- Archivel Farma, owner of the vaccine, has started a Phase IIa clinical trial to assess the safety and immunogenicity of RUTI® in patients affected by multidrug-resistent tuberculosis (MDR-TB).
- Dr Pere-Joan Cardona, inventor of RUTI®, and Olga Rué, general director of Archivel Farma, travel to India to explore collaborations for the development of the vaccine in that territory.
Barcelona, October 19, 2017. RUTI®, developed by Archivel Farma, is one of the 9 TB vaccine candidates whose development progress has been analyzed by World Health Organization (WHO) experts in the meeting held 3 and 4 October in Geneva. The meeting, which involved 70 experts and observers –academics and researchers, politicians and health managers, and representatives of the pharmaceutical industry– also aimed to present and discuss the so-called Preferred Product Characteristics (PPCs) for the TB vaccines. The PPCs are a set of characteristics that any medical product has to comply if it wants to obtain a WHO recommendation and the required pre-qualification for being acquired by the agencies of the United Nations system.
“For Archivel Farma, participation in this meeting has been very important, because it has allowed us to validate the adjustment of our product to the characteristics that WHO experts consider should have a TB vaccine, and to confirm that our therapeutic approach differentiates us from other projects”, said Olga Rué, general director of Archivel.
Archivel Farma is focusing the RUTI® development in the treatment of multidrug-resistant TB (MDR-TB), defined as resistance to the antibiotics isoniazid and rifampin, which are increasingly suffering TB patients. 50% of patients with MDR-TB (about 480,000 patients worldwide, to which we must add the 100,000 patients resistant to rifampicin [RR-TB], according to WHO estimates) do not respond to the more than one year treatment, and about 250,000 of them end up dying. The combined action of RUTI® with antibiotic treatments has proven, in tests carried out on animal models animals, its ability to generate a polyantigenic response that significantly reduces the infectious load, a fact that allow predict that in humans the cure time will be shorten and the number of patients who will respond positively to treatment will increase.
At the Geneva meeting, Dr. Pere-Joan Cardona, head of the Experimental Tuberculosis Unit of the Germans Trias i Pujol Research Institute (IGTP) and inventor of the RUTI® vaccine, presented to the WHO experts the results of the different pre-clinical trials and clinical studies carried out so far with the RUTI® vaccine; and also communicated the start of the recruitment of patients with MDR-TB for a Phase IIa trial that Archivel Farma has launched this past May in the Netherlands and that will have a second center in a country in Eastern Europe.Download the complete press release (Spanish)