Idiopathic Lymphopenia

A multi-cohort study in patients with low CD4+ counts and a history of opportunistic infections, this study will be designed to document specific immune responses.
Conducted in coordination with the US National Institutes of Health which is providing partial financial support, the investigation is expected to be conducted in the U.S., Canada and elsewhere and will initiate in 2H 2008.

Tuberculosis (TB)

With support and encouragement from a major European non-profit research institution, Cytheris is currently in discussions regarding the initiation of a Proof of Concept study of IL-7 as a potential treatment for tuberculosis. The study would be conducted in Eastern Europe where investigators have had some success in treating Multidrug-Resistant tuberculosis (MDR-TB) with high doses of IL-2, but with poor clinical tolerance due to acute leak capillary syndrome.

Tuberculosis is currently a global health problem of monumental proportions, with approximately 2 billion people out of the 6 billion people in the world now infected with Mycobacterium tuberculosis, firmly establishing TB as one of the most severe global health problems. The World Health Organization (WHO) estimates that each year about 8 million new cases of TB develop and 2 million people die of the disease, making it a leading cause of death in the developing world. This dramatic increase in prevalence is in part due to the fact that when the immune system is weakened, the bacteria - which reside walled off in cells in the lungs - emerge to cause active TB. This occurs most prominently when individuals contract HIV/AIDS, which severely weakens the immune system or are otherwise placed in an immune-compromised state.

The development of anti-TB specific immune response originates in the lymph nodes and it is known that IL-7 sends T-cells to lymph nodes, otherwise known as “homing.”

Furthermore, there is considerable suggestive data from in vivo studies supporting the potential of IL-7 for use in treating TB. These include:

• In non-human primates, IL-7 treatment shows a “reboost” of the specific immune response induced months before by an experimental vaccine
  
  
• A positive experimental model in mice
  
  
• Immunostimulating effect with support of antigen specific T cells
  
  
• Anti-TGFb activity (anti-immunosuppressive and anti-fibrosis)
  
  
• More prone to Th-1 response

Assuming discussions with investigators and supporting institutions are successful, Cytheris plans to initiate the investigation in 2H 2008.