Archivel Farma: Encouraging Results At The End Of Phase I Of Clinical Trials With The RUTI(R) Vaccine
Published: May 19, 2009
The RUTI® vaccine is being developed for the prevention of active tuberculosis in individuals infected with Mycobacterium tuberculosis, the bacillus responsible for this illness in humans. A third of the world’s population, that is, more than 2 billion people, is infected with the bacillus. For most of these people the infection will remain in a latent state, but 10% will develop the illness during their life. In 2007, 1.8 million people died from tuberculosis in the world.
The objectives of the double blind, randomised and placebo-controlled Phase I clinical trial were to study the tolerability and immunogenicity of four increasing doses of the RUTI® vaccine (5, 25, 100 and 200 micrograms of drug substance) in healthy volunteers. The trial took place in the Germans Trias i Pujol Teaching Hospital, (Badalona, España), with Prof. Cardona and Prof. Costa as principal researchers.
The trial included 24 healthy volunteers, who were examined regularly over a period of six months after two identical doses of RUTI® or a placebo were administered, 28 days apart.
The vaccine was well tolerated at all the doses administered, with no signs of systemic toxicity being detected. In some individuals certain adverse reactions were observed at the injection site, which is to be expected for a vaccine such as RUTI®, but it was not considered that these constitute an obstacle to continuing its clinical development. Prof. Costa, Head of the Phase I unit at the Germans Trias i Pujol Hospital tells us “the results of Phase I lead us to conclude that RUTI is safe and tolerated at the doses tested and that we can continue with the planned clinical development.”
The vaccine triggered a clear immunological response against a variety of antigens commonly found in clinically relevant stocks of Mycobacterium tuberculosis. “The specific response we observed is very significant and provides us with arguments for thinking that we will be able to demonstrate the expected effectiveness when we test it with infected persons”, stated Prof. Cardona.
Archivel Farma is currently focusing on designing the development plan for Phase II, which is expected to start at the end of 2009. As part of this process, the company recently met a Scientific Advisory Committee made up of four internationally-renowned experts in the area of tuberculosis and is holding consultation meetings with leading regulatory agencies concerning the development of vaccines in Europe. The objective of Phase II will be to evaluate the tolerability, immunogenicity and effectiveness of the RUTI® vaccine in individuals with latent tuberculosis infection.
RUTI® was developed by Archivel Farma with the collaboration of the Germans Trias i Pujol Health Sciences Research Institute and the Germans Trias i Pujol Teaching Hospital (Badalona, Spain).
Latent tuberculosis infection is currently treated with antibiotics over a 6-9 month period. Due to the long period of use, up to 50% of persons give up treatment. The antibiotics used also have the potential to cause toxicity in the liver, which requires regular monitoring during treatment. Due to these factors, the current treatment has a low level of effectiveness.
Based on the results obtained with RUTI until now, treatment would be more effective through the administration of antibiotics for just one month, followed by two injections of the RUTI® vaccine.
The dynamic hypothesis, proposed by Prof. Pere-Joan Cardona, Scientific Officer of Archivel Farma, states that latent tuberculosis infection is maintained through the constant re-infection of the lungs by inhalation of endogenous infectious aerosols. It is predicted that treatment with antibiotics followed by two injections with the RUTI® vaccine will be sufficient to prevent re-infection by the inhaled bacilli.
About Archivel Farma S.L.
The biopharmaceutical company Archivel Farma S.L., which is developing the RUTI® vaccine for the treatment of Latent Tuberculosis Infection, was founded in 2005. It is financed by the company Archivel Technologies S.L. and the venture capital fund FonsInnocat, administered by bcnHighgrowth. The development of the RUTI® vaccine, that originated at the public hospital Hospital Universitari Germans Trias i Pujol (Badalona, Spain) has also been supported by the public foundation Fundació Institut d’Investigació en Ciències de la Salut Germans Trias i Pujol, the CIDEM (Centre for Innovation and Entrepreneurial Development of the Generalitat of Catalonia), the CDTI (Centre for Industrial Technological Development) and ENISA (National Innovation Company S.A.).
A first milestone in the development of the RUTI® vaccine began in 2000, when Dr Pere-Joan Cardona, co-inventor of the vaccine and Chief Scientific Officer of Archivel Farma, reached an agreement with the company Archivel Technologies S.L., a company funded and chaired by Mr José Martínez Martínez. Archivel Technologies S.L. financed the whole project until 2005, when Archivel Farma S.L. was founded. In October 2003, having obtained a patent for RUTI®, the laboratory produced the first batch of the vaccine under GMP conditions. In July 2005, the venture capital fund FonsInnocat joined Archivel Farma S.L. and in March 2007, the company was authorized by the Spanish Agency for Medications and Healthcare Products (Agencia Española de Medicamentos y Productos Sanitarios) to carry out a phase I clinical trial of the vaccine RUTI® in humans.
Archivel Farma S.L. is the first pharmaceutical laboratory to trial a drug against Latent Tuberculosis Infection on humans, placing it at the cutting edge of this sector in research and development terms.