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Unique Features of the Product

Game Changing Technology, with strong indications of being able to reduce the duration of treatment of drug-sensitive TB to one month from the current requirement of six months.

image01Completely eradicates tuberculosis (TB)-causing bacteria from the lungs of experimentally-infected mice and guinea pigs in four weeks (20 doses of 80-100 micrograms).

image01 If combined with half the recommended oral dose of the same drugs, extra-pulmonary site of infection (spleen) is also completely cleared of bacteria, with no relapse over the next four weeks if animals receive no further treatment.

image01 Activates macrophages infected with TB-causing bacteria to mobilize innate bactericidal responses when they pick up inhaled particles (host-directed therapy in addition to chemotherapy).

image01Completely safe for chronic (90-days, repeated daily doses, 5 days/week) inhalation by Rhesus monkeys—also in acute/subacute inhalation safety/toxicity studies in mice.

image01 Potential for “therapeutic isolation” of TB patients who receive inhalations (since some inhaled particles will come out every time they cough), thereby blocking transmission of TB.

image01Potential to reduce total drug intake for successful cure by one order of magnitude, significantly ameliorating toxic/adverse effects.

image01 Potential to reduce total duration of treatment, significantly reducing probability of infecting naïve individuals.

Scientific Basis of the Project

The scientific basis of the project resides in the realization that TB bacteria live and proliferate within lung macrophages, which are the very cells that have evolved to kill microbes landing on the lung surface. If inhaled particles containing anti-TB drugs are picked up by macrophages harboring TB bacteria, a very high drug concentration will develop in close vicinity of the pathogen. Simultaneously, the event of phagocytic uptake will rescue the macrophage from its state of ‘alternative activation’ imposed by the pathogen in order to survive within the phagocyte. Abundant evidence for each of these assertions has been collected over the past years [1-25].