Spain's Archivel Farma is testing a therapeutic vaccine that could help in the fight against latent tuberculosis.
The treatment, called RUTI, is being tested in conjunction with an antibiotic and is about to be studied in patients in a South African Phase II trial. The trial will enroll 96 individuals with or without concomitant HIV infection. FierceVaccines spoke with Professor Pere-Joan Cardona (pictured, chief scientific officer at Archivel, and company CEO Luis Ruiz about RUTI, which is the only product the company has in the clinical stage.
Treating latent TB has proven problematic and time-consuming--something that leads to low compliance. Cardona and Ruiz likened the disease model to an iceberg--one can see only the tip of the problem. In 2007, there were 9.3 million cases of active TB; however, 100 million are infected with the latent form of the disease each year, and most are unaware they have it. Furthermore, only 10 percent will develop the active form of the disease. For those co-infected with HIV, the chances of the latent form becoming active are much higher, Cardona and Ruiz said. This is why Archivel wants to develop a vaccine especially for such immunocompromised patients.
According to Archivel, 66 of the 88 active pipeline drugs for TB are designed to treat the disease as its primary indication, and another 13 are prophylactics. But Archivel is using a unique approach that combines a one-month course of antibiotic to eliminate the bacteria and two injections of the company's RUTI vaccine that stimulates the body's immune system. This combination reduces the treatment time from nine months to one, is easier to manage, less expensive, more effective and more likely to done completely, according to a company statement.
In a Phase I trial conducted in Spain, the combination was found to be safe and well-tolerated. Ruiz told FierceVaccines that the company hopes to have results from the South Africa trial by the end of the year. The company chose that country because of the high rate of co-infection of HIV and latent TB. If the results of the trial are positive, Archivel hopes to start Phase III studies during the second half of 2011. Ruiz said that there are no current plans to increase its staff size from 16 full-time employees--but that could change if RUTI moves to Phase III.
The company expects to expand its pipeline as part its strategic goals of focusing on biologicals that act as immunomodulating agents, Ruiz told FierceVaccines. It also plans to explore other uses of RUTI itself. Because it acts as an immunomodulating agent, RUTI could work in diseases with autoimmune components, such as psoriasis.
- see Archivel's release on the South African trial