Tiziana Life Sciences plc (NASDAQ:TLSA) (“Tiziana” or the “Company”), a biotechnology company focused on innovative therapeutics for inflammatory diseases and cancers, is pleased to report completion of a Phase 1 clinical study of Foralumab, a fully human anti-CD3 monoclonal antibody (“mAb”), in healthy subjects. The proprietary oral formulation, comprising the lyophilized and stabilized free-flowing powder of formulated Foralumab encapsulated in an enteric-coated capsule, was well-tolerated at all doses tested and there were no drug-related safety issues even at the highest dose of 5 mg in this trial.
This Phase 1 trial, conducted at the Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA, was a single-site, double-blind, placebo-controlled, single ascending dose (“SAD”) study in healthy subjects in which Foralumab was orally administered at 1.25, 2.5 and 5.0 mg per dose as enteric-coated capsules. Each cohort comprised of 4 subjects, of whom 3 received Foralumab treatment and 1 received a placebo capsule. All subjects completed the trial without any safety concerns at any of the doses.
It has previously been shown that orally administered Foralumab to NOD/SCID IL2?c-/- mice (which have human immune systems) with skin xenografts was well-tolerated up to 15 µg/day (n=20; human equivalent dose of 3.66 mg/dose in a 60 kg human) for 5 days then weekly, prevented skin xenograft rejection indefinitely. Clinical studies conducted by other researchers have also shown that oral administration of OKT3, a murine anti-CD3 mAb, was well-tolerated up to 5 mg/day for 5 days to healthy subjects, to patients with nonalcoholic steatohepatitis (“NASH”) for 30 days and to hepatitis C virus (HCV) non-responders for 30 days. Data from a recently completed clinical study indicated that oral administration of OKT3 was well tolerated at 1 mg/day for 30 consecutive doses in patients with moderate-to-severe ulcerative colitis. Importantly, the treatment resulted in clinical responses in 3 out of 6 patients, including one patient with a complete clinical response.
“This is the first-ever study demonstrating that orally administered Foralumab is well-tolerated at all doses up to 5.0 mg/dose. This ground breaking study opens a novel avenue for future development of oral mAb therapeutics ” commented Dr. Howard L. Weiner, a member of the scientific advisory board of Tiziana Life Sciences. Recently, we also successfully demonstrated that nasally administered Foralumab is not only well-tolerated but also produced the desirable immunological responses. He added that “both oral and nasal administration routes are physiologic approaches to stimulate the mucosal immune system to induce disease modifying benefits.”
“We are very pleased with the tolerability of both oral and nasally administered Foralumab” added Dr. Tanuja Chitnis, Professor of Neurology at Harvard Medical School, and study Principal Investigator (PI).
“Successful completion of this study is a significant milestone to validate our proprietary technologies of oral and nasal administration of mAbs, which we believe could potentially be transformational for future development of mAbs therapeutics. We are excited to note that oral administration was well-tolerated and that the treatment did not result in severe toxicities that are commonly observed with intravenous (IV) administration of anti-CD3 mAbs. These findings provide the scientific rationale for our core technologies of oral and nasal formulations of mAb therapeutics, said Dr. Shailubhai, CEO & CSO of Tiziana Life Sciences.
The person who arranged for the release of this announcement on behalf of the Company was Dr Kunwar Shailubhai, CEO & CSO of Tiziana.