Tiziana Life Sci PLC - Submission of a Patent Application for Foralumab
THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF REGULATION (EU) NO 596/2014
("Tiziana" or the "Company")
Tiziana Announces Submission of a Patent Application for
· Nasal administration with Foralumab could potentially modulate or stimulate immune system to suppress cytokine storm and reduce respiratory failure in
· Nasal administration of Foralumab may be combined with other anti-viral drugs to improve treatment efficacy
Tiziana has a worldwide exclusive license for nasal administration of Foralumab and other anti-CD3 mAbs for the treatment of neurodegenerative and other diseases. The Company previously announced development of a robust formulation and delivery of Foralumab using a nasal spray device and the successful completion of a Phase 1 trial demonstrating that the treatment was well-tolerated and showed positive immunomodulatory effects as measured by biomarker analysis (https://www.tizianalifesciences.com/news-item?s=2018-11-28-tiziana-announces-initiation-of-phase-1-clinical-trial-with-nasal-administration-of-foralumab-a-fully-human-anti-cluster-definition-3-monoclonal-antibody-anti-cd3-mab-in-healthy-volunteers).
Additionally, Tiziana also reported the successful completion of a Phase 1 trial with oral administration of Foralumab, demonstrating that the treatment was well-tolerated up to a 5 mg dose (https://www.tizianalifesciences.com/news-item?s=2020-01-09-tiziana-reports-phase-1-clinical-data-demonstrating-oral-treatment-with-foralumab-a-fully-human-anti-cd3-monoclonal-antibody-is-well-tolerated-in-healthy-volunteers). Importantly, both clinical studies conducted at the
"Nasal administration of Foralumab is a potentially transformative immunomodulatory approach for treating patients with a variety of human diseases. Results from animal studies, conducted in our laboratory have established that nasal administration of anti-CD3 induces regulatory T cells that suppress inflammation and ameliorate diseases in animal models. This scientific advancement provides the basis to move forward with clinical development of nasally administered Foralumab in COVID-19 disease," commented
"Our proprietary immunotherapeutic approach using nasal, inhalation and oral administration of mAbs are novel and promising therapies that stimulate or modulate the immune system so that T regulatory cells (Tregs) are supercharged to inhibit inflammation. The common underlying concept in these alternative delivery approaches is to strengthen one's own body defense to fight against inflammation in these diseases. Being a fully human anti-CD3 mAb, we believe Foralumab is most suitable for immunotherapies, as it does not produce an immune response unlike other humanized anti-CD3 mAbs" commented
The person who arranged for the release of this announcement on behalf of the Company was Dr
Foralumab (formerly NI-0401), the only entirely human anti-CD3 mAb, shows reduced release of cytokines after IV administration in patients with Crohn's disease with decreases in the classic side effects of cytokine release syndrome (CRS) and improves the overall safety profile of Foralumab. 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, 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). Based on animal studies, the nasal and oral administration of Foralumab offers the potential for the immunotherapy of autoimmune and inflammatory diseases in a safe manner by the induction of Tregs.
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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