Successful Trial of Oral TB Vaccine Published in Immunotherapy Journal

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Immunitor, Inc., a commercial stage company committed to developing oral therapeutic vaccines, today announced that its second Phase II trial of oral TB vaccine with heat-killed Mycobacterium vaccae (V7) was published in October issue of Immunotherapy journal.

This study is second of two Phase II trials run by Immunitor in Ukraine. The trial was conducted in 41 patients with pulmonary tuberculosis randomized into treatment (N=20) and placebo (N=21) arms to investigate the safety and efficacy of an orally-administered therapeutic TB vaccine (V7) containing 10 μg heat-killed M. vaccae provided by British company Immodulon Therapeutics. Both arms received conventional anti-TB therapy administered along with daily pill of V7 or placebo. The subject population had four categories of TB: drug-sensitive TB (DS-TB); re-treated TB (RTB), drug-resistant TB (DR-TB); and TB with HIV distributed in V7 and placebo arms at 9:4:7:6 and 14:1:6:8 ratios. The mycobacterial clearance in sputum smears was observed in 72.2% (P<0.0001) and 19% (P=0.03) of patients on V7 and placebo. 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 or MDR-TB – the proportion of converted patients and time to conversion were identical. Study found out that oral M. vaccae was safe and has a potential, as an adjunct immunotherapy targeting the mucosal immunity, to improve efficacy and shorten treatment duration of TB chemotherapy.

Globally AIDS, malaria and tuberculosis are most common causes of death in developing world, with 8.6 million new cases of TB and 1.3 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. Despite that only about half of patients can be cured. Lengthy and difficult treatment prompts high rate of non-compliance, which increases the risk of emergence of drug-resistant bacteria. The World Health Organization projects that as many as two million people may develop drug-resistant strains of TB worldwide by 2015 – despite everyone’s efforts to achieve the 2015 Millennium Development Goals related to TB. The fact is, every time we fail to treat TB completely – drug resistance can take hold, dramatically increasing the threat to patient health and the cost of controlling the disease.

"The main conclusion of this trial is that conventional TB chemotherapy can be shortened to as little as one month even in patients with MDR-TB and those with HIV. I am confident that we can confirm these results in Phase III multi-country trial to be started in near future", said Dr. Dmytro Butov, the Principal Investigator of this study.

Killed M. vaccae preparation is the only therapeutic TB vaccine that has been ever approved by regulatory authorities. The injectable version, VACCAE™ produced by Anhui Longcom company, is currently sold in China for TB indication. Except small, ten-patient trial, conducted in Argentina in 2010 by John Stanford and colleagues, all prior studies conducted during past two decades in over 20 countries were based on injectable formulation. The proprietary oral vaccine technology developed by Immunitor has obvious advantages and potential to address current challenges – offering faster, more efficacious and safer solution with high compliance rate. In addition, M. vaccae is inexpensive, made from readily available source, and does not require cold-chain storage – all these advantages suit ideally developing countries where TB has become the major healthcare problem.

"This is a revolutionary time in the field of immunotherapy. We are deeply satisfied by Dr. Butov’s findings," stated Aldar Bourinbaiar, Immunitor's Chief Executive Officer. "This is an exciting time for the company as we expand our tuberculosis program. Ukrainian team is the leader in immunotherapy of TB and will be key to advancing our efforts and more broadly our oral vaccine platform as an approach to treat not only TB, but a wide range of immune diseases."

About Immunitor Inc.
Immunitor is a commercial stage company committed to developing oral immunotherapies. Immunitor has several vaccines in development including hepatitis, influenza, malaria, cancer and atherosclerosis. For more information, please visit

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