Barcelona, Spain – 21 May 2010. The Lancet this week issued a call to arms to fight tuberculosis which it says has become a neglected disease. Yet, it points out, in reality there is more tuberculosis today than at any other time in history with 2 million deaths in the past year alone and 9 million new infections. It cites the emergence of drug-resistant strains and the confluence of the HIV epidemic, which makes people more susceptible to TB, as being responsible for turning TB into a global public health crisis. More details at http://www.thelancet.com/series/tuberculosis.
Archivel Farma has a novel theory about TB that opens up new ways of tackling it. The current view is that TB lies dormant within people, which is known as Latent TB Infection (LTBI). However, Professor Cardona, the company’s Chief Scientific Officer, and Head of the Experimental Tuberculosis Unit of the Research Institut Germans Trias i Pujol, believes that this is not the case as it does not explain why it currently takes a nine month course of antibiotics to eliminate a dormant infection. His Dynamic Hypothesis is that TB is constantly re-infecting the patient and swapping from a non-replicating to replicating form – a strategy evolved over hundreds of thousands of years to ensure that it is very hard to get rid of. As the antibiotics are only effective on the replicating version, the Dynamic Hypothesis explains why it takes nine months of antibiotics as this is the time it takes for all the non-replicating bacteria to slowly change to replicating and be eliminated.
He is testing his Dynamic Hypothesis by taking high resolution Tomography scans of patients with LTBI. Under the current Dormant Hypothesis, the lesions in the lungs caused by LTBI should remain static in size and location. According to the Dynamic Hypothesis, the lesions will change in size with some disappearing and others appearing in new locations and the initial results are showing just that.
The Dynamic Hypothesis provides the company with a unique way of treating LTBI by using a combination of antibiotics drugs for a month to eliminate the active TB along with two injections of the company’s new therapeutic vaccine called RUTI® which tackles the dormant form.
Luis Ruiz-Avila, Archivel’s CEO, explains, “TB is either tackled by drugs companies or by vaccine companies. We are the only company that is using both to cut the treatment time down from nine months to just one. This provides a tremendous opportunity to tackle the very serious problem of TB as, for the first time, there is now a cost effective means to tackling the reservoir of TB that is present in one third of the world’s population. A long and expensive nine month treatment is always going to have problems especially in poorer countries where it is mainly prevalent and where the chances of reinfection are very high. Our new regime of a short course of tablets and two injections will be much easier for people to understand and comply with so the problems of not completing the nine month course and resulting drug resistance are eliminated and reinfection can be reduced due to the immunity provided by the vaccine.”
The RUTI vaccine is produced from Mycobacterium tuberculosis, the strain that actually produces TB. Uniquely, the company cultures the bacteria under conditions that mean that most of the bacteria turn into the hard to treat non-replicating form. This means that resulting vaccine stimulates the body to target this form in particular. The company is hopefully that it will also confer long term immunity to LTBI, which will be the subject of future trials. Meantime, the Phase I trial has been successful completed and the Phase II clinical trial of Archivel’s combination treatment for LTBI will be starting shortly in South Africa and includes patients with HIV who are particularly susceptible to developing active TB as their HIV-compromised immune systems are less able to win the battle with the re-infecting TB.
