The Spanish biotech company Archivel Farma has officially begun the clinical trial of its therapeutic vaccine RUTI®, which will be carried out by Clinical Research Network India, a Contract Research Organization specializing in clinical research. The double-blind, randomized, placebo-controlled phase IIb clinical trial will investigate the efficacy of RUTI® as adjuvant of Tuberculosis (TB) chemotherapy and will recruit 90 patients with TB and 50 patients with multi-drug resistant TB (MDR-TB).
The clinical trials will be conducted in two centers in India: the All India Institute Of Medical Sciences (AIIMS) of New Delhi, and the Agartala Government Medical College of Agartala. The first patient in the trial has been recruited on 30 September, 2021 at the All India Institute Of Medical Sciences of New Delhi in India.
“We are very satisfied that after many efforts carried out by all the Consortium members we can begin this clinical trial in such prestigious Indian hospitals and in one of the countries most affected by tuberculosis disease. For Archivel it represents a great milestone since it brings the opportunity to get closer to new clinical findings that are expected to contribute to the future deployment of the RUTI® vaccine worldwide to improve the life of those affected by the disease.” said Olga Rué, Chief Executive Officer of Archivel Farma.
The clinical trial is jointly funded in the STriTuVaD Consortium project by the EC-Horizon 2020 program and the Department of Biotechnology of the Indian Government.
With the recruitment of TB and MDR-TB patients and the beginning of the clinical trial, it will be also possible to use the trial’s information to quantify the predictive accuracy of the UISS computer model developed within the consortium, capable of predicting the individual response of patients with active TB when treated with new therapies.
This information will be essential in the future regulatory qualification of in silico trials methods, which represent a disruptive innovation that could speed up and reduce the costs for the development of more effective therapies for this deadly disease.
“If we can cut the amount of time needed to bring a drug to market, and if we can cut the cost of a single dose, we can make a vaccine that’s affordable for all of the people who need it – comments Dr Epifanio Fichera, Project Manager at Etna Biotech and coordinator of the STriTuVaD project – This is the future of vaccine development.”
The All-India Institute of Medical Sciences (AIIMS) was established as an institution of national importance by an Act of Parliament with the objects to develop patterns of teaching in Undergraduate and Post-graduate Medical Education in all its branches. Twenty-five clinical departments including four super specialty centers manage practically all types of disease conditions with support from pre- and para-clinical departments.
The Agartala Government Medical College (AGMC) is a government medical college located on the lap of Agartala, the capital city of Tripura. The college is attached with the G. B. Pant Hospital, which is the hospital of the college. It is completely run by the Government of Tripura.
ARCHIVEL FARMA is a biotechnology company founded in 2005 in Barcelona (Spain) that works on the development of the RUTI® immunotherapeutic agent, a biological product devised by Dr. Pere-Joan Cardona, from the Germans Trias I Pujol Research Institute, to treat tuberculosis and other diseases susceptible to immunomodulatory interventions. The company’s goal is to develop the RUTI® vaccine for different indications up to advanced clinical phases and license it to companies in the pharmaceutical sector that can bring it to market, making it accessible to the greatest number of people. It has a team of more than 20 professionals and has its own GMP (Good Manufacturing Practices) manufacturing plant for the production and release of sterile and biological research products, their conditioning and quality control.
STriTuVaD – In Silico Trial for Tuberculosis Vaccine Development is a research project funded by the EU’s Horizon 2020 research & innovation program and Department of Biotechnology, Government of India under grant agreement No 777123, and aims to develop the UISS computational model capable of predicting the individual response of patients with active TB when treated with new therapies. www.strituvad.eu