Project Lead(s): Dmytro Butov
After AIDS, tuberculosis (TB) is the most important cause of death from an infectious agent.
Current TB drugs are not effective against multidrug-resistant TB (MDR-TB) and TB associated with HIV, and require long courses of therapy at high cost.
The goal of this project was to conduct a clinical trial to confirm or refute earlier published findings that suggested Immunoxel lozenges, given with TB treatment, improve patient outcomes.
Immunoxel is a low-cost, multi-herbal product manufactured by Ekomed Company (Kiev, Ukraine) that is sold over the counter in almost every pharmacy in Ukraine, as a dietary immunomodulatory supplement.
About 15 years ago, Ukrainian doctors accidentally discovered that, when Immunoxel was used along with TB drugs, it cut down TB treatment time, increased bacillary clearance rate and lowered hepatotoxicity of TB drugs. The efficacy was the same regardless of the type of TB or whether TB existed in the presence of HIV.
The aim of the project was to reproduce Immunoxel results in a larger group of TB patients (n = 360) and to determine whether the outcome of such an intervention would be superior or inferior to ‘sham’ or placebo lozenges without Immunoxel.
Statistical analysis revealed that Immunoxel lozenges produced the clearance of TB bacilli in 65.9% of treated patients, versus 28.8% in the control or placebo group – a highly statistically significant difference.
In addition, two important advantages of the approach, which must be emphasized, were revealed.
First, the time to bacterial clearance was just one month – lightning-fast, compared to the up to two years required to treat MDR-TB patients.
Second, Immunoxel appears to have an equally potent effect regardless of gravity of the disease, meaning that drug-sensitive TB as well as difficult-to-treat resistant strains responded to treatment in the same manner.
Knowledge of the project has been disseminated in conferences and publications.
The project team will be applying for Phase II Transition To Scale funding to help with initiating the commercialization process.
The team feels that, within three years, commercialization of Immunoxel as an immunomodulating supplement, to be given together with standard TB drugs, could result in helping treat 11 million TB patients in six countries where the lozenges are already approved.