Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]
18 October 2023 - 10:12PM
Edgar (US Regulatory)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM 6-K
REPORT
OF FOREIGN PRIVATE ISSUER
PURSUANT
TO RULE 13a-16 OR 15d-16
UNDER
THE SECURITIES EXCHANGE ACT OF 1934
October
2023
Commission
File Number: 001-38723
Tiziana
Life Sciences LTD
(Exact
Name of Registrant as Specified in Its Charter)
9th Floor
107
Cheapside
London
EC2V
6DN
(Address
of registrant’s principal executive office)
Indicate
by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
INFORMATION
CONTAINED IN THIS REPORT ON FORM 6-K
On October
18, 2023, Tiziana Life Sciences LTD (the “Company”) issued a press release, announcing a significant milestone in
the treatment of multiple sclerosis. The U.S. Food and Drug Administration (FDA) has allowed multiple sclerosis patients to take home
and self-administer Intranasal Foralumab, a groundbreaking treatment developed by Tiziana Life Sciences. Delivery Device Training materials
have been developed and refined in collaboration with the FDA, and patients will be trained in the use of the nasal device in accordance
with these materials.
The
Announcement is furnished herewith as Exhibit 99.1 to this Report on Form 6-K. The information in the attached Exhibits 99.1 is
being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934,
or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference in any filing made by the Company
under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, except as otherwise set forth herein or as shall
be expressly set forth by specific reference in such a filing.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned, thereunto duly authorized.
|
TIZIANA LIFE SCIENCES LTD |
|
|
|
|
Date: October 18, 2023 |
By: |
/s/ Keeren Shah |
|
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Name: |
Keeren Shah |
|
|
Title: |
Chief Financial Officer |
EXHIBIT INDEX
3
Exhibit 99.1
Tiziana Life Sciences Announces Allowance
By FDA For At-Home Dosing Of Intranasal Foralumab For Multiple Sclerosis Treatment
| ● | Patients In the Intermediate Size Patient Population Expanded Access (EA)
Program Will Receive Intranasal Foralumab As Part of the At-Home Dosing Initiative |
| | |
| ● | Greater Than 1 year Safety Exposure to anti-CD3 Foralumab Has Been Well-Tolerated |
| | |
| ● | At-Home Dosing Likely to Improve Patient Compliance to Treatment and Outcomes |
NEW YORK, October 18, 2023 --Tiziana Life Sciences Ltd. (Nasdaq:
TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies
via novel routes of drug delivery, is pleased to announce a significant milestone in the treatment of multiple sclerosis. The U.S. Food
and Drug Administration (FDA) has allowed multiple sclerosis patients to take home and self-administer Intranasal Foralumab, a groundbreaking
treatment developed by Tiziana Life Sciences. Delivery Device Training materials have been developed and refined in collaboration with
the FDA, and patients will be trained in the use of the nasal device in accordance with these materials.
Intranasal Foralumab, a novel biologic therapy, has demonstrated remarkable
potential in the management of multiple sclerosis. The FDA's decision to allow patients to self-administer this treatment at home marks
a significant advancement in the accessibility and convenience of care for those living with this challenging condition.
“Traditionally, MS patients have had to visit healthcare facilities
for treatment, which could be inconvenient and burdensome. The FDA's approval for home dosing of Foralumab will transform the way patients
manage their condition, offering them greater control over their treatment schedules and the convenience of receiving care in their familiar
environment” commented Gabriele Cerrone, Chairman, acting CEO and founder of Tiziana Life Sciences on this landmark decision, saying,
"We are elated with the FDA's allowance for home dosing of Intranasal Foralumab. This step significantly aligns with our mission
to make innovative therapies more accessible to patients and ultimately improve their quality of life. We believe that this treatment
approach will revolutionize the way multiple sclerosis patients manage their condition."
Dr. William A. Clementi, Chief Development
Officer of Tiziana commented “Since the beginning of the na-SPMS EA program, patients have been going to the MS clinic at Mass General
Brigham to receive their 3-times a week dosing. Now, these patients will only need to go to the clinic once every 3 weeks. This dosing
and medical evaluation schedule will also be mirrored in our Phase 2a double-blind study, which is due to start in November.”
“Frequent visits to the clinic for
dosing is very difficult for my patients with MS,” noted Dr. Tanuja Chitnis, M.D., Principal Investigator and Professor of Neurology
at Harvard Medical School (HMS) and senior neurologist at Brigham and Women’s Hospital, a founding member of Mass General Brigham
Healthcare System. “The ability for patients to dose themselves at home is truly welcome.”
About Foralumab
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. The non-active SPMS intranasal
foralumab Phase 2 trial is expected to start screening in November 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.
For further inquiries:
Tiziana Life Sciences Ltd
Paul Spencer, Business Development and Investor
Relations
+44 (0) 207 495 2379
email: info@tizianalifesciences.com
Investors:
Irina Koffler
LifeSci Advisors, LLC
+1 646 970 4681
ikoffler@lifesciadvisors.com
| 1 | https://www.pnas.org/doi/10.1073/pnas.2220272120 |
| 2 | https://www.pnas.org/doi/10.1073/pnas.2309221120 |
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