Vancouver, Canada (PRWEB) October 22, 2011
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 in Argentina.
The “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 “regular”, 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. Another significant observation worthy of note is that the outcome appeared to be the same, regardless whether 1st line or 2nd line TB drugs were used. One pill of Immunitor’s V7 given once-per-day produced other statistically significant clinical benefits such as reversal of TB-associated wasting and fever. No adverse effects were observed throughout the study.
“Remarkable anti-TB activity resulting from daily dosing with 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. In V7 study only 7 out of 20 patients (35%) had first diagnosed, drug-susceptible TB - the remaining patients had difficult-to-treat MDR-TB or TB with HIV. Our results are encouraging and further investigation in a larger population is needed”, said Aldar Bourinbaiar, CEO of Immunitor company.
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 HIV-TB and strenuous 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. The prophylactic M. vaccae trial, the DarDar study, conducted between 2001-2008 among 2013 HIV-infected volunteers in Dar Es Salaam, Tanzania by Professor C. Fordham von Reyn of Dartmouth Medical School and his collaborators in Africa and Finland was reported last year. Vaccae ™ preparation is currently sold in China as immunotherapy for TB by Anhui Longcom Biologic Pharmacy Co., Ltd. Another mycobacterial vaccine is manufactured in India by Cadila Pharmaceuticals. Immunovac ™ was originally developed for leprosy, but was later shown to have favorable therapeutic and preventive benefit against TB. Except study in Argentina, all previous commercial formulations are in injectable form. 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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The information in this release, other than historical information, may be considered forward-looking statements. Projection and other forward-looking statements and management expectations regarding future events and/or financial performance of the Company -- although given in good faith -- are inherently uncertain and actual events and/or results may differ materially.