Clinical Accelerator, a full-service contract research organization, is pleased to announce that it has entered into a collaboration with Archivel Farma, for conducting a phase IIa clinical trial for their therapeutic vaccine RUTI® against multi-drug Resistant tuberculosis. The double-blind, randomized and placebo-controlled trial will take place at several specialist tuberculosis sites in the Ukraine alongside with Groningen University Medical Centre in the Netherlands, and will be testing the vaccine’s safety and immunogenicity.
The RUTI® vaccine stimulates host immune effectors directed at bacilli that persist under antibiotic therapy of tuberculosis. It works in tangent with standard antibiotic treatment, improving the efficacy of the standard antibiotic treatment and reducing the chance of recurrence. Clinical safety and immunogenicity has already been proven in healthy volunteers and in individuals with latent tuberculosis infection, both HIV +/ in phase I and II studies. The purpose of the current study is to show that it is safe in patients with multidrug-resistant (MDR-) TB at two different time points of vaccination.
With this study, Archivel Farma aims to evaluate the safety and immunogenicity and to explore the efficacy as the reduction of bacillary load in the sputum of the novel anti-TB vaccine RUTI®, and collect data that could potentially assist in pin-pointing the optimal time to administer RUTI®.
About Clinical Accelerator
Clinical Accelerator is an independent clinical trial management organisation operating principally in Central and Eastern Europe. The organisation offers a broad range of clinical trial services together with dedicated patient enrolment support to worldwide clients in the pharmaceutical, biotechnological, nutraceutical and medical device industries. Clinical Accelerator’s model of operation is designed to achieve significant cost savings for its clients and to guarantee compact timelines for patient enrolment with a firm focus on the quality of clinical trial data.
About Archivel Farma
Archivel Farma is an R&D biotech company that develops immunotherapeutic agents to tackle unmet medical needs. The company was founded in 2005 and has ever since been committed to fighting tuberculosis which affects 10 million people every year.
The Director of Clinical Accelerator, Nik Nikitin MD, PhD says, there are significant unmet medical needs in the management of multi-drug resistant tuberculosis (MDR-TB). A large proportion of MDR-TB cases occur in Central and Eastern Europe where Clinical Accelerator runs its clinical studies. The novel anti-TB vaccine RUTI, which is being developed by Archivel Farma can make an important contribution to the fight against MDR-TB in our region of operation and globally. On behalf of Clinical Accelerator, we will be making every effort to make sure that the study is implemented within compact timelines and with high quality.