10th Sep 2019 14:34
(Alliance News) - Tiziana Life Sciences PLC on Tuesday said data from its phase 1 trial of Foralumab showed the drug "was well-tolerated at all doses" and produced a positive biomarker trend.
Shares in Tiziana were up 31% at 72.00 pence in London.
Foralumab is intended to treat autoimmune and inflammatory diseases and induced a positive trend in biomarkers for immunomodulation - control of the immune system - and anti-inflammation. This was consistent with pre-clinical studies.
A biomarker is something measurable in the body, like a gene or a certain molecule, which indicates a physical state. In this case, for example, these biomarkers indicated modulation of the immune system and anti-inflammation.
Howard Weiner, a member of scientific advisory board of Tiziana Life Sciences, said: "Nasal administration of Foralumab is a revolutionary approach to treat patients with neurodegenerative diseases such as progressive [multiple sclerosis] and amyotrophic lateral sclerosis. Extensive data from animal studies with intranasal delivery of anti-CD3 demonstrate that this route of administration induces anti-inflammatory and immunomodulatory effects. This study demonstrates for the first-time that nasally administered Foralumab, at the identified optimal dose of 50 milligrams, induces immunomodulatory effects capable of providing clinical benefit to treated subjects. This is a major accomplishment providing the scientific rationale to move forward with further clinical development of nasally administered Foralumab in patients with neurodegenerative diseases.
"Both oral and nasal administration routes are physiologic approaches to stimulate the mucosal immune system to induce disease modifying immunomodulation. Our immediate focus is on developing Foralumab for treatment of pro-MS."
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