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Archivel Farma Will Present The Results Of The Phase 1 Clinical Trials Of The RUTI(R) Vaccine At The Atlanta Biotechnology Industry Organization (BIO) International Convention

5/14/2009 1:32:57 PM

Barcelona, 14 May 2009. For the third consecutive year, Archivel Farma will attend the Bio International Convention to be held this year in Atlanta, the United States, from 18 to 21 May.

At the convention, Archivel Farma will present the results of Phase 1 clinical trials carried out on healthy volunteers, in which they tested the tolerability and immunogenicity of RUTI®, its new polyantigenic vaccine to treat latent tuberculosis infection. The presentation, supported by ICEX (Spanish Institute for Foreign Trade) and Biocat, BioRegió de Catalunya, will take place in the meeting areas of the Spain pavilion on Tuesday 19 May at 12:00.

The presentation will be given by Prof. Pere-Joan Cardona, co-inventor of the vaccine, Chief Scientific Officer of Archivel Farma and Head of the Experimental Tuberculosis Unit of the Germans Trias i Pujol Health Sciences Research Institute, Badalona, Spain. The RUTI® vaccine, the result of collaboration between Archivel Farma and the Experimental Tuberculosis Unit, will provide a more effective method of treatment of latent tuberculosis infection, moving from the current treatment with antibiotics for 6 to 9 months to a treatment with antibiotics for just one month, followed by two injections of the vaccine.

In presenting the results of Phase 1, Archivel Farma ends the initial launch stage of the company and opens a new stage which, under the leadership of Dr José Luis Cabero, recently appointed Managing Director, will be focused on consolidating the company’s business plan.

Archivel Farma will use the opportunity provided by its presence in Atlanta to present its strategic plan for 2009-2011. The objectives of this plan are based on three axes: continuing the clinical development of the RUTI® vaccine, starting Phase II at the end of 2009, reinforcing its portfolio of projects, and positioning its production plant in the market of services for third parties. To attain its strategic objectives, the company will soon begin a second round of funding.

About RUTI®

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 biopharmaceuticals company Archivel Farma S.L. which is developing the RUTI® vaccine was founded in 2005. The project originated in a public institution (Germans Trias i Pujol Teaching Hospital) and is financed by the company Archivel Technologies S.L. and the venture capital fund FonsInnocat. The development of RUTI® has been supported by the Germans Trias i Pujol Foundation and Institute for Health Sciences Research, 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.).

This collaboration began in 2000, when Dr Pere-Joan Cardona, inventor of the vaccine and research director, 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 (Good Manufacturing Practices). In July 2005 the venture capital fund FonsInnocat joined Archivel Farma S.L. In March 2007, the company was authorised by the Spanish Agency for Medications and Healthcare Products (Agencia Española de Medicamentos y Productos Sanitarios) to carry out Phase I of the clinical trials on 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.

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