The announcement came after the company received approval from the Dutch Ethics Committee and Central Commission on Research Involving Human Subjects (CCMO) to start the double-blind, single-center, Phase 1 trial in the Netherlands. The application for approval was submitted in May.
The study will assess the effects of T20K, Cyxone’s investigational prophylactic (preventive) MS therapy derived from a natural plant protein, intravenously infused in a group of healthy male volunteers.
Previous preclinical trials showed that T20K could inhibit the production of pro-inflammatory cytokines (immune messengers that mediate inflammation) such as IL-2, and effectively reduced clinical symptoms in animal models of MS. Moreover, the therapy was found to have low toxicity, and favorable absorption and distribution in the body.
The main goal of the new trial is to evaluate the safety and tolerability of T20K in humans, following the administration of one or two doses of the compound. During the study, researchers will measure the levels of T20K in the blood of study participants.
The trial is being carried out by Cyxone in collaboration with the clinical research organization QPS Netherlands.
“The start of our first-in-human trial for T20K is a big moment for Cyxone. Thanks to our great team and partners, we are well-advanced in preparations and could start the study as soon as we got the needed approval from the authorities,” Kjell G. Stenberg, CEO of Cyxone, said in a press release.
“With T20K’s natural origin and excellent preclinical safety profile, we look forward to evaluating our candidate’s safety in humans and take another step forward towards transforming the treatment of autoimmune diseases,” Stenberg said.
The trial is now recruiting and screening participants. The first group of healthy male volunteers enrolling in the trial is expected to receive the first T20K dose in July. This may be followed by a second group of study participants treated with two doses of the compound.
Cyxone estimates the trial will be concluded in the second half of 2019. In the meantime, the company said it will make further announcements once the first volunteer enrolling in the trial is dosed, and once the last study participant receives the last dose of T20K.
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