Positive interim data from ongoing V5 Phase IIb imm01 trial against tuberculosis

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Immune Network Ltd., a company in the business of development and commercialization of immune therapies, announced today that its newly acquired business, Immunitor Inc., has published interim data from the ongoing Phase IIb imm01 clinical trial of V5 in tuberculosis (including multidrug resistant TB, MDR-TB) conducted at its second site in Ukraine. The results from the Department of Phtysiatry and Pulmonology of Kharkov Medical University appeared in peer-reviewed Journal of Immune Based Therapies and Vaccines - an open access journal from BioMed Central (http://www.jibtherapies.com/content/9/1/3/abstract). The principal investigator of the study is Professor Svetlana Zaitzeva – an established expert in immunotherapy of tuberculosis (TB) and the editor of the authoritative book "Phtysiatry".

Mycobacterium tuberculosis -- already infecting the global population at the rate of one new case per second -- is one of the most dangerous infections, second after HIV. While the World Health Organization (WHO) estimates that one-third of the global population may currently have the bacterium that causes TB, the treatment -- a yearlong regimen of drugs developed more than four decades ago --  is failing, especially with multi-drug resistant TB and TB/HIV cases. Historically TB has been considered a "neglected disease" -- disease into which pharmaceutical companies have been reluctant to invest due to a perception of low commercial potential. The lack of interest from the industry combined with indifference of non-profit funding agencies recently made the WHO warn that a shortage of money could limit the progress in winning the war against TB. Dr Margaret Chan, the Director General of the WHO, said, "Many organizations in global health, like the Global Fund, the GAVI Alliance, and WHO itself, now face serious funding shortfalls." The current pipeline of TB drugs is limited and redundant; thus, radical new approaches are needed, including allocation of more funds into conceptually novel therapeutics and vaccines. "The money is not the only barrier, the main problem is that the public and physicians are not yet ready to embrace the concept of immune therapy of TB," says Aldar Bourinbaiar, the CEO of Immunitor.

The study has shown that V5 is safe, ameliorates symptoms of TB and improves quality of life. Outstanding efficacy after just 1 month of treatment was observed, including in MDR-TB patients, with conversion rate of sputum smear of 78.3% vs 0% in the placebo group. Scoring of sputum bacillary load at baseline and post-treatment revealed score reduction in 23 out of 24 (95.8%) V5 recipients.

"Immunitor's oral biologicals delivery platform is now being applied to other complex chronic medical conditions such as cancer and cardiovascular and metabolic diseases like atherosclerosis and obesity," said Vichai Jirathitikal – co-founder of Immunitor. "It's a question of time to convince healthcare providers that there are opportunities that will protect their patients much better than they are today," Vichai said. "The bottom line," he adds, "is that V5 is safe and effective, very simple to use requiring only one pill per day, unlike other vaccines can be kept at room temperature without refrigeration, and above all, is affordable, eliminating the need for more expensive second-line TB drugs. These advantages are essential for deploying V5 in developing countries in Africa as well as Asia, including India and China. We are excited that V5 can shorten treatment duration down to one month, as Zaitzeva and her team have convincingly shown in their study."

Considering that 2 billion people are latently infected with M. tuberculosis, it is likely that two different types of prophylactic TB vaccines will be needed: one is a so-called pre-exposure vaccine to prevent mycobacterial infection in naive, non-infected individuals and second, post-exposure vaccine, to prevent TB disease in tubercle bacilli carriers without exacerbating disease manifestations. Up to now, the majority of vaccine candidates are in the first category and only Mycobacterium vaccae and RUTI are considered to be in the second category. Studying V5 as a post-exposure vaccine can contribute to better understanding of the immunopathogenesis of TB resulting in the design of effective vaccines. In addition, V5 studies can yield important insights into correlates of immune protection, which are still poorly understood.


Immune Network Ltd


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