(Sharecast News) - Biotechnology company Tiziana Life Sciences announced the completion of its clinical study in Brazil on Monday, investigating nasally-administered Foralumab - its proprietary human monoclonal antibody - either alone or in combination with orally administered dexamethasone in Covid-19 patients.
The AIM-traded firm said the study was completed in collaboration with scientific teams at the Harvard Medical School of Boston, Santa Casa de Misericórdia de Santos Hospital of Santos, Brazil, and São Paulo-based contract research organisation Intrials.
It said the last patients in the trial received their final dose on 21 December, with the topline data from the trial expected to be available during January.
Because Covid-19 entered through the nasal and respiratory passage, the proprietary nasal formulation and nasal delivery of Foralumab was described by the board as an "innovative approach" to provide immediate relief to Covid-19 patients.
Dr. Howard Weiner (the Robert L. Kroc Professor of Neurology at the Harvard Medical School, The clinical study enrolled a total of 39 patients with moderate-to-severe Covid-19, who did not require the use of a ventilator at the beginning of the study.
Tiziana siad the primary endpoint of the study was the safety of the treatment, with secondary endpoints being to evaluate the effect of treatment on disease severity symptoms, nasal tolerance, sense of smell, and biomarkers for disease progression.
The pharmacokinetics of nasally-administered Foralumab were also being evaluated.
Patient-reported outcomes to assess clinical responses related to Covid-19 symptoms, as per US Food and Drug Administration (FDA) guidelines, were also being collected.
"While we expect to get the topline data in January, we are delighted with the positive feedback received from the treated patients," said chief executive and scientific officer Dr Kunwar Shailubhai.
"This is the first-in-class and scientifically logical approach to improve the human immune system by stimulating Tregs to suppress lung inflammation, and to dampen cytotoxic CD8+ T cell responses in the nasal and respiratory tract, the primary sites of the Covid-19 virus."
Dr Shailubhai said the company believed such an approach could potentially provide benefits to patients already infected with Covid-19, and its newly-identified variants.
"Thus, our therapeutic approach to provide rapid relief to patients already suffering with the diseases is particularly important, because vaccination is primarily to prevent Covid-19 infection, but it may not be useful for treatment of Covid-19 patients."
At 1443 GMT, shares in Tiziana Life Sciences were up 13.01% at 103.4p.
18 Jul 2016 08:46