 out of 6 months of
dosing. Interim data suggest that the treatment was well-tolerated with a
favorable clinical response. As part of the regulatory process, three-month
safety data were submitted to the FDA, seeking permission to treat an
additional patient under an Individual Patient Expanded Access Investigational
New Drug Application (IND), which has been allowed. Treatment of the second
patient is expected to begin during January 2022 with interim clinical data
after 3 out of 6 months of treatment expected in April 2022. The treatment
plan will remain unchanged as per the original IND. The Investigators at BWH
will be monitoring detailed safety, neurological, and Positron Emission
Tomography (PET) to evaluate microglial activation in this patient.
Modification of immunological and neurodegenerative markers will also be
included as part of the standard investigation to be conducted by BWH.
The ongoing treatment of the first patient continues, and six months of dosing
is expected to be completed by the end of March 2022. To date, this patient
has not shown signs of treatment intolerance or toxicities and appears to be
responding well to treatment. The brain imaging data, as analyzed by PET, show
reduction in microglial cell activation. Published PET studies have shown an
increase in activated microglial cells in patients with SPMS, and that their
increased presence in the brain is associated with higher scores on the
Expanded Disability Status Scale (EDSS), a scale that is widely used to assess
cognitive disability(1). Consistent with these findings, Tysabri®
(natalizumab) (NASDAQ: BIIB (https://investors.biogen.com/) ), an approved
drug for treatment of MS, is also believed to act via reduction in microglial
activation.
Howard Weiner, M.D., Director of the Multiple Sclerosis Program at BWH and
Chairman of Tiziana's Scientific Advisory Board, commented, "The potential for
intranasally administered foralumab to suppress microglial activation is a
promising and novel approach to provide a potentially safe treatment of SPMS
that currently has no effective treatment. We are extremely pleased with the
tolerability of the treatment seen to date as well as with the positive
clinical responses observed after completion of three months of dosing in the
first patient, and we look forward to clinical data after completion of six
months of treatment."
Tanuja Chitnis, M.D., Principal Investigator and Professor of Neurology at
Harvard Medical School and senior neurologist at BWH and Massachusetts General
Hospital added, "New treatments for progressive MS are urgently needed.
Intranasal foralumab could revolutionize treatment for this disabling form of
disease."
About Foralumab
Foralumab (formerly NI-0401), the only entirely human anti-CD3 mAb, shows
reduced release of cytokines after IV administration in healthy volunteers and
in patients with Crohn's disease. In a humanized mouse model (NOD/SCID
IL2γc-/-), it was shown that whilst targeting the T cell receptor, orally
administered foralumab modulates immune responses of the T-cells and enhances
regulatory T-cells (Tregs) and thus provides therapeutic benefit in treating
inflammatory and autoimmune diseases without the occurrence of potential
adverse events usually associated with parenteral mAb therapy (Ogura M. et
al., 2017. Clin Immunol.183:240-246). Once a day treatment for 10 consecutive
days with intranasal foralumab was not only well tolerated but it also
produced strong clinical responses in COVID-19 patients (Moreira et al., 2021.
Front Immunol. 2021; 12: 709861). 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.
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 enquiries:
United Kingdom:
Tiziana Life Sciences plc +44 (0)20 7495 2379
Gabriele Cerrone, Chairman and founder
United States:
Irina Koffler
LifeSci Advisors, LLC
646.970.4681
ikoffler@lifesciadvisors.com
Cited Reference
1. Politis M, et al., Increased PK11195 PET binding in the cortex of patients with MS correlates with disability. Neurology. 2012; 79(6): 523-30
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