VANCOUVER, British Columbia, Aug. 10, 2011 (GLOBE NEWSWIRE) -- Immune Network Ltd., (Pink Sheets:IMMFF), reports that its business partner Immunitor company has launched a Phase 2 clinical trial of a novel anti-tuberculosis immunotherapy consisting of orally-delivered, heat-inactivated Mycobacterium vaccae. The new tableted preparation was formulated according to clinically validated proprietary technology developed by Immunitor company.
In extensive worldwide studies conducted during the past 30 years, the injectable version of M. vaccae has shown activity against drug-resistant TB and TB with HIV co-infection. Encouraging results from Phase 3 study of intradermal inoculation of M. vaccae in Tanzania, sponsored by the NIH, were published last year by investigators from the Dartmouth Medical School. So far this is the only TB vaccine candidate to reach Phase 3 level. However, due to inconvenience associated with invasive delivery of M. vaccae, which leaves permanent skin scars, coupled with infrequent dosing schedule, occasionally producing less-than-desired activity, the new oral formula of M. vaccae has been designed. It is easy to administer and its daily scheduled dose to be taken along with standard TB drugs is expected to boost the activity and shorten treatment duration down to one month instead of harrowing 6-24 months required to complete TB treatment.
This study is the second trial of oral M. vaccae. The first trial was conducted last year in Argentina under the leadership of Prof. John Stanford, one of the original innovators of M. vaccae immunotherapy and now a member of the Scientific Advisory Board of Immodulon Therapeutics based in London, UK. The outcome of his study produced convincing evidence that an oral formulation was safe and had biological activity not inferior to the original formula. As products containing M. vaccae have been already approved for sale in China and there is orphan drug designation for treatment of TB in the European Union and USA, it is expected that M. vaccae will have faster time to market in those regions.
The new pill formulation of M. vaccae as adjunct immunotherapy will be initially tested for one month in 20 individuals diagnosed with TB to determine whether it enhances the pharmacological activity of anti-TB drugs. These results will be compared to the control group where patients will receive TB drugs along with placebo pills. Immunitor has built considerable experience in conducting such trials and had recently completed a 120-patient placebo-controlled Phase 2 trial with a similar oral immune modulator, V5 Immunitor, which within one month produced 5-fold higher clearance of TB mycobacteria in sputum samples of treated patients. The favorable outcome was observed regardless of whether TB patients were drug-sensitive, drug-resistant, e.g., MDR-TB, or had HIV co-infection.
Tuberculosis along with HIV and malaria is the most serious infectious disease in the world. Today, one third of the world's population is infected with Mycobacterium tuberculosis – the infectious pathogen that causes tuberculosis. It has been estimated that every second someone in the world is infected, and that every year around nine million people will develop the disease and 1.7 million people will die from it. The WHO estimates that between 2000 and 2020, nearly a billion new people will be infected, of which 200 million will develop the disease, and 35 million will die if there is no improvement in handling the infection. Immune interventions with anti-mycobacterial vaccines such as M. vaccae may offer a solution to the current crisis.
The Immune Network Ltd logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=8008
Safe Harbor Statement
The information in this release, other than historical information, may be considered forward-looking statements within the provisions of the Private Securities Litigation Reform Act of 1995. 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.