Vancouver, Canada (PRWEB) June 17, 2012
The phase II, placebo-controlled trial, conducted by experts in the field of TB immunotherapy, was set to evaluate the efficacy of tableted, heat-killed Mycobacterium vaccae in tuberculosis patients, including drug-sensitive and drug-resistant TB. The preliminary findings from the completed study were presented last month at Keystone Symposium “Drug Resistance and Persistence in Tuberculosis” held on May 13-18, 2012 in Kampala, Uganda.
Current TB drugs are outdated and not fully effective, especially against multi-drug resistant TB (MDR-TB) and TB with HIV and strenuous and often-toxic treatment regimens lasting up to 30 months are required. Mycobacterium vaccae is a non-pathogenic species of the Mycobacteriaceae family commonly found in the soil and water. It has been investigated extensively as a vaccine or immunotherapeutic agent for treatment of tuberculosis and unrelated autoimmune diseases. M. vaccae is safe: over two decades of clinical studies, including pediatric trials, in more than 20 countries failed to reveal any adverse side-effects. Injectable M. vaccae is approved in 2001 for sale in China as an adjunct immunotherapy to TB drugs. The capsulated version of oral M. vaccae has been successfully tested in 2010 by John Stanford et al., in ten-patient study in Argentina. Immunitor has used its proprietary technology to manufacture tableted version of M. vaccae from two independent GMP sources – one from Europe and another from China. The resulting low-cost M. vaccae tablets are stable at room temperature for several years, without requiring cold chain storage conditions.
The imm02 study, involving more than 120 patients, has shown that daily oral administration of low doses of M. vaccae with TB drugs resulted in clearance of M. tuberculosis in sputum smears within one month. No difference in outcome was seen when easy-to-treat, drug-sensitive TB cases were compared to MDR-TB or HIV-TB – the proportion of converted patients and time to conversion were identical. Almost half of patients in this study had treatment failed MDR-TB and were on palliative care consisting of two 1st line drugs: isoniazid (H) and rifampicin (R). Both M. vaccae sources - courtesy of British Immodulon and Chinese Longcom (subsidiary of Zhifei Biological 300122.SZ) companies - had demonstrated significant sputum conversion rate even though by definition MDR-TB is resistant to H+R drug combination.
“Remarkable anti-TB activity resulting from daily dosing with oral M. vaccae supports the prior study in Argentina. Our results indicate that the duration of MDR-TB therapy can be shortened by as much as twenty-fold and additional studies are now planned to see if the simple two-drug combo with V7 holds the promise. If confirmed, this will revolutionize and transform TB care and control”, said Dr. Dmytro Butov, the Principal Investigator of the study.
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