Vancouver, BC (PRWEB) May 29, 2012
The phase II, placebo-controlled trial, conducted in Ukraine by internationally recognized experts in the field of TB immunotherapy, was aimed to identify the efficacy of tableted, heat-killed Mycobacterium vaccae in TB patients, including re-treated TB, multi-drug resistant (MDR-TB) and TB with HIV co-infection. The preliminary results of the study support findings from a trial published last year in Immunotherapy journal by a clinical team lead by Professor John Stanford and his colleagues Dlugovitzky et al., in Rosario, Argentina.
The outcome of “imm02” study indicates that V7 vaccine is safe, has not produced any adverse effects or reactivation of TB. Concurrent administration of low doses of M. vaccae either with 1st or 2nd line TB drugs resulted in clearance of M. tuberculosis in sputum smears of 77.8% patients as opposed to 19% among placebo recipients in the control group. Sputum conversion occurred fast – only one month of treatment was needed. No difference was seen when drug-sensitive, easy-to-treat TB was compared to treatment-failed TB, MDR-TB or HIV-TB – the proportion of converted patients and time to conversion were identical.
In a separate set of studies daily dose of V7 has been used in 65 treatment-failed MDR-TB patients on palliative therapy consisting of simple two drug combination: isoniazid (H) and rifampicin (R). Both M. vaccae sources, either from British Immodulon (N=37) and Chinese Anhui Longcom (N=28) companies, had demonstrated significant sputum conversion rate even though patients were resistant to H+R combination.
“Remarkable anti-TB activity resulting from daily dosing with oral M. vaccae supports earlier study in Argentina, which has been conducted in drug-sensitive TB patients. The goal of Immunitor was to confirm findings from the original developers of this vaccine and, in so doing, eventually develop an easy-to-administer TB vaccine that could potentially do both, treat and prevent the disease. Our results indicate that conventional TB therapy can be shortened significantly and further investigation in a larger population is needed”, said Dr. Dmytro Butov, the Principal Investigator of this study.
Globally AIDS, malaria and tuberculosis are most common causes of death in developing world, with 9.4 million new cases of TB and 1.7 million people dying each year. Current TB drugs are not fully effective, particularly against multi-drug resistant TB (MDR-TB) and TB with HIV and strenuous and often-toxic treatment regimens lasting for up to 2 years are required.
M. vaccae is the only TB vaccine that has been through phase III trial in last 90 years. Vaccae™ preparation is currently sold in China as an adjunct immunotherapy for TB by Anhui Longcom Biologic Pharmacy Co., Ltd. Except two oral vaccination studies in Argentina and Ukraine, all prior studies were based on injectable formulation. The V7 vaccine made as an ordinary oral pill has obvious advantages and potential to address current challenges – offering a shorter, more efficacious and safer solution. In addition, M. vaccae is inexpensive, made from readily available source, which suits ideally developing countries where TB and HIV are rampant. For additional information on oral vaccine technology pertaining to the mucosal immunity, please visit http://www.immunitor.com.
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