Tiziana Life Sci PLC - P2 Trial with foralumab on Severe COVID19 Patients
A subsidiary of FHI 360, FHI Clinical specializes in the clinical development of drugs for infectious diseases (https://www.fhiclinical.com). The company's involvement with COVID-19 includes Phase 1 to Phase 3 clinical trials for vaccines and therapeutics, as well as observational studies to collect data about the characteristics and course of infection. With experience conducting related studies across 16 countries and 43 states in
In this clinical trial, Foralumab will be delivered intranasally through a metered-dose nasal atomization device. Nasal administration of Foralumab is a highly innovative approach to treat patients with autoimmune diseases where the immune system may be dysregulated. Several studies have suggested that there is dysregulation in the immune system of patients with COVID-19.
This randomized, placebo-controlled, double-blind, proof-of-concept study is designed to expand on the preliminary findings of safety, tolerability and efficacy of intranasal administration of Foralumab observed in mild to moderate non-hospitalized COVID-19 patients (https://ir.tizianalifesciences.com/news-releases/news-release-details/tiziana-life-sci-plc-positive-data-nasal-administration). Thus, this study will examine attenuation of pulmonary pathology in hospitalized patients with severe COVID-19. Up to seven sites in
"Our experience is uniquely suited to the needs of this Phase 2 study as we are able to pull from past outbreak experience, including rapid study start-up in research-naïve areas to leveraging existing global research networks and contributing to local health systems," said Ted FitzGerald, FHI Clinical President and CEO. "We excel at addressing the complex aspects of infectious disease trials that require thorough planning and contingency planning."
"We are pleased to move forward with FHI Clinical on our next COVID-19 trial. After a successful proof-of-mechanism trial in mild to moderate COVID-19 outpatients with intranasal Foralumab earlier this year, the next step is to test it in more severe hospitalized patients with pulmonary inflammation," said Dr.
The person who arranged for the release of this announcement on behalf of the Company was Dr.
THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF REGULATION 2014/596/EU (WHICH FORMS PART OF DOMESTIC
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 and improves the overall safety profile of Foralumab. 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, 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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