- A second patient also showed clinical improvements in the Positron Emission Tomography (PET) imaging analysis, neurologic exam, and in the Timed 25-Foot Walk test, following three months of treatment. These findings are consistent with the results obtained from the first patient following 3-months of treatment, as previously announced on March 10, 2022.
- The PET imaging data from the second SPMS patient was conducted at a different hospital, yet the data confirms the previously reported findings of the PET imaging of the first patient, which was conducted at the Brigham and Women's Hospital (BWH) in Boston.
- Based on the safety data, clinical evaluation, and confirmatory PET imaging data from these two patients, the FDA has allowed enrollment of an additional eight eligible SPMS patients to receive the same intranasal Foralumab therapy under an Intermediate Size Expanded Access Program.
New York, 8 June 2022– Tiziana Life Sciences (Nasdaq: TLSA) ("Tiziana" or the "Company"), a biotechnology company enabling breakthrough immunotherapies via novel routes of drug administration, today reported positive clinical results from the second patient with Secondary Progressive Multiple Sclerosis (SPMS) in the ongoing study as part of an expanded access program at the Brigham and Women’s Hospital (BWH), Boston, MA. These results confirm the previously reported data, from the first SPMS patient after three months of treatment of the first SPMS patient. The treatment with foralumab, a fully human anti-CD3 monoclonal antibody, was well-tolerated and improved clinical and PET imaging analyses.
The second patient, a young male in his 40s, was diagnosed with SPMS in 2014. Since then, the disease has been progressive, resulting in an accumulation of disability. Following completion of three months of treatment with intranasal foralumab (50 mcg; three times a week for two weeks, followed by one week off treatment), the patient showed improvement as measured by PET imaging, to assess inhibition of microglial activation, and by neurologic examination. Approximately 10-30% reduction in PET signal was seen across brain regions (including cortex, thalamus, white matter, and cerebellum) in the second SPMS patient, which is comparable to the PET changes seen in the first SPMS patient following three months of treatment with intranasal foralumab. Clinically, the Timed 25-Foot Walk test and neurologic exam were also improved. Both the first and the second patient are continuing with the treatment and are in their 13th and 4th months of treatment, respectively.
Dr. Kunwar Shailubhai, Chief Executive Officer and Chief Scientific Officer of Tiziana Life Sciences, commented, "We are excited about the positive clinical responses seen in 2 out of 2 SPMS patients treated so far. Clinical data from both patients further validate our novel intranasal therapy with foralumab, which seems to overcome the blood-brain barrier to allow therapeutic action of the drug."
The favorable safety, tolerability, and clinical responses from the first two SPMS patients were submitted to the U.S. Food and Drug Administration (FDA). The agency has now allowed Tiziana to treat an additional eight SPMS patients. Although the original dosing regimen with intranasal therapy with foralumab will remain the same (50 mcg; three times a week for two weeks, followed by one week off treatment), the revised dosing regimen has a provision for dose escalation up to 100 mcg (MWF) as an option to improve clinical benefit.
Dr. Howard Weiner, MD, Director of the Multiple Sclerosis Program at BWH and Chairman of Tiziana's Scientific Advisory Board, commented "We are very pleased by both the biological and clinical improvement observed in the second patient after treatment with intranasal Foralumab for three months, which provides confirmation that the intranasal dosing modulates the systemic immune response and in turn dampens brain inflammation. It is encouraging to see the consistency of response between the first and second patient and that the treatment was well tolerated."
Tanuja Chitnis, MD, Principal Investigator and Professor of Neurology at Harvard Medical School (HMS) and senior neurologist at BWH and Massachusetts General Hospital added, "Therapies to slow progression in multiple sclerosis are much needed as there are only a few options for non-active SPMS. I look forward to treating more patients under this same protocol."
Tarun Singhal, MD, Director of PET Imaging Program in Neurologic Diseases, associate neurologist and nuclear medicine physician at BWH commented, “Our current analyses suggest a consistency of response to intranasal foralumab, across the first two SPMS patients. We were also able to harmonize data across scanners and institutions, which has yielded very encouraging results. We look forward to our continued investigations of foralumab in SPMS patients, using additional PET analytical approaches.”
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 while targeting the T-cell receptor, orally administered foralumab modulates immune responses of the T-cells and enhances regulatory T-cells (Tregs), thereby providing therapeutic benefit in treating inflammatory and autoimmune diseases without the occurrence of potential adverse events usually associated with parenteral mAb therapy. 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. 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.
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.
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