Immune Network to complete patient enrollment in Phase 2b imm01 trial for tuberculosis

Immune Network Ltd. (Pink Sheets:IMMFF), a company in the business of discovery and development of immune-based therapies, today announced that patient enrollment will be completed next week for the company's future partner Immunitor's Phase 2b imm01 trial of V5 immunotherapy in 120 patients with tuberculosis. V5 is an orally delivered once-daily tablet that in combination with standard TB drugs had so far produced clearance of Mycobacterium tuberculosis in sputum smear of about 95% of treated TB patients within one month.

M. tuberculosis is the cause of the second-most, after HIV, lethal infectious disease in the world. The usual duration of therapy with current TB drugs is 6-9 months or longer which can produce mycobacterial clearance in over 85% of patients. Currently available TB chemotherapy is not perfect; it requires several TB drugs to be taken in combination for long periods of time. This can cause multiple side effects, poor drug compliance, treatment failure, and the emergence of drug resistance with major social and economic consequences, especially in low-income countries in Asia, Africa, India and Eastern Europe where TB is rampant. Almost 9 million people develop TB and nearly two million people die annually. TB is increasingly untreatable due to antibiotic resistant strains that are especially dangerous to HIV positive people – killing 500,000 each year. The discovery of antibiotics revolutionized the treatment of TB and saved millions of lives. But they are losing effectiveness as the mycobacteria have become resistant to them. In the past 30 years only two new classes of antibacterials have been developed. It is clear that novel immune-based therapies and TB vaccines are urgently needed to complement antitubercular drug discovery.

The Phase 2b imm01 trial follows the recent publication in Journal of Vaccines & Vaccination of positive results from open label Phase 2 trial in 20 patients with TB who simultaneously had HIV and hepatitis C virus (HCV) co-infections (http://omicsonline.org/2157-7560/2157-7560-1-103.php). The imm01 study for which enrollment is being completed is designed to gain additional information on V5 efficacy against multi-drug-resistant TB (MDR-TB) and explore further dually infected TB/HIV individuals. In addition to anti-TB activity, the imm01 study will evaluate the impact on biomarkers of inflammation, reduction of fever, reversal of anemia and wasting, and other common TB symptoms as well as safety. So far 90 patients were enrolled and randomized in a 1:1 ratio to receive two months treatment with either once-per-day tablet of V5 or placebo, along with the standard of care TB drugs. After two months, patients in the active treatment arm and in placebo group will be compared and treatment will be continued for those who were not cured according to the WHO-recommended DOT strategy. Immunitor anticipates reporting preliminary results in February 2011 from a planned interim analysis of the first month of treatment from 2-month trial. Further information about imm01 trial is available at http://clinicaltrials.gov/ct2/show/NCT01222338

"The completion of enrollment in the Phase 2b study of V5 is an important step forward for Immunitor, and for our future partner Immune Network, in the joint effort to develop a potentially disease-curing medicine for "regular" TB as well as for more difficult-to-treat TB forms like MDR-TB and XDR-TB or the deadly duo TB/HIV co-infection," said Aldar Bourinbaiar, Immunitor's Chief Executive Officer. "V5 was originally designed for management of hepatitis B and C chronic viral diseases, but then we accidentally discovered its anti-TB activity," added Vichai Jirathitikal, Immunitor's co-founder and co-developer of the vaccine. "Based on what we know, we have very high level of confidence that V5 has the potential to provide patients an entirely new approach to controlling their chronic infectious diseases." In addition to V5, the company has demonstrated the potential of its oral vaccine platform in published studies for HIV indication, pandemic influenza, atherosclerosis and obesity. Immunitor's pipeline has other products currently under investigation, which include immunotherapies for a broad spectrum fungal and bacterial infections, malaria, autoimmune and inflammatory diseases, and cancer.