The biotechnology company Archivel Farma, a CataloniaBio & HealthTech member, has promoted the design and implementation of the Phase IIb clinical study CONSTAN to explore the effectiveness and safety of concomitant administration of RUTI® immunotherapy with standard treatment in patients suffering from pulmonary tuberculosis (TB) together with Dra. Cristina Vilaplana, head of the Tuberculosis Unit Experimental from the Germans Trias i Pujol Research Institute (IGTP), as a Principal Investigator. The study has been approved by the Spanish Agency of Medicines and Medical Devices (AEMPS), and it is planned to include the first patient (FPFV) in early January 2022.
The clinical trial, led by Archivel Farma, will be conducted in collaboration with the Microbiology Service of the Germans Trias i Pujol Hospital, also CataloniaBio & HealthTech members, and aims to recruit 56 patients from eight Catalan Healthcare Centres. If proven effective, this new therapeutic option could be used as a first therapeutic resource in newly diagnosed pulmonary TB patients, in order to reduce the bacillary load in the lung more quickly than the current standard treatment. In parallel, the RUTI® vaccine is being administered in two other clinical trials as TB treatment adjuvant in India and Ukraine.
Archivel Farma is a biotechnology company founded in 2005 in Barcelona. Its activity is focused on the development the RUTI® vaccine for different indications up to advanced clinical phases and, thus, be able to license it to other pharmaceutical companies that can bring it to market so that it will be accessible to a greater number of people. Currently, it has a team of more than 20 professionals and has its own manufacturing plant certified with GMP (Good Manufacturing Practices) for the production and release of sterile and biological research products, their packaging and quality control.
Photo: Cristina Vilaplana, Pere-Joan Cardona, Olga Rué
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